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Safety

When considering surgical options, many patients have concerns about safety. Some patients may question whether da Vinci Surgery is as safe as open surgery or traditional laparoscopic surgery. In fact, the da Vinci System has been used successfully worldwide in approximately 1.5 million various surgical procedures to date.

da Vinci offers multiple redundant safety features. First and foremost, the da Vinci System cannot be programmed, nor can it make decisions on its own. Instead, the da Vinci System requires that every surgical maneuver be performed with direct input from your surgeon.

 

With da Vinci Surgery, as with traditional surgical methods, you are under the care of your surgeon and his or her supporting team. Your surgeon requires at least one assistant at your side during surgery. This team-member assists with tasks such as switching between instruments, to provide your surgeon with the optimal da Vinci instrument for the procedure step being performed.

Just a few feet away, your surgeon operates using the console controls. As your surgeon maneuvers the controls, da Vinci scales, filters and translates his or her wrist and finger movements into precise movements of miniaturized instruments at the patient-side cart.

Tremor reduction minimizes unintended movements, which means that da Vinci instruments can move in a more precise manner than a human hand. And because the da Vinci Patient Cart does the work of holding and repositioning the instruments and camera – and because your surgeon operates while seated – surgeons can experience much less fatigue in performing surgery with the da Vinci System.

Finally, during the course of an operation, the da Vinci System will perform millions of safety self-checks. The System is designed to be fail-safe, which means that in the event of power interruption or a safety-check failure, the System is designed to shut down safely, allowing the surgeon to remain in control of the procedure.

PN 1002305 Rev A 04/2013


Serious complications may occur in any surgery, including da Vinci® Surgery, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection and internal scarring that can cause long-lasting dysfunction/pain. Risks of surgery also include the potential for equipment failure and/or human error. Individual surgical results may vary.

Risks specific to minimally invasive surgery, including da Vinci Surgery, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; temporary pain/discomfort from the use of air or gas in the procedure; a longer operation and time under anesthesia and conversion to another surgical technique. If your doctor needs to convert the surgery to another surgical technique, this could result in a longer operative time, additional time under anesthesia, additional or larger incisions and/or increased complications.

Patients who are not candidates for non-robotic minimally invasive surgery are also not candidates for da Vinci Surgery. Patients should talk to their doctor to decide if da Vinci Surgery is right for them. Patients and doctors should review all available information on non-surgical and surgical options in order to make an informed decision. For Important Safety Information, including surgical risks, indications, and considerations and contraindications for use, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com/safety. Unless otherwise noted, all people depicted are models.

© 2014 Intuitive Surgical. All rights reserved. All product names are trademarks or registered trademarks of their respective holders.

Content provided by Intuitive Surgical.

Patient Facing – Surgical Risks
Serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Also, some medical conditions can increase the risks of any surgery. Patients should discuss pertinent surgical risks with their doctors.

This document provides a summary of the risks associated with surgery and includes four different sections.

·        Section I includes the negative outcomes, risks and complications of any type of surgery.

·        Section II includes the negative outcomes, risks and complications of minimally invasive surgical techniques.

·        Section III includes the negative outcomes, risks and complications of da Vinci Surgery.

·        Section IV includes the negative outcomes, risksand complications of representative, specific surgical procedures.

I.                Negative Outcomes, Risks, and Complications of Any Surgical Type
This section covers negative outcomes, risks and complications associated with any type of surgery. Common approaches/methods of surgery include: open surgery (through a large incision), thoracotomy incision (through a large chest incision), transoral surgery (through the mouth) or laparoscopic surgery (through a few small incisions or the belly button) with traditional laparoscopy or da Vinci robotic-assisted laparoscopy.

1.      During Surgery

·        Loss of a large amount of blood (blood transfusion needed)

·        Any inadvertent cut, tear, puncture, burn or injury to organ , structure, or tissue , including , but not limited to:

o   Major blood vessel

o   Hollow organ, such as the bowel or bladder

o   Solid organ, such as the spleen, kidney,  heart , lungs or liver

o   Ureter (tubes that carry urine from the kidneys to the bladder)

o   Nerves

·        Loss of a needle, piece of an instrument or any other object used during surgery in patient’s body

·        Anesthesia risks (anesthesia is medicine that allows patients to sleep deeply and not feel pain during surgery): heart attack, stroke, blood clotting deep in the body, blocked lung artery, pneumonia (serious lung infection), dental injury, injury to the vocal cord and death

 

2.      After Surgery

The complications listed below may go away on their own, with standard treatment from a doctor, or may require: medicine, radiological intervention (allows doctors to see inside your body with imaging such as X-rays, CT or MRI scans or ultrasound), admission back into the hospital, extended hospital stay, and/or another operation.

