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 HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY FOR ABNORMAL UTERINE BLEEDING, MENORRHAGIