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 SURGICAL PROCEDURE ON (B)(6) 2010 AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT FOR A MODIFIED RADICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL LYMPHADENECTOMY, AND DEBULKING OF LEFT OBTURATOR ADENOPATHY WAS PERFORMED FOR CLINICAL STAGE IA2 ADENOCARCINOMA OF THE CERVIX. ADDITIONAL INFORMATION PROVIDED INCLUDES: DISCHARGE SUMMARIES, SUBSEQUENT OPERATIVE REPORTS, AND A DEATH CERTIFICATE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT WAS DISMISSED TO THE RECOVERY ROOM AND THEN DISCHARGED IN STABLE CONDITION ON (B)(6) 2010, THE SAME DAY. THE DISCHARGE SUMMARY NOTED THAT THE PATIENT HAD TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED IN STABLE CONDITION. ACCORDING TO THE PATIENT'S MEDICAL RECORDS DATED (B)(6) 2010 THROUGH (B)(6) 2011, THE PATIENT EXPERIENCED COMPLICATIONS THAT INCLUDED VAGINAL LEAKING, ABDOMINAL PAIN, ACUTE RENAL FAILURE, PSYCHOTIC BEHAVIO

CyberKnife — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A CLINICAL PUBLICATION TITLED, 'STEREOTACTIC BODY RADIATION THERAPY FOR HEAD AND NECK TUMOR: DISEASE CONTROL AND MORBIDITY OUTCOMES.' ACCURAY CONTACTED THE PHYSICIAN RESPONSIBLE FOR THE TREATMENTS. IT WAS CONFIRMED THAT THE COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PTS DID NOT HAVE ANY OTHER TREATMENT ALTERNATIVE DUE TO THE NATURE AND EXTENT OF DISEASE; CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THESE PTS. THE PTS RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYSTEM IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. THE REPORTED TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE GATHERING INFORMATION FOR A STUDY, THE SURGEON WAS MADE AWARE OF 3 EVENTS THAT OCCURRED 4 TO 7 DAYS POST A DA VINCI S TORS PROCEDURE WHERE THE PATIENT EXPIRED SECONDARY TO COMPLICATION RELATED TO THEIR CANCER. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. FOR THESE SIMILAR EVENTS, PLEASE SEE MDR'S 2955842-2010-00461 AND 2955842-2010-00462.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE GATHERING INFORMATION FOR A STUDY, THE SURGEON WAS MADE AWARE OF 3 EVENTS THAT OCCURRED 4 TO 7 DAYS POST A DA VINCI S TORS PROCEDURE WHERE THE PATIENT EXPIRED SECONDARY TO COMPLICATION RELATED TO THEIR CANCER. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. FOR THESE SIMILAR EVENTS, PLEASE SEE MDR'S 2955842-2010-00460 AND 2955842-2010-00462.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE GATHERING INFORMATION FOR A STUDY, THE SURGEON WAS MADE AWARE OF 3 EVENTS THAT OCCURRED 4 TO 7 DAYS POST A DA VINCI S TORS PROCEDURE WHERE THE PATIENT EXPIRED SECONDARY TO COMPLICATION RELATED TO THEIR CANCER. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION WITHOUT SUCCESS. FOR THESE SIMILAR EVENTS, PLEASE SEE MDR'S 2955842-2010-00460 AND 2955842-2010-00461.

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 ROBOTICALLY ASSISTED PYLORUS-SPARING PANCREATICODUODENECTOMY (WHIPPLE) PROCEDURE ON (B)(6) 2010 TO REMOVE A PANCREATIC MASS, WHICH TURNED OUT TO BE AN INTRADUCTAL PAPILLARY MUCINOUS NEOPLASM WITH MODERATE DYSPLASIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. PER THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2010, THE PATIENT PRESENTED WITH DIFFUSE ABDOMINAL PAIN. ABDOMINAL FLUID COLLECTION CULTURE + FOR E.COLI. DRAINAGE OF FLUID. ON (B)(6) 2010, THE PATIENT DEVELOPED EXTREME HYPOTENSION WITH INTRABDOMINAL BLEEDING. ON (B)(6) 2010, THE PATIENT WENT IN FOR A LAPAROTOMY. ON (B)(6) 2010, THE PATIENT HAD LAPAROTOMY INTRAABDOMINAL FUNGAL INFECTION AND MULTIPLE REVISIONS. ON (B)(6) 2010, THE PATIENT HAD LAPAROTOMY WITH ABD WASHOUT AND MULTIPLE REVISIONS. ON (B)(6) 2010, ATTEMPT TO CLOSE ABDOMEN. ON (B)(6) 2010, THE PATIENT EXPIRED FROM COMPLICATIONS PRESUMED TO BE MESENTERIC VEIN THROMBOSIS AND BOWEL ISCHEMIA. NO F

