da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B) (6), 2010, PASSED AWAY ON (B) (6), 2010. THE ATTENDING SURGEON INDICATED THAT THE SURGICAL PROCEDURE WENT WELL AND THERE WERE NO SYS MALFUNCTIONS. POSTOPERATIVELY, THE PT'S ABDOMINAL PAIN WAS MINIMAL AND HER VITAL SIGNS WERE STABLE, HOWEVER, SHE HAD A SEVERE MIGRAINE HEADACHE THE MORNING OF HER DISCHARGE. THE PT DECLINED MEDICATION FOR HER HEADACHE AND WAS DISCHARGED ON (B) (6), 2010. LATER THAT EVENING, THE PT COMPLAINED OF FATIGUE AND BECAME UNCONSCIOUS. THE PT EXPIRED THE FOLLOWING DAY. ON (B) (6), 2010, THE SURGEON ALSO INDICATED THAT THE AUTOPSY WAS NOT YET COMPLETE AND ISI WILL BE FORWARDED A COPY OF THE AUTOPSY REPORT WHEN IT BECOMES AVAILABLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: UROLOGIST CALLED TO REPORT PROBLEMS WITH ROBOTIC EQUIPMENT. THE UROLOGIST HAD TO CONVERT THE ROBOTIC PROSTATECTOMY CASE TO OPEN WHEN THE SYSTEM STOPPED WORKING. THE NEXT WEEK, THE SURGEON HAD TWO ROBOTIC PROSTATECTOMIES. DURING THE FIRST CASE THERE WERE 10 ALARMS WITH THE ERROR #20013, THAT SAID PRESS FAULT OVERRIDE BUTTON. DESPITE THIS PROBLEM THE FIRST CASE WENT AS PLANNED WITHOUT ANY OTHER ISSUES. DURING THE SECOND CASE THE SAME PROBLEM WITH THE FAULT ALARM OCCURRED THREE TIMES; ON THE THIRD TIME THE FAULT DID NOT OVERRIDE. THE MANUFACTURER WAS CONTACTED USING THE DAVINCI HELP NUMBER. WE WERE INSTRUCTED TO UNDOCK THE ROBOT COMPLETELY AND POWER DOWN. I WAS INSTRUCTED TO CHECK SOME CONNECTIONS ON THE CONSOLE, WHICH WERE FINE. THEN WE TURNED ON THE ROBOT AND STARTED AGAIN. WE HAD ANOTHER FAULT THAT WE COULD NOT OVERRIDE, SO I CALLED THE COMPANY AGAIN, HAD THE SURGEON PRESS THE EMERGENCY STOP BUTTON AND THEN FAULT OVERRIDE. THIS WAS TO RELEASE THE INSTRUMENTS' GRASPS ON THE TISSUE. AT THAT TIME THERE WAS A BLEEDER THAT HADN'T FULLY GOTTEN UNDER CONTROL BECAUSE THE ROBOT WAS FROZEN. THERE WERE THREE MORE FAULTS BEFORE WE HAD ANOTHER IRRECOVERABLE FAULT. THE SURGEON DECIDED TO COMPLET

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI SI THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS DUE TO RADIAL NERVE DAMAGE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PT WHO UNDERWENT A DA VINCI S TORS PROCEDURE ON (B) (6), 2010, EXPIRED ON (B) (6), 2010. ON MAY 4, 2010, THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE INFORMED ISI THAT THERE WERE NO ACUTE COMPLICATIONS WITH THE CASE AND THE PT WAS DISCHARGED 4-5 DAYS AFTER THE PROCEDURE WAS PERFORMED. THE SURGEON ALSO MENTIONED THAT FOLLOW-UP WAS CONDUCTED WITH THE PT APPROX ONE WEEK AFTER THE OPERATION AND THE PT WAS FOUND TO BE DOING WELL. SHORTLY AFTER, THE PT BEGAN EXPERIENCING POST-OPERATIVE BLEEDING AND PASSED AWAY. THE SURGEON INDICATED THAT HE DOES NOT BELIEVE THAT THE ROBOTIC PROCEDURE WAS THE DIRECT CAUSE OF THIS UNFORTUNATE EVENT, BUT RATHER THIS IS THE TYPE OF COMPLICATION THAT IT ASSOCIATED WITH THESE TYPE OF SURGICAL PROCEDURES. ON MAY 20, 2010, THE SURGEON INDICATED THAT THEY DO NOT HAVE ACCESS TO THE PT'S DEATH CERTIFICATE OR THE HOSPITAL RECORDS FROM THE INSTITUTION THAT THE PT WAS TAKEN TO ON (B) (6), 2010. ADDITIONALLY, THE PT'S FAMILY INFORMED THE SURGEON VIA TELEPHONE THAT THEY DID NOT SEEK AN AUTOPSY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS IN HER HANDS AND FINGERS AND SHARP PAIN AND TINGLING IN HER LEGS. PER THE SURGEON THAT PERFORMED THE OPERATION, THE MYOMECTOMY PROCEDURE TOOK LONGER THAN ANTICIPATED, APPROXIMATELY 5 HOURS, WITH THE PATIENT IN THE TRENDELENBURG POSITION. PER THE OPERATIVE REPORT THE PATIENT TOLERATED THE ENTIRE PROCEDURE WELL WITH GOOD HEMOSTASIS AND MINIMAL BLOOD LOSS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S COX CRYO-MAZE ATRIAL FIBRILLATION PROCEDURE, THE PATIENT SUFFERED FROM HEPATORENAL FAILURE AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). IT WAS REPORTED THAT THE PATIENT EXPIRED TWO DAYS AFTER THE PROCEDURE. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING A DISSECTION, THE MONOPOLAR FOOT PETAL WAS PRESSED, HOWEVER, THE BIPOLAR ENERGY BECAME ACTIVATED. THE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND CREATED A SUPERFICIAL LACERATION TYPE BURN TO THE PATIENT'S BOWEL. A GENERAL SURGEON REVIEWED THE INJURY AND DETERMINED THAT THE BURN WAS NOT THROUGH AND THROUGH AND DID NOT REQUIRE REPAIR, HOWEVER, THE SURGEON PLACED ONE SUTURE IN THE PATIENT'S BOWEL AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND NO FURTHER INSTANCES OF THE EVENT WAS REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS INDICATING THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, WHILE THE SURGEON WAS PERFORMING NODE DISSECTION, THE SURGEON CUT THE PATIENT'S ILIAC ARTERY AND VEIN CAUSING BLEEDING FROM THOSE VESSELS. A HEMO-CLIP WAS APPLIED TO THE AFFECTED AREA, HOWEVER, THE CLIP TORE THROUGH THE AREA WHERE THE CLIP WAS APPLIED CAUSING SIGNIFICANT HEMORRHAGE FROM THE PELVIC VESSELS. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN LAPAROTOMY TECHNIQUES. THE PATIENT EXPIRED ON (B)(6) 2012.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A LAPAROSCOPIC SUBTOTAL COLECTOMY WITH ILEOSIGMOID ANASTOMOSIS WITH DA VINCI-ASSISTED MOBILIZATION OF THE DISTAL SIGMOID DUE TO UNRESECTABLE, PREMALIGNANT TRANSVERSE COLON POLYPS AND CHRONIC CONSTIPATION ON (B)(6) 2010. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, AFTER TROCAR PLACEMENT WAS PERFORMED, THE SURGEON NOTED THAT THE ROBOT WAS NOT AVAILABLE FOR USE. ONCE THE ENTIRE SMALL BOWEL, CECUM, HEPATIC, TRANSVERSE, SPLENIC, AND DESCENDING COLON WERE MOBILIZED LAPAROSCOPICALLY, THE ROBOT WAS DOCKED FROM THE LEFT SIDE AND THE REST OF THE SIGMOID WAS MOBILIZED DOWN TO THE LEVEL OF THE PELVIC BRIM. THE SURGEON NOTED THAT THE LEFT URETER WAS IDENTIFIED AND KEPT OUT OF HARMS WAY. THE ROBOT WAS THEN UNDOCKED. THE SURGEON NOTED THE TOTAL ROBOT TIME WAS LESS THAN 10 MINUTES. THE PROCEDURE CONTINUED WITH DISSECTION OF THE COLON AND ANTIMESENTERIC SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PHYSICIAN AT THE SURGEON SIDE CONSOLE INTERMITTENTLY FELT A SHOCK IN HIS FINGERTIPS FROM THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED TO THE SITE'S SECOND SURGEON SIDE CONSOLE TO COMPLETE THE PLANNED PROCEDURE AND NO FURTHER OCCURRENCES OF SHOCK WERE REPORTED. NO HARM TO THE PHYSICIAN OR PATIENT WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 2.5 HOURS INTO A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON BEGAN TO INITIATE A TOOL CHANGE TO SWITCH INSTRUMENTS. AT THIS TIME THE NURSE ASSISTANT WHO WAS RETRACTING THE PATIENT'S UTERUS, DROPPED THE UTERUS CAUSING THE SURGEON TO LOSE SITE OF THE TENNACULUM FORCEPS INSTRUMENT IN USE. THE PATIENT SIDE MANIPULATOR (PSM) ARM THAT THE TENNACULUM FORCEPS INSTRUMENT WAS INSTALLED ON BECAME UNRESPONSIVE. THE ISI REPRESENTATIVE ONSITE HAD THE SURIGCAL STAFF EMERGENCY STOP THE SYSTEM AND PERFORM A FAULT OVER-RIDE, HOWEVER, THE PSM CONTINUED TO BE UNRESPONSIVE. THE PATIENT'S UTERUS WAS MOVED, AND THE SURGICAL STAFF FOUND THAT THE TENNACULUM FORCEPS INSTRUMENT WAS CLOSED ON THE PATIENT'S RECTUM AND THEY WERE UNABLE TO RELEASE THE INSTRUMENT. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE INSTRUMENT WAS RELEASED AND REMOVED FROM THE PSM. A GENERAL SURGEON WAS REQUESTED TO ATTEND THE PROCEDURE AND ALTHOUGH THERE WERE NO VISIBLE HOLES, TEARS, OR PINCHES IN THE PATIENT'S RECTUM, HE PLACED A FEW SUTURES AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH OUT ANY FURTHER PATIENT HARM, INJURY OR ADVERSE OUTCOME REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED, THAT WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED BY THE PT THAT SHE RECENTLY HAD A DA VINCI HYSTERECTOMY PROCEDURE AND WAS UNDER ANESTHESIA FOR 8 HOURS INSTEAD OF THE EXPECTED 4 HOURS DUE TO HER BEING SEVERELY OVERWEIGHT. SHE STATED THAT SHE WOKE UP AND WAS UNABLE TO MOVE EITHER OF HER ARMS, HOWEVER, AFTER TIME, SHE WAS ABLE TO GET FULL USE OF HER LEFT ARM. SHE STATED HER RIGHT ARM IS STILL IN A LOT OF PAIN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE DAY FOLLOWING A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PT DEVELOPED COMPARTMENT SYNDROME IN THEIR RIGHT ARM. A SURGICAL PROCEDURE WAS PERFORMED TO RELIEVE PRESSURE TO THE PT'S AFFECTED AREA. NO ADD'L PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE FOR RENAL CELL CARCINOMA OF THE LEFT KIDNEY ON (B)(6) 2009 AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2009. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AS WELL AS PATHOLOGY REPORT, AUTOPSY REPORT, VARIOUS HOSPITAL RECORDS, AND DEATH CERTIFICATE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING THE DA VINCI SURGERY IN THE PROVIDED RECORDS. THE DA VINCI OPERATIVE REPORT DATED (B)(6) 2009 INDICATED THAT THE PATIENT WAS A (B)(6) MALE WITH A 3-4 CM SOLID ENHANCING TUMOR IN THE MIDDLE OF THE KIDNEY, CONSISTENT WITH RENAL CELL CARCINOMA. THE PATIENT OPTED TO UNDERGO A NEPHRECTOMY OF THE LEFT KIDNEY AND THE SURGEON HAD DISCUSSED THE RISKS OF THE SURGERY. NO INJURIES WERE NOTED TO ADJACENT ORGANS, INCLUDING SPLEEN, BOWEL, OR GREAT VESSELS. THERE WAS LESS THAN 300 ML OF BLOOD LOSS AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION OR MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES. AN OPERATIVE R