·        Bleeding

·        Urinary tract infection and/or urine will not empty completely from the bladder

·        Blocked intestine or small bowel, nausea/vomiting

·        Heart attack or irregular heartbeat, inflammation of the sac covering the heart

·        Blood clot in a vessel that breaks away and travels to another blood vessel (often in the brain, GI tract, kidneys or leg), blood clotting deep inside the body, or blocked lung artery (usually blocked by a blood clot)

·        Collapsed lung, pneumonia (serious lung infection), build-up of fluid between the layers of tissue lining the lungs and chest cavity, abnormal build-up of fluid in the air sacs of the lungs which leads to shortness of breath, need for re-intubation (tube inserted in the mouth to help support breathing), or prolonged intubation

·        Infection, blood build-up outside of vessels, fluid build-up, pus build-up in the abdomen, pelvis or chest

·        Infection of the cavity where organs like the stomach and colon lie

·        Breakdown and release of muscle fiber into the blood stream which can cause kidney damage

·        Large amount of drainage from wound, or drainage which lasts a long period of time

·        Infection at the incision site

·        Bursting of the wound at the incision site

·        Hernia (bulging of organ or fatty tissue) at the incision site

·        Sudden kidney failure

·        Nerve disorder that causes weakness, numbness, tingling or pain (neuropathy)

·        Loss of vision that lasts for a short period of time or does not go away

·        Spread of cancer cells

·        Major stroke or mini “warning” stroke

·        Inability to work

·        Symptoms or disease may return

·        Death

II.             Negative Outcomes, Risks and Complications of Minimally Invasive Surgery
This section covers negative outcomes, risks and complications of minimally invasive surgery (through one or a few small incisions), in addition to the risks above. Examples include traditional laparoscopy, thoracoscopy, transoral endoscopy and da Vinci robotic-assisted laparoscopy.

1.      During Surgery

·        Surgeon must switch from minimally invasive surgery to open surgery (through a large incision) or hand-assisted surgery. This is usually due to: patient anatomy/frame, severe scarring or swelling of tissues, injury during surgery, technical challenges, cancer that can be seen in more places than first thought, or the patient cannot tolerate gas/air in abdomen (used to inflate the abdomen during minimally invasive surgery)

·        Longer operating and anesthesia time

·        Surgical instrument or equipment injures hollow or solid organ(s) or blood vessel(s)

·        Short-term nerve damage caused by how the patient was positioned on the operating table

·        Complications or injury to the eyes/vision, face or larynx (voice box) caused when the patient’s head is placed lower than his/her feet on the operating table

 

2.      After Surgery

·        Shoulder pain

·        Pain from the gas used during the surgery

 

III.           Negative Outcomes, Risks, and Complications of da Vinci Robotic–Assisted Surgery
In addition to the risks in I and II above, which are not unique to da Vinci, this section covers negative outcomes, risks and complications of da Vinci robotic-assisted surgery. Surgery using the da Vinci robotic surgical system may be associated with longer operative and anesthesia times. As with any surgical device, there is also the risk that the da Vinci robotic surgical system could malfunction or fail leading to serious injury or the need to switch to another type of procedure. Switching to another procedure type could also result in a longer procedure time, a longer time under anesthesia and increased complications.

 

IV.           Negative Outcomes, Risks, and Complications of Representative, Specific Procedures
This section covers negative outcomes, risks, and complications of representative, specific procedures in addition to the risks listed in sections I, II and III. It is not based on whether the surgeon operates using open surgery, a large chest incision, traditional laparoscopy or da Vinci robotic-assisted laparoscopy.

 

Urology
Radical Prostatectomy (removal of prostate gland and some surrounding tissue): leaking of urine, urgent need to urinate, cannot get or keep an erection, rectal or bowel injury, narrowing of the urethra, pooling of lymph fluid in the pelvic area or legs.

Pyeloplasty (surgery for a urinary blockage): infection of the kidney, leaking of urine, narrowing of the urethra, bowel injury, kidney stones, narrowing or movement of the stent, blood in the urine, prolonged leaking of urine.