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 10 DAYS POST A DA VINCI SI SURGICAL PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL WITH UNKNOWN SYMPTOMS AND EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

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 ONE WEEK POST A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE SEPSIS. THE PATIENT HAD A DO NOT RESUSCITATE (DNR) ORDER ON FILE AND EXPIRED ONE WEEK LATER. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

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 HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR PELVIC MASS WITH ELEVATED CA-125 ON (B)(6) 2010 AND AT AN UNSPECIFIED DATE SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, PRE-SURGERY CLINIC NOTE, HOSPITAL ADMISSION NOTE, DISCHARGE SUMMARY AND PATHOLOGY REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING THE DA VINCI SURGERY. THE OPERATIVE REPORT WAS BRIEF AND DID NOT INCLUDE ANYTHING AFTER THE TITLE OPERATION. ESTIMATED BLOOD LOSS WAS LESS THAN 100 CC. THE OPERATIVE REPORT STATES THAT THERE WAS EXTENSIVE INTRAABDOMINAL ADHESIONS IN THE SITE OF THE PATIENT'S PREVIOUS SURGERY. FURTHERMORE IT STATES, EXTENSIVE ADHESIONS WERE LYSED AWAY FROM THE OPERATIVE FIELD IN ORDER TO SAFELY PLACE INSTRUMENTS. AFTER COMPLETION OF THE LYSIS OF ADHESIONS, THE RIGHT LATERAL ROBOTIC PORT WAS PLACED. IT CONTINUES, THE LYSIS OF ADHESIONS TOOK APPROXIMATELY 45 MINUTES AND WAS A SIGNIFICANT PORTION OF THE OPERATIVE TIME. THE DISCHARGE SUMMARY STATES THAT THE PATIENT HAD POSTOPERATIVE MILD CONGES

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)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT IN THE IMMEDIATE DAYS FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SYMPTOMS OF SEVERE ABDOMINAL PAIN AND EXTREME DISTENSION OF ABDOMEN, TROUBLE STANDING OR WALKING, DIFFICULTY BREATHING, LACK OF BOWEL MOVEMENTS AND FLATUS, AND BLACK FOUL SMELLING EMESIS. THE LEGAL COMPLAINT ALSO INDICATED THAT ON (B)(6) 2010, THE PATIENT WAS TRANSPORTED TO A HOSPITAL VIA AMBULANCE AND ADMITTED FOR SEVERE ABDOMINAL SEPSIS AND INFLAMMATION OF THE ABDOMEN AND ABDOMINAL TISSUE. IN ADDITION, THE PATIENT WAS OPERATED ON IMMEDIATELY AFTER ADMITTANCE TO THE HOSPITAL. ACCORDING TO THE LEGAL COMPLAINT, DURING THE OPERATION, DOCTORS OBSERVED THE PATIENT WAS SEPTIC AND HAD A PUNCTURED COLON. THE PATIENT WAS KEPT IN THE INTENSIVE CARE UNIT (ICU) IN SEVERE CRITICAL CONDITION MAINTAINED BY A VENTILATOR, SO THAT THE DOCTORS COULD CONTINUE TO TREAT HER. ALSO, THE LEGAL COMPLAINT INDICATED THAT DESPITE INVASIVE MEDICAL PROCEDURES EVERY TWO DAYS OVER THE DURATION OF TWO WEEKS IN ATTEMPT TO TREAT THE PATIENT, THE SEPSIS WAS