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL INC.(ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC-ASSISTED HYSTERECTOMY ON (B)(6) 2009. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: INTESTINES WRAPPED AROUND TUBE; PATIENT DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY SIX HOURS INTO A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE SURGEON DECIDED TO COMPLETE THE PROCEDURE VIA A THORACOTOMY. IT WAS REPORTED THAT THE PT EXPIRED SHORTLY AFTER THE PROCEDURE. REPORTEDLY, THE PT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON SEPTEMBER 18, 2009, A REUTERS ARTICLE TITLED "MEDICAL SOCIETIES PUSH STANDARDS FOR ROBOTIC SURGERY" WAS PUBLISHED. THE ARTICLE INCLUDES QUOTES FROM DR. KEVIN ZORN AND MENTIONS HIS RECOUNT OF A CASE WHERE A PATIENT DIED POST A DA VINCI PROSTATECTOMY PROCEDURE: "HE RECOUNTED ONE CASE OF A SURGEON WHO WAS USING THE SYSTEM FOR THE FOURTH TIME. AFTER EIGHT HOURS OF SURGERY, THE PROCTOR -- AN EXPERIENCED SURGEON WHO SUPERVISES THE OPERATION -- TOLD THE SURGEON THAT PROGRESS WAS TOO SLOW. HE RECOMMENDED THE SURGEON SWITCH TO CONVENTIONAL SURGERY, WHERE AN INCISION IS MADE FROM THE NAVEL TO THE PUBIC BONE TO ACCESS THE PROSTATE. AFTER THE PROCTOR LEFT THE OPERATING ROOM, THE SURGEON CONTINUED USING THE ROBOT. THE PATIENT LATER DIED FROM COMPLICATIONS." ON SEPTEMBER 29, 2009, UPON FOLLOWING UP, IT WAS DISCOVERED THAT ANOTHER DR WAS THE PROCTOR.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT TOWARD THE END OF A DA VINCI S SACRALCOPOPEXY PROCEDURE, THE CONSOLE SURGEON EXPERIENCED USER MESSAGE "LIGHTEN GRIP". THE CONSOLE SURGEON ATTEMPTED TO TROUBLESHOOT THE SYSTEM ERROR BY RELEASING THE GRIPS ON THE MASTER TOOL MANIPULATORS (MTM); HOWEVER, THE SYSTEM ERROR PERSISTED. THE CONSOLE SURGEON THEN PLACED THEIR HEAD BACK INTO THE HIGH RESOLUTION STEREO VIEWER (HSRV) LOCATED ON THE SURGEON'S CONSOLE AND ACCIDENTLY CLUTCHED AND CHANGED CONTROL OF THE PATIENT SIDE MANIPULATOR (PSM) FROM PSM 2 TO PSM 3. THE SURGEON WAS UNCLEAR WHY THE INSTRUMENT ON THE PSM 2 WAS NOT MOVING WHEN SHE NOTICED THAT SHE HAD ACCIDENTLY CLUTCHED AND GAINED CONTROL OF THE INSTRUMENT IN PSM 3. AT THIS POINT, THE SURGEON HAD ALREADY MOVED PSM 3 WITH INSTRUMENT DOWN CAUSING THE INSTRUMENT TO MAKE CONTACT AND INJURING THE PATIENT'S SACRAL. THE CASE WAS CONVERTED TO A TRADITIONAL OPEN PROCEDURE AND THE PATIENT'S INJURY WAS REPAIRED AND THE PROCEDURE WAS COMPLETED. AS OF 2009, THE PATIENT WAS REPORTED AS DOING WELL WITH NO FURTHER ISSUES.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT ELEVEN DAYS POST OP A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PT EXPIRED. REPORTEDLY, THE PT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL PROCEDURE. ON SEPTEMBER 24, 2009, AN ISI REPRESENTATIVE PROVIDED THE FOLLOWING ADD'L INFO: THE PT EXPERIENCED COMPLICATIONS RELATED TO ACUTE LUNG INJURY AND PULMONARY EMBOLISM. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO A THORACOTOMY TO COMPLETE THE PLANNED SURGICAL PROCEDURE EXPEDITIOUSLY TO ALLOW FOR TAKING THE PT OFF OF BYPASS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 4 DAYS POST OP, A DA VINCI SI HYSTERECTOMY PROCEDURE, A 5MM PERFORATION OF THE PT'S BOWEL WAS OBSERVED DURING A LAPAROSCOPIC COLOSTOMY PROCEDURE. IN 2009, THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFO: PRE-OPERATIVELY, THE PT EXPERIENCED COMPLICATIONS OF SEVERE BOWEL IMPACTION (HARD STOOL) THROUGHOUT THE ENTIRE LARGE INTESTINE DUE TO DIVERTICULOSIS. THE PT'S BOWEL WAS INFUSED WITH AN ENEMA AND CONTRAST ALL THE WAY TO THE CECUM TO AID IN THE MOVEMENT OF THE PT'S BOWEL. IN ADDITION, THE PT HAD A COLOSTOMY TUBE THAT PRESENTED LEAKAGE THUS CAUSING THE PT TO DEVELOP AN INFECTION. IT IS UNK HOW DAMAGE TO THE PT'S BOWEL OCCURRED; HOWEVER, THE PERFORATION MAY HAVE BEEN INTRODUCED DURING THE ENEMA AND CONTRAST PROCEDURE. THE PT REMAINS HOSPITALIZED AS OF THE SAME DAY. IN ADDITION, THE INFECTION IS UNDER CONTROL AND THE PT IS REPORTED TO BE DOING WELL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON ACTIVATED THAT MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WHILE IT WAS OUT OF THEIR FIELD OF VIEW AND ACCIDENTLY LACERATED THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE DAMAGE TO THE PATIENT'S ARTERY WAS REPAIRED USING A PRIMARY CLOSURE TECHNIQUE. THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS NOT EXPERIENCED ANY POST OPERATIVE COMPLICATIONS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT PASSED AWAY ON (B) (6) 2009, ELEVEN DAYS AFTER UNDERGOING A UROLOGIC PROCEDURE WITH THE DA VINCI S SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN 2008, IT WAS REPORTED THAT AFTER A SUCCESSFUL DA VINCI S MITRA VALVE REPAIR PROCEDURE, THE PT DEVELOPED COMPLICATIONS RELATED TO A HEPARIN INDUCED THROMBOCYTOPENIA. AS A RESULT, THE PT'S LEG WAS AMPUTATED. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THIS SITE DESPITE ATTEMPTS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A ROBOTIC DAVINCI CASE THE INSTRUMENT ARM GRASPER BROKE INSIDE PT, BUT STAYING INTACT. AFTER COMPLETION OF CASE A CUTDOWN WAS PERFORMED AT THE INCISION SITE ALLOWING REMOVAL OF INSTRUMENT. OP REPORT: INSTRUMENT THROUGH 3RD DAVINCI ARM SNAPPED AT LEVEL OF PORT AND GIVEN ANGULATION; WAS DIFFICULT TO REMOVE THROUGH POA. AT THE END OF THE CASE, ARM WAS MANIPULATED AND INSTRUMENT WAS PULLED ALONG WITH ARM AFTER EXTENDING INCISION BY 2-3CM. PELVIC CAVITY WAS IRRIGATED, FRAGMENTS FROM INSTRUMENT SHEATH WERE REMOVED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 2 DAYS POST A DA VINCI SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE PT DEVELOPED A PERITONITIS INFECTION AND EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, REGARDING A PATIENT THAT UNDERWENT A DA VINCI S PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT DIED ON (B)(6) 2013 DUE TO A RETAINED FOREIGN BODY LEFT INSIDE THE PATIENT DURING THE DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2009, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR PARAESOPHAGEAL HERNIA AND WAS DISCHARGED ON (B)(6) 2009. ACCORDING TO THE DA VINCI OPERATIVE REPORT, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARAESOPHAGEAL HERNIA REPAIR WITH NISSEN FUNDOPLICATION FOR HIS LARGE PARAESOPHAGEAL HERNIA WITH HIATAL HERNIA AND GASTROESOPHAGEAL REFLUX DISEASE. NO COMPLICATIONS WERE NOTED. ON (B)(6) 2009, THE PATIENT'S CT SCAN OF HIS ABDOMEN REVEALED A GAS FILLED STOMACH AND LOOPS OF LARGE AS WELL AS SMALL BOWEL SUGGESTING POSTOPERATIVE ILEUS AND GAS WAS SEEN IN RECTUM. THE DISCHARGE SUMMARY INDICATED THAT THE PATIENT DID WELL POSTOPERATIVELY. HE UNDERWENT A SWALLOW STUDY, WHICH WAS FOUND TO BE WITHIN NORMAL LIMITS, THE PATIENT STARTED COMPLAINING OF SOME LEFT-SIDED DISCOMFORT AND WAS NOT GIVEN ANYTHING BY MOUTH. HIS