Cystectomy (removal of all/part of the bladder): leaking of urine, injury to the rectum, scar tissue that causes narrowing between two connected structures, fistula (abnormal bond of an organ, intestine or vessel to another part of the body), leaking of urine, urgent need to urinate, cannot get or keep an erection, abnormal pooling of lymph fluid.

 

Nephrectomy (kidney removal):  poor kidney function often due to limited blood flow, leaking of urine, cut or tear in the spleen, bowel injury, trapped air between the chest wall and lung, injury to diaphragm (muscle separating the chest from the abdomen), urinary fistula (abnormal bond of an organ, intestine or vessel to another part of the body), abnormal pooling of urine, limited or cut off blood supply to kidney, abnormal pooling of lymph fluid.

 

Ureteral Reimplantation (repositions how ureter connects to bladder): urinary tract infection that affects one or both kidneys, damage to urethra which can cause urine to collect in other areas of the body, scar tissue that causes narrowing at the site of the repair abnormal flow of urine from the bladder backwards to the kidneys.

 

 

Gynecology
Hysterectomy, Benign (removal of the uterus and possibly nearby organs): injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problems(scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates), injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), abnormal hole from the vagina into the urinary tract or rectum, vaginal tear or deep cut.   Uterine tissue may contain unsuspected cancer.  The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Hysterectomy, Cancer (removal of the uterus and possibly nearby organs): injury to the ureters (the ureters drain urine from the kidney into the bladder), vaginal cuff problem (replaces cervix): scar tissue in vaginal incision, infection, bacterial skin infection, pooling/clotting of blood, incision opens or separates, injury to bladder (organ that holds urine), bowel injury, vaginal shortening, problems urinating (cannot empty bladder, urgent or frequent need to urinate, leaking urine, slow or weak stream), abnormal hole from the vagina into the urinary tract or rectum, vaginal tear or deep cut.

Myomectomy (removal of fibroid tumors): tear or hole in uterus, split or bursting of the uterus, pre-term (early) birth, spontaneous abortion.  Uterine tissue may contain unsuspected cancer. The cutting or morcellation of uterine or fibroid  tissue during surgery may spread cancer, and decrease the long-term survival of patients.

Sacrocolpopexy (pelvic prolapse surgery): mesh erosion/infection caused by mesh moving from vaginal wall into surrounding organs causing the need for another operation, injury to rectum/bowel, injury to bladder (organ that holds urine), injury to the ureters (the ureters drain urine from the kidney into the bladder), front wall of the rectum pushes into the back wall of the vagina, prolapsed bladder (bladder budges into vagina when supportive tissue weakens), vaginal incision opens or separates, loss of bladder control, pooling of blood between bladder and pubic bone, pooling of blood between the anus and vagina.

Endometriosis resection (endometriosis surgery to remove implants): injury to the bowel, bladder (organ that holds urine) or ureters (the ureters drain urine from the kidney into the bladder).

 

General Surgery
Cholecystectomy (gallbladder removal): injury to the common bile duct (tube that carries bile from the gallbladder to the small intestine), leaking bile, inflamed pancreas (pancreatitis).

 

Nissen Fundoplication (acid reflux surgery): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

 

Heller Myotomy (swallowing disorder surgery): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

 

Paraesophageal Hernia (stomach bulges into chest through a hole in the diaphragm): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

 

Bariatric Surgery for Morbid Obesity includes: gastric bypass (stomach reduction surgery), sleeve gastrectomy and duodenal switch: leaking and/or narrowing at the spot where two parts of the bowel were reconnected, leaking from where the bowel is cut, malnutrition, dumping syndrome (food moves too quickly into small intestine),  dehydration, need for supplementation of vitamins, minerals and protein.

 

Gastrectomy (removal of all/part of the stomach): leaking from the stomach or where the stomach is reconnected to the bowel, narrowing at the spot where stomach is reconnected to the bowel, difficulty swallowing, collapsed lung.

 

Donor Nephrectomy (kidney removal in donor): poor kidney function, deep cut in the spleen, inflamed pancreas, collapsed lung, trapped air between the chest wall  and lung,  injury to the diaphragm( muscle separating chest from the abdomen), adrenal gland bleeding.

 

Adrenalectomy (removal of one or both adrenal glands): injury to the spleen, inflamed pancreas, injury to the diaphragm (muscle separating chest from the abdomen), adrenal gland bleeding.

 

Splenectomy (removal of all/part of the spleen): injury to the pancreas, injury to the kidneys or adrenal glands, inflamed pancreas, leak of pancreatic juices, and blood clot in the portal vein (large vein that moves blood from the spleen and GI tract to the liver).