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 ALLEGED THAT DURING A DA VINCI S PARTIAL NEPHRECTOMY PROCEDURE AT (B)(6) HOSPITAL, THE PATIENT SUSTAINED CUTS AND LACERATIONS, CAUSING INJURY TO THE AORTA, LEFT RENAL ARTERY, SPLENIC VEIN AND PROXIMAL RENAL VEIN. IT IS ALSO ALLEGED THAT DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED PERFORATION OF THE PANCREAS. THE SURGEON DECIDED TO CONVERT THE PARTIAL NEPHRECTOMY PROCEDURE TO A RADICAL NEPHRECTOMY PROCEDURE. A SPECIALIST WAS CALLED IN TO ASSIST WITH IDENTIFICATION AND REPAIR OF THE DAMAGE ORGANS AND VESSELS. IT IS ALLEGED THAT BETWEEN (B)(6) 2010 AS RESULTS OF THE VARIOUS INJURIES AND IN PARTICULAR THE UNREPAIRED AND UNTREATED INJURY TO THE PANCREAS, HEMORRHAGIC DEBRIS AND FLUID ACCUMULATED IN THE CONTIGUOUS RESIDUAL CAVITY, CAUSING AND/OR CONTRIBUTING TO THE DEVELOPMENT OF A RIGHT PLEURAL EFFUSION AND PERICARDIAL EFFUSION. ON SEPTEMBER 28TH, 2012, ISI BECAME AWARE THAT THE PATIENT EXPIRED ON (B)(6) 2010.

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 GASTRECTOMY PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON NOTICED THAT THE PATIENT'S PANCREAS WAS DAMAGED. THE SURGEON REPAIRED THE DAMAGED PANCREAS AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO SYSTEM MALFUNCTIONS. POST-OPERATIVELY, THERE WAS OCCLUSION OF THE PATIENT'S SUPERIOR MESENTERIC ARTERY AND NECROSIS OF THE COLON OCCURRED. ON (B)(6) 2010, THE PATIENT UNDERWENT ANOTHER SURGICAL PROCEDURE TO RESECT HIS BOWEL. NECROTIZING FASCIITIS OCCURRED AFTER THE SURGERY AND THE PATIENT PASSED AWAY ON (B)(6) 2010, DUE TO MULTI-ORGAN FAILURE.

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 SI SACROCOLPOPEXY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO TO HAVE ILEUS. SEVERAL PROCEDURES WERE PERFORMED; HOWEVER, THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

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 PROSTATECTOMY FOR BENIGN PROSTATIC HYPERPLASIA ON AN UNSPECIFIED DATE IN (B)(6) 2010. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT HAD SURGERY IN (B)(6) OF 2010. AFTER HE HAD SURGERY, HE HAD TO BE RUSHED BACK TO THE HOSPITAL BECAUSE URINE BACKED UP IN HIS SYSTEM. HOWEVER, ON THE WAY TO THE HOSPITAL, HE PASSED AWAY IN THE CAR. ISI WAS PROVIDED WITH THE OPERATIVE REPORT WITH A PROCEDURE DATE OF (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PATIENT WAS FOUND TO HAVE A PROSTATE EXCEEDING 100 ML IN SIZE. THE ESTIMATED BLOOD LOSS OF THE SURGICAL PROCEDURE WAS 250 ML. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT WAS AWOKEN AT THE CONCLUSION OF THE SURGICAL PROCEDURE, EXTUBATED IN THE OPERATING ROOM AND TRANSPORTED TO RECOVERY IN EXCELLENT CONDITION, HAVING TOLERATED THE PROCEDURE WELL. POST-OPERATIVELY ON (B)(6) 2010, A VQ SCAN (VENTILATION-PERFUSION SCAN) WAS OBTAINED AFTER CONSULTATION WITH A PULMONOLOGIST. THE VQ SCAN WAS POSITIVE, HEPARIN WAS ADMINISTERED, AND THE

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 SUCCESSFUL DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED AN INFECTION AND WAS NOT DISCHARGED AS PLANNED. TEN DAYS POST OP, THE PATIENT WAS GIVEN A BLOOD THINNER AND EXPIRED DUE TO AN ARTERIAL BLEED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM.

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)(4) 2012 ISI RECEIVED A LEGAL SUMMONS AND COMPLAINT INDICATING ON (B)(6) 2010, THE PATIENT UNDERWENT A DA VINCI S PARTIAL NEPHRECTOMY PROCEDURE AT (B)(6) MEDICAL CENTER. DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED PERFORATION OF THE DUODENUM. BETWEEN (B)(6) 2010, THE PATIENT DEVELOPED AN ABSCESS, INFECTION AND SEPSIS. THE PATIENT DECEASED ON (B)(6) 2010.