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S RENAL PROCEDURE, THE CONSOLE SURGEON INADVERTENTLY PERFORATED ONE OF THE PATIENT'S ARTERIES RESULTING IN BLOOD LOSS BEYOND THE POINT OF REVIVAL. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THREE DAYS AFTER A SUCCESSFUL DA VINCI S HYSTERECTOMY PROCEDURE, THE PT WAS RE-ADMITTED TO THE HOSP WITH A TEMPERATURE AND PERITONITIS SYMPTOMS. TWO DAYS AFTER BEING ADMITTED, A DIAGNOSTIC LAPAROSCOPY PROCEDURE WAS PERFORMED, RESULTING IN THE DISCOVERY OF EIGHT SITES ON THE PT'S SIGMOID COLON NEEDING OVER SEWING. SIX OF THE EIGHT SITES WERE IDENTIFIED AS THERMAL BURNS. NO ADDITIONAL PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI UROSTOMY PROCEDURE ON (B)(6) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'PATIENT HAD A FEMORAL ARTERY NICKED, AND HE BLED TO DEATH.'

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING DA VINCI S RADICAL NEPHRECTOMY PROCEDURE PERFORMED IN 2009, THE SURGEON ACCIDENTLY LIGATED AND CUT THE PT'S SUPERIOR MESENTERIC ARTERY. THE PROCEDURE WAS CONVERTED TO A TRADITIONAL HAND ASSISTED OPEN PROCEDURE. THE PT EXPIRED POSTOPERATIVELY IN THE SAME DAY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PT DEVELOPED RIGHT SHOULDER PARALYSIS. REPORTEDLY, PRIOR TO STARTING THE PLANNED SURGICAL PROCEDURE, THE SITE EXPERIENCED DIFFICULTIES PLACING THE PT IN THE TRENDELENBURG POSITION AND THE PT EXPERIENCED LABORED BREATHING.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT IN 2009, AFTER A SUCCESSFUL DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PATIENT EXPERIENCED DIFFICULTIES COMING OFF OF CARDIOPULMONARY BYPASS. THE PT'S HEART WAS SAID TO NOT BE CONTRACTING. TWO DAYS LATER, THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR "VENTRICULAR SYSTEM." THE PT WAS REMOVED FROM LIFE SUPPORT AFTER IT WAS DEEMED THAT IT WOULD NOT BE POSSIBLE TO PERFORM "VENTRICULAR SYSTEM." THE PT EXPIRED IN THE SAME DAY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S LUNG BIOPSY SURGICAL PROCEDURE, THE PT EXPIRED. THE SITE STATED THAT THE PLANNED DA VINCI S PROCEDURE WAS SUCCESSFULLY COMPLETED, HOWEVER, THE PT WAS IN OVERALL POOR HEALTH.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A PANCREATIC SURGICAL PROCEDURE WITH THE DA VINCI SURGICAL SYSTEM ON (B)(6) 2009. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY DIED. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ASSISTED RADICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, BILATERAL PERIAORTIC LYMPHADENECTOMY, AND OMENTECTOMY ON (B)(6) 2009 FOR CLINICAL STAGE II UTERINE SEROUS CARCINOMA. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. PER THE OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, AND/OR AN ACCESSORY OCCURRED DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED, EXTUBATED, AND BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 50 ML. ON (B)(6) 2009, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH SMALL BOWEL RESECTION AND ANASTOMOSIS. PER THE OPERATIVE REPORT, THE PATIENT HAD DEVELOPED RIGHT LOWER LOBE PNEUMONIA AFTER UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2009 AND WAS NOTED TO BE CLINICALLY SEPTIC WITH INCREASING ABDOMINAL DISTENSION AND DISCOMFORT SUSPICIOUS FOR AN UNDERLYING ABDO