 

Hernia Repair (ventral, incisional, umbilical, inguinal): recurrence, bowel injury, infection of mesh, urinary retention .For inguinal hernia repair: testicular injury

 

Pancreatic Surgery ( removal of all/part of the pancreas): inflamed pancreas, leak of pancreatic juices, narrowing or leaking at the spot where the pancreas is connected to the bowel, injury to the spleen or bowel, insufficient pancreatic function (for example, diabetes).

 

Bowel Resection and Other Colorectal Procedures (removal of all/part of the intestine): leaking and/or narrowing at the spot where two sections of bowel were reconnected, anal dysfunction (cannot empty bowel, frequent bowel movements, leakage or constipation).

 

Cardiac Surgery
Internal Mammary (Thoracic) Artery Mobilization: graft injury,  graft narrowing, cardiac arrest (heart stops beating), a clot of fat, blood or air creates a block in the bloodstream, heart is not able to pump as much blood through the body, bleeding disorder in which blood cannot properly clot, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, irregular heartbeat, heart blockage, lengthy time on a breathing machine (ventilator) of 48 hours or more, blood flow to the breastbone and surrounding structures stops.

 

Cardiac Tissue Ablation (abnormal heart rhythm procedure): blood vessel becomes blocked by a clot that moved from another part of the body, injury to a blood vessel to the heart, tear in the heart, injury to the esophagus.

 

 

Mitral Valve Repair (surgery on an abnormal/leaking mitral valve): repair fails requiring another operation, stroke caused by a clot that gets stuck in smaller arteries of the brain,  heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream, valve infection, irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack,  memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder cut in the major artery(ies) that sends blood to the pelvis and legs, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac, injury to circumflex coronary artery (blood vessel to heart), inadequate closure.

 

Endoscopic Atrial Septal Defect Closure (surgery to close a hole between two chambers of the heart): failed closure of the defect, stroke caused by a clot that gets stuck in smaller arteries of the brain,  heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems , fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream,  irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack,  memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder, cut in the major artery(ies) that sends blood to the pelvis and legs, lung dysfunction, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

 

Mammary to Left Anterior Descending Coronary Artery Anastomosis for Cardiac Revascularization with Adjunctive Mediastinotomy: graft injury or narrowing, blood vessel connection fails requiring another operation, stroke caused by a clot that gets stuck in smaller arteries of the brain, heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream, valve infection, irregular heartbeat that requires a pacemaker, kidney or lung failure, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack, memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder cut in the major artery(ies) that sends blood to the pelvis and legs, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

 

 

Pediatric Surgery
The Intuitive SurgicalEndoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others. The complications and risks listed below are not specific to the pediatric population but apply to procedures under consideration.

 

Pyeloplasty (surgery for a urinary blockage): infection of the kidney, a leaking of urine, narrowing of the urethra, bowel injury, kidney stones, narrowing or movement of the stent, blood in the urine, prolonged leaking of urine.

 

Ureteral reimplantation (repositions how ureter connects to bladder): urinary tract infection that affects one or both kidneys, damage to urethra which can cause urine to collect in other areas of the body, scar tissue that causes narrowing at the site of the repair abnormal flow of urine from the bladder backwards to the kidneys.

 

Cholecystectomy (gallbladder removal): injury to the common bile duct (tube that carries bile from the gallbladder to the small intestine), leaking bile, inflamed pancreas (pancreatitis).

 

Nissen Fundoplication (acid reflux surgery): tear/hole in the stomach lining, tear in the small intestine or esophagus, the stomach wrap around the esophagus pushes into the chest or breaks down, narrowing or tightening of the esophagus that makes swallowing difficult, collapsed lung, difficulty swallowing, hiatal hernia which occurs when the stomach bulges into the chest through a hole in the diaphragm (muscle separating the chest from the abdomen).

 

Aortic Ring Ligation (surgery to repair abnormal aorta/tissue): respiratory system fails (difficult or unable to breathe).

 

Patent ductus arteriosus (PDA) ligation (surgery to close/repair an opening in the ductus arteriosus blood vessel): abnormal breathing and heart rate, lung arteries stretch/widen, vocal cords do not work normally, lymph fluid collects around the lungs, collapsed lung.