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 CARDIAC PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGED THAT THE PATIENT'S MAIN ARTERY WAS CUT DURING SURGERY AND SHE BLED TO DEATH. THE DATE OF THE PATIENT'S DEATH WAS NOT PROVIDED. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY.

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 1 TO 2 HOURS DURING A DA VINCI SI COLECTOMY / ABDOMINOPERINEAL RESECTION PROCEDURE, THE PATIENT BEGAN TO ABNORMALLY BLEED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGERY. NO PATIENT HARM WAS REPORTED. TWO DAYS POST THE DA VINCI SI PROCEDURE, THE PATIENT EXPIRED. NO ADDITIONAL 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 POST A SUCCESSFUL DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

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 RADICAL CYSTECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION INCLUDING EXTERNAL ILIAC, INTERNAL ILIAC AND OBTURATOR NODES, AND ILEAL CONDUIT CREATION FOR BACILLUS CALMETTE-GUERIN (BCG) REFRACTORY INVASIVE BLADDER CANCER ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGES, PT HAD BLADDER REMOVED AND THEY BELIEVED THE SURGERY WENT WELL. PT BECAME ILL ON THE EVENING OF THE SURGERY AND WAS MOVED TO ICU. PT'S COLON WAS NICKED AND PT DIED 6 DAYS LATER. ISI WAS PROVIDED WITH THE OPERATIVE (OP) REPORT OF THE DA VINCI RADICAL CYSTECTOMY PROCEDURE. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. AFTER COMPLETION OF THE ROBOTIC PORTION OF THE SURGERY, THE ROBOT WAS UNDOCKED. ISI WAS ALSO PROVIDED THE OP REPORT FOR THE SURGICAL PROCEDURE THAT IMMEDIATELY FOLLOWED THE ROBOTIC PORTION OF THE SURGERY. THE OP REPORT WAS FOR AN ILEAL CONDUIT URINARY DIVERSION AND URETEROILEAL REIMPLANTATION FOR BLADDER CANCER, MUSCLE-INVASI

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), 2010 (B)(6), RISK MANAGER AT (B)(6) HOSPITAL, SUBMITTED A LETTER AFTER REVIEWING MEDWATCH MANUFACTURER REPORT NUMBER 2955842-2010-00306 STATING: AT NO TIME DURING THE LAPAROSCOPIC PROCEDURE DID THE DA VINCI SI SURGEON SIDE CONSOLE EXPERIENCE A LOSS OF POWER WHILE IN USE NOR WAS THE AORTA NICKED AS INDICATED IN THE MEDWATCH REPORT. ALTHOUGH A CALL WAS PLACED BY OPERATING ROOM PERSONNEL TO AN INTUITIVE SURGICAL TECHNICAL SUPPORT FIELD ENGINEER ON (B)(6), THIS CALL WAS PLACED AFTER THE PROCEDURE CONCLUDED. IT WAS NOTED DURING A CHECK OF THE EQUIPMENT AFTER THE PROCEDURE THAT THE SURGICAL SIDE CONSOLE WOULD NOT POWER ON. IT IS MY UNDERSTANDING THAT DURING THE TROUBLESHOOTING CONVERSATION BETWEEN THE OPERATING ROOM PERSONNEL AND THE TECHNICAL SUPPORT FIELD ENGINEER THAT IT WAS REPORTED TO THE TECHNICAL SUPPORT FIELD ENGINEER THAT A DEFIBRILLATOR HAD BEEN PLUGGED INTO THE SAME ELECTRICAL WALL SOCKET AS THE SURGICAL SIDE CONSOLE AND THAT THE DEFIBRILLATOR HAD BEEN ACTIVATED. PLEASE BE ADVICED THAT THE DEFIBRILLATOR WAS NOT ACTIVATED DURING THE DA VINCI 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: THE PT COMPLAINED ABOUT INABILITY FOR LONGER EXERCISING DURING A FOLLOW-UP. IN VIEW OF PHYSICIAN, THE PT FOLLOW-UP DATA REVEALED THAT, DURING RECORDED PT EXERCISE EPISODE, THE DEVICE SWITCHED TO AN INADEQUATE PACING MODE.

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 THE ROBOTIC PORTION OF A COLON RESECTION WAS SUCCESSFULLY PERFORMED, THE PATIENT SUFFERED A HEART ATTACK WHILE THE SURGEONS WERE CLOSING THE PATIENT USING STANDARD MEDICAL PROCEDURE. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND EXPIRED ON THE TABLE.

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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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