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT WAS VERY SICK AND THE CASE WAS DIFFICULT. THE PATIENT WAS ALSO LARGE AND THE PROSTATE WAS LOCATED DEEP INSIDE THE PATIENT'S PELVIS. IT WAS THE SURGEON'S FIRST PROSTATECTOMY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM AND THE PROCEDURE WAS GOING SLOWLY, WITH THE SURGEON FIGHTING BOWEL THE ENTIRE CASE. NO SYSTEM MALFUNCTION OCCURRED AND ALL SURGICAL TASKS HAD BEEN PERFORMED CORRECTLY, HOWEVER, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE DUE TO THE LENGTH OF TIME IT WAS TAKING TO COMPLETE THE PROCEDURE. TWO DAYS POST-OP, THE PATIENT EXPIRED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S SACROCOLPOPEXY PROCEDURE, THE PT DEVELOPED DEEP VIN THROMBOSIS (DVT). NO ADDITIONAL PT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S NEPHRECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING THE HILAR DISSECTION TECHNIQUE, THE PATIENT BEGAN TO HEMORRHAGE. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUE. DESPITE EFFORTS FROM THE SURGICAL STAFF, THE PATIENT HEMORRHAGING WAS NOT ABLE TO BE CONTROLLED AND THE PATIENT EXPIRED. BASED ON THE INFORMATION PROVIDED BY THE SITE, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM DID NOT MALFUNCTION AND DID NOT CONTRIBUTED TO THE PATIENT'S DEATH.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT DEVELOPED BILATERAL LEG NERVE PALSY. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SURGICAL PROCEDURE, THE ENDOSCOPE TIP BECAME VERY HOT AND BURNT THE PATIENT'S BOWEL. SURGICAL INTERVENTION WAS NOT REQUIRED, AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN 2009, INTUITIVE SURGICAL WAS FORWARDED VOLUNTARY REPORT BY THE FDA FOR A PT DEATH AT HOSPITAL. THE REPORT DETAILS ARE PROVIDED BELOW: CDRH MAUDE EVENT REPORT 2009. REPORT OUTCOME ATTRIBUTED TO EVENT: DEATH. DATE RECEIVED: 2009. EVENT DATE: 2009. EVENT DESCRIPTION THE FOLLOWING MONTH: HEALTHY FEMALE FOR OVARIAN CYSTECTOMY USING THE DAVINCI ROBOT. PT SUFFERED FATAL CARDIAC ARREST IN THE MIDDLE OF THE PROCEDURE. HISTORY OF HTN, BUT OTHER WISE HEALTHY. NO AUTOPSY DONE. DEVICE INFORMATION: BRAND: DAVINCI ROBOT. DEVICE OPERATOR: HEALTH PROFESSIONAL. DEVICE AVAILABLE FOR EVALUATION: Y. EXPIRATION DATE: IS REPORTER A HEALTH PROFESSIONAL?: Y.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HEART VALVE REPAIR PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT DURING THE SURGERY, THE PATIENT EXPERIENCED INTERNAL BLEEDING AND INTERNAL BURNS OCCURRED. THE LEGAL DOCUMENT ALSO ALLEGES THAT THE PATIENT SUBSEQUENTLY EXPIRED ON AN UNSPECIFIED DATE AFTER BLOOD VESSELS WERE DAMAGED. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. BASED ON THE LEGAL DOCUMENT PROVIDED, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO REPORTEDLY UNDERWENT A DA VINCI-ASSISTED ROBOTIC PROCEDURE - NEPHRECTOMY FOR RENAL MASS ON (B)(6) 2008. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT. ISI WAS ONLY PROVIDED A LEGAL CLAIM FORM. THE LEGAL DOCUMENT STATES THAT ON (B)(6) 2008, THE PATIENT UNDERWENT ROBOTIC SURGERY FOR REMOVAL OF A RENAL MASS. DURING THE ROBOTIC SURGERY THE ROBOT PERFORATED THE PATIENT'S ARTERY LEADING TO IS [SIC] OTHER KIDNEY. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT AS A RESULT, THE PATIENT WAS NOT A CANDIDATE TO RECEIVE THE CANCER TREATMENT, INTERLEUKIN II, TO FIGHT HIS KIDNEY CANCER. THE PATIENT PASSED AWAY ON (B)(6) 2013 FROM METASTATIC RENAL CANCER. NO FURTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER A DA VINCI HYSTERECTOMY PROCEDURE, DURING THE CYSTOSCOPY, IT WAS FOUND THAT THE PATIENT'S URETER HAD BEEN DAMAGED. THE URETER WAS REPAIRED VIA A URETERONEOCYSTOTOMY PROCEDURE, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO ADDITIONAL PATIENT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 8 DAYS AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT UNDERWENT AN EXPLORATORY LAPAROSCOPY PROCEDURE WHERE A BOWEL PERFORATION WAS DISCOVERED. THE PERFORATION WAS REPAIRED, HOWEVER, THE PT BECAME SEPTIC DUE TO A BILIOUS FLUID LEAKAGE. THE PT WAS IN CRITICAL CARE FOR 2 WEEKS AND WAS THEN TRANSFERRED TO LONG TERM CARE. NO ADD'L PT HARM OR ADVERSE OUTCOME WAS REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE TO REMOVE A PELVIC MASS, THE CONSOLE SURGEON UNINTENTIONALLY CLIPPED THE PT'S SUPERIOR MESENTERIC ARTERY. AFTER THE PROCEDURE WAS COMPLETED, THE PT WENT INTO ORGAN FAILURE WHILE ON THE FLOOR AND EXPIRED. NO ADDITIONAL INFO HAS BEEN PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI S MITRAL VALVE REPAIR SURGICAL PROCEDURE AND WHILE RE-INFLATION OF THE PT'S RIGHT LUNG, THE SURGICAL STAFF NOTICED A VERY LOW OXYGEN (O2) SATURATION. AS A RESULT OF THE LOW O2 SATURATION, THE SURGICAL STAFF DECIDED TO PUT THE PT ON BYPASS IN ORDER TO SCOPE THE LUNGS. THE SURGICAL STAFF FOUND THAT FLUID HAD ACCUMULATED IN THE PT'S RIGHT LUNG. DESPITE EFFORTS, THE PT WAS NOT ABLE TO REGAIN FUNCTION OF THE RIGHT LUNG AND WAS TRANSFERRED TO THE ICU. THE PT EXPIRED DUE TO MULTI-ORGAN FAILURE, HYPOXIA, AND ACUTE PULMONARY EDEMA OF THE RIGHT LUNG.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI ESOPHAGOGASTRECTOMY FOR ESOPHAGEAL ADENOCARCINOMA ON (B)(6) 2008. A COMBINATION OF STANDARD LAPAROSCOPIC AND ROBOTIC ASSISTED LAPAROSCOPY WAS PERFORMED. THE SURGEON WENT BACK AND FORTH BETWEEN ROBOTIC ASSISTED AND NON-ROBOTIC LAPAROSCOPIC TECHNIQUE DEPENDING UPON WHICH TASKS WERE BEING ACCOMPLISHED. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT (S) AND SUPPLEMENTAL HOSPITAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY DURING ANY PORTION OF THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE BARRETT'S ESOPHAGUS CHANGES. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, THERE WERE ADHESIONS IN THE UPPER ABDOMEN, LEFT ABDOMEN AND RIGHT ABDOMEN. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. AT THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT UN