 

Endoscopic atrial septal defect closure (surgery to close a hole between two chambers of the heart): failed closure of the defect, stroke caused by a clot that gets stuck in smaller arteries of the brain,  heart failure (heart cannot pump enough blood to the body), tear in the aortic wall causes it to separate, lengthy time on a breathing machine of 48 hours or more, lengthy time for a heart lung machine, extracorporeal membrane oxygenation (outside body technique to provide cardiac and respiratory support), intraaortic balloon pump (mechanical device to increase oxygen to cardiac muscles) or other cardiac assist systems, fluid in the lungs, sudden lack of blood flow to a limb due to a block in the blood stream,  irregular heartbeat that requires a pacemaker, sac-like cover around the heart becomes swollen and causes a low fever and chest pain for up to 6 months, bleeding disorder in which the blood cannot properly clot, heart attack,  memory loss and/or loss of mental clarity, infections which may affect the kidneys, chest, valves or bladder, cut in the major artery(ies) that sends blood to the pelvis and legs, lung dysfunction, pooling of blood between the chest wall and lung, pressure on the heart when blood/fluids build up between the heart muscle and its outer sac.

 

Thoracic Surgery
Pulmonary Resection (removal of part of lung): air leaks from lungs, lung infection,  lengthy time on a breathing machine of 48 hours or more,  abnormal/irregular heartbeat, breathing tube needs to be re-inserted, abnormal path between lung airways and lining, lung failure  lymph fluid collects around lungs, abnormal vocal cord function.

 

Esophagectomy (removal of part of esophagus): leaking from the stomach, lung infection, heart attack, heart failure, abnormal/irregular heartbeat, abnormal vocal cord function with change in voice or speech,excess lymphatic fluid in the pleural cavity ( space around the lungs)

 

Mediastinal Mass Resection (chest tumor removal): lengthy time on a breathing machine of 48 hours or more, air leaks out of lungs, fluid build-up around the heart, mixed respiratory syndrome, collapsed lung, injury to heart, abnormal vocal cord function, lymph fluid collects around lungs, need to cut breastbone.

 

Head and Neck Surgery
Thyroidectomy (thyroid gland removal): low levels of parathyroid hormone and calcium, Larynx (voice box) nerve damage that lasts or returns, breathing tube needs to be re-inserted, deep cut in windpipe, abnormal vocal cord function, deformed appearance,  lasting pain or numbness, cut across arteries and tissue in neck, change in voice or speech.  NOTE: thyroidectomy is not cleared by the FDA in the USA.

 

Transoral Robotic Surgery-TORS (head & neck surgery): bleeding that may be life-threatening, difficulty swallowing which could include the need for a permanent feeding tube without eating by mouth, breathing tube needs to be re-inserted, need to create breathing hole in the neck (tracheotomy and tracheostomy), need to use breathing tube and ventilator for a long time, changes to or loss of taste, tongue cannot move, difficulty opening mouth, broken teeth, narrowing of throat, changes in speech or voice quality, abnormal path from the gland that produces saliva, vocal cord damage, difficulty speaking, injury to teeth, difficulty breathing due to an airway blockage, loss of feeling in tongue, lip injury, injury to nerves in tongue and weak tongue. NOTE: Transoral Robotic Surgery is intended for use only in benign and early to moderate stage cancerous tumors (classified as T1 or T2) and for benign base of tongue resection procedures.


 

Surgeon Facing – Surgical Risks
Serious complications may occur with any surgery, including da Vinci Surgery, up to and including death. In addition, there are risks that are specific to certain surgical procedures. Certain pre-existing medical conditions can also increase the risks of any surgery. Surgeons should discuss pertinent surgical risks with their patients.

This document provides a summary of the risks associated with surgery and includes four different sections.

·          Section I includes the negative outcomes, risks and complications of any type of surgery.

·          Section II includes the negative outcomes, risks and complications of minimally invasive surgical techniques.

·          Section III includes the negative outcomes, risks and complications of da Vinci Surgery.

·          Section IV includes the negative outcomes, risks and complications of representative, specific surgical procedures.

I.                Adverse Events, Risks, and Complications of Any Surgical Type
This section covers adverse events, risks, and complications associated with all operative procedures in general and are NOT specific to the surgical method or approach used (for example, abdominal/laparotomy incision (“open surgery”), thoracotomy incision, da Vinci system robotic-assisted laparoscopy, and conventional laparoscopy).

1.      Intraoperative

·        Bleeding, excessive >500 mL, requiring blood transfusion

·        Injury (inadvertently caused by laceration, tear, perforation, puncture, electrocautery) to organ , structure,  or tissue , including , but not limited to: major blood vessel, hollow viscous organs (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung), ureter, nerve

·        Loss of needle, instrument fragment or any foreign body during surgery in patient’s body

·        Anesthesia risks (including heart attack, stroke, deep venous thrombosis, pulmonary embolism, pneumonia, dental injury, vocal cord injury and death)

 

2.    Postoperative

These complications may resolve on their own with non-operative therapy, may require medical/pharmaceutical treatment such as antibiotics, may require radiological intervention such as drain placement or embolization, may require prolonged hospitalization, may require re-admission to the hospital, or may require surgical intervention such as re-operation.

·        Bleeding

·        Urinary: urinary tract infection, urinary retention

·        Gastrointestinal: ileus, nausea/vomiting, small bowel obstruction

·        Cardiac: myocardial infarction, arrhythmia, pericarditis

·        Thromboembolic: deep venous thrombosis, pulmonary embolus

·        Pulmonary: atelectasis, pneumonia, pleural effusion, pulmonary edema, need for re-intubation or prolonged intubation

·        Infection / Hematoma / Fluid Collection / Abscess (intra-abdominal, intra-pelvic, intra- thoracic)

·        Peritonitis

·        Rhabdomyolysis

·        Serous drainage from wound, prolonged or excessive

·        Wound infection: incisional

·        Fascial dehiscence: incisional

·        Hernia: incisional

·        Renal: acute renal failure

·        Neuropathy; persistent pain

·        Visual loss, temporary or permanent

·        Spread of cancer cells

·        Cerebrovascular: transient ischemic attack, ischemic or hemorrhagic stroke

·        Inability to work

·        Recurrence of disease or symptoms

·        Death

 

II.             Adverse Events, Risks, and Complications of Minimally Invasive Surgery
This section covers adverse events, risks and complications associated specifically with operative procedures performed minimally invasively through an endoscopic approach in addition to the above listed risks (for example, conventional laparoscopy, transoral endoscopy and da Vinci system robotic-assisted laparoscopy).

1.    Intraoperative

·        Conversion to open or hand-assisted surgery (typically due to patient anatomy, severe inflammation or adhesions, intraoperative injury, technical malfunction, extent of malignant invasion, or inability of patient to tolerate pneumoperitoneum)

·        Veress needle or trocar injury to hollow viscous (bowel, bladder), solid organs (spleen, kidney, liver, heart, lung) or blood vessel

·        Longer operative and anesthesia time

·        Neuropraxia related to patient positioning

·        Ocular or laryngeal-facial complications related to trendelenberg position

 

2.    Postoperative

·        Shoulder pain

·        Gas pain

 

III.           Adverse Events, Risks and Complications of da Vinci robotic –assisted surgery
In addition to the risks in I and II above, which are not unique to da Vinci, this section covers negative outcomes, risks and complications of da Vinci robotic-assisted surgery. Surgery facilitated by the da Vinci Surgical System may be associated with longer operative and anesthesia times than surgery with other approaches. As with any surgical device, there is also the risk that the da Vinci robotic surgical system could malfunction or fail leading to serious injury or the need to switch to another type of procedure. Switching to another procedure type could also result in a longer procedure time, a longer time under anesthesia and increased complications.

 

IV.           Adverse Events, Risks and Complications of Representative Specific Procedures
This section covers adverse events, risks and complications associated with specific operative procedures, not specific to the surgical method or approach used (for example, abdominal/laparotomy incision, thoracotomy incision, da Vinci system robotic-assisted laparoscopy, and conventional laparoscopy). These procedural risks are in addition to the risks described under Sections I, II and III above.

 

Urology
Radical Prostatectomy: surrounding nerve damage which can lead to urinary incontinence and/or erectile dysfunction, rectal or bowel injury, urethral stricture, lymphocele, lymphedema; bowel obstruction

 

Pyeloplasty: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

 

Cystectomy: urine leak, rectal injury, anastomotic stricture, fistula formation, incontinence, impotence, pelvic lymphocele

 

Nephrectomy:  renal insufficiency, urine leak, splenic laceration, bowel injury, pneumothorax, diaphragmatic injury, urinary fistula, urinoma, renal infarction, lymphocele

 

Ureteral Reimplantation: pyelonephritis, urinary extravasation, anastomotic stricture, ureteral reflux

 

 

Gynecology
Hysterectomy (Benign): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal. Uterine tissue may contain unsuspected cancer.  The cutting or morcellation of uterine tissue during surgery may spread cancer, and decrease the long-term survival of patients

Hysterectomy (Malignant): urinary tract injury, vaginal cuff problem (separation, adhesions, granulation tissue, infection, cellulitis, hematoma), bladder injury, bowel injury, vaginal tear or laceration, vaginal shortening, voiding dysfunction, fistula formation: vesicovaginal, rectovaginal.

 

Myomectomy: uterine perforation, uterine rupture, preterm birth, spontaneous abortion Uterine tissue may contain unsuspected cancer.  The cutting or morcellation of uterine or fibroid  tissue during surgery may spread cancer, and decrease the long-term survival of patients

Sacrocolpopexy: mesh erosion/infection (if mesh used in repair) with need for re-operation, rectal injury, bladder injury, rectocele, cystocele, urinary tract injury, vaginal cuff dehiscence, urinary incontinence, hematoma (retropubic, perineal or other).

Endometriosis resection: bowel injury, bladder injury, urinary tract injury

 

General Surgery
Cholecystectomy: common bile duct injury; bile leak; pancreatitis

 

Nissen Fundoplication: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, peri-esophageal abscess, esophageal stricture, hiatal hernia

 

Paraesophageal and Other Hiatal Hernia Repairs: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia

 

Heller Myotomy: gastric, duodenal or esophageal perforation, herniation of wrap, dysphagia, pneumothorax, esophageal stricture, hiatal hernia

 

Bariatric Procedures (Sleeve Gastrectomy/ Roux-en-y gastric bypass, Duodenal Switch): anastomotic/staple line leak, malnutrition, anastomotic stricture, dumping syndrome, dehydration, dysphagia

 

Donor Nephrectomy: renal insufficiency, splenic laceration, adrenal hematoma, pancreatitis, pneumothorax, diaphragmatic injury

 

Gastrectomy: anastomotic or duodenal leak, anastomotic stricture, dysphagia, pneumothorax

 

Pancreatic Procedures (Pancreatectomy and Whipple Procedure): pancreatitis, pancreatic leak, anastomotic leak, anastomotic stricture, splenic injury, pancreatic insufficiency, intestinal injury

 

Adrenalectomy: splenic injury, pancreatitis, diaphragmatic injury, adrenal hematoma

 

Splenectomy: pancreatic injury, kidney injury, adrenal injury, pancreatitis, pancreatic leak, portal vein thrombosis

 

Hernia Repair (ventral, incisional, umbilical, inguinal): recurrence, bowel injury, mesh infection, urinary retention. .For inguinal hernia repair: testicular injury

Bowel Resection and Other Colorectal Procedures (Colectomy, Sigmoidectomy, Low Anterior Resection, APR, Intersphincteric Resection, Proctectomy, Rectopexy): anastomotic leak, anastomotic stricture, anorectal dysfunction

 

Cardiac Surgery
Internal Mammary Artery Mobilization: graft injury, graft stenosis, cardiac arrest,  embolism, low cardiac output syndrome, persistent coagulopathy, post-pericardiotomy syndrome, structural damage,  arrhythmia, heart block, prolonged ventilation >48 hours, sternal de-vascularization

 

Cardiac Tissue Ablation: thromboembolism, circumflex artery injury, cardiac perforation, esophageal injury

 

Mitral Valve Repair: failed repair requiring replacement or repair, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems,  pulmonary edema, acute limb ischemia, valve infection, arrhythmia requiring pacemaker implantation, post-pericardiotomy syndrome (low grade fever and chest pain up to 6 months), pericarditis, persistent coagulopathy, heart attack, pericardial tamponade, memory loss and/or loss of mental clarity, arterial dissection, circumflex coronary artery injury, inadequate closure

 

Endoscopic Atrial Septal Defect Closure: failed closure of defect, embolic stroke, ischemic heart failure, aortic dissection, prolonged ventilation >48 hours, prolonged  time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems,   pulmonary edema, acute limb ischemia, arrhythmia, heart block, cardiac arrest, hemothorax, pericardial tamponade, valve dysfunction, thromboembolism, thrombus formation, aortic dissection, arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy    

 

Mammary to Left Anterior Descending Coronary Artery Anastomosis for Cardiac Revascularization with Adjunctive Mediastinotomy: graft injury, graft stenosis, failed anastomosis, cardiac arrest, embolic stroke, aortic dissection, acute limb ischemia, heart attack, arrhythmias, prolonged ventilation >48 hours, prolonged  time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, valve dysfunction, hemothorax, pericardial tamponade, persistent coagulopathy, post-pericardiotomy syndrome, memory loss and/or loss of mental clarity, kidney or lung failure, heart failure

Pediatric Surgery
The Intuitive Surgical Endoscopic Instrument Control System has been successfully used in the pediatric surgical procedures listed below, among others. The complications / risks listed below are not specific to the pediatric population but are applicable for procedures under consideration.

Pyeloplasty: pyelonephritis, anastomotic leak, ureteral stricture, bowel injury, urinoma, stone formation, stent migration or obstruction, hematuria, prolonged urinary leak

 

Ureteral Reimplantation: pyelonephritis, urinary extravasation, anastomotic stricture, voiding dysfunction,

Cholecystectomy: common bile duct injury; bile leak; pancreatitis

 

Nissen Fundoplication: pneumothorax, gastric or duodenal perforation, wrap herniation/ breakdown, esophageal stricture, dysphagia, enterocutaneous fistula, hiatal hernia, para-esophageal hernia

 

Aortic Ring Ligation: respiratory failure

 

Patent Ductus Arteriosus Ligation: cardiorespiratory instability, ductal pseudoaneurysm, vocal cord dysfunction, pneumothorax, chylothorax, pulmonary arterial dilatation

 

Atrial Septal Defect Closure: structural deterioration of repair, arrhythmia, heart block, cardiac arrest, prolonged ventilation >48 hours, prolonged time for: a heart-lung bypass, extracorporeal membrane oxygenation, intraaortic balloon pump or other cardiac assist systems, hemothorax, pericardial tamponade, valve dysfunction,  thromboembolism, thrombus formation, aortic dissection, acute limb ischemia arterial dissection, acute respiratory distress syndrome (ARDS), post-pericardiotomy syndrome, pericarditis, heart failure, persistent coagulopathy

 

Thoracic Surgery
Pulmonary Resection (Wedge Resection, Segmentectomy, Lobectomy): persistent air leak, pneumonia, prolonged ventilation >48 hours, atrial fibrillation, acute respiratory distress syndrome (ARDS), chylothorax, re-intubation, arrhythmias, bronchopleural fistula, phrenic nerve injury, esophageal injury, recurrent laryngeal nerve injury leading to vocal cord dysfunction

 

Esophagectomy: anastomotic leak, pneumonia, cardiac complications (infarction, failure, atrial fibrillation), recurrent laryngeal nerve injury,chyle leak

 

Mediastinal Mass Resection: prolonged ventilation >48 hours, persistent air leak, pericardial effusion, mixed respiratory syndrome, chylothorax, pneumothorax, re-intubation, pneumonia, acute respiratory distress syndrome (ARDS), atrial fibrillation, cardiac injury, conversion to sternotomy, recurrent laryngeal nerve injury leading to vocal cord dysfunction, phrenic nerve injury

 

Head and Neck Surgery
Thyroidectomy: transient or permanent hypoparathyroidism/hypocalcemia, recurrent laryngeal nerve injury, re-intubation, tracheal laceration, vocal cord dysfunction, cosmetic deformity, persistent pain or numbness, transection of carotid sheath structures.  NOTE: Thyroidectomy is considered an off-label procedure in the US.

 

Transoral Robotic Surgery (TORS): transoral bleeding which could include life threatening bleeds, difficulty swallowing which could include need for a permanent feeding tube with no eating by mouth, airway obstruction, re-intubation, need for tracheotomy, tracheostomy placement, prolonged intubation and need for ventilation, paralysis of tongue, difficulty opening mouth or trismus, broken teeth, pharyngeal stenosis, laryngeal stenosis, changes in speech or voice quality, salivary gland fistula, vocal cord damage, speech and swallowing dysfunction, dysphagia, dysphonia,  lingual hypoesthesia, lip injury: abrasion, laceration, thermal trauma, dysguesia, hypoglossal nerve injury and tongue-weakness changes in taste sensitivity with loss of sense of taste. NOTE: Transoral Robotic otolaryngology surgical procedures are restricted to benign and malignant tumors classified as T1 and T2 and for benign base of tongue resection procedures.

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If you have questions about the da Vinci® Surgical System or about surgical procedures conducted with the da Vinci Surgical System, consult a surgeon that has experience with the da Vinci Surgical System. A list of surgeons that have experience with the da Vinci Surgical System can be found in the Surgeon Locator.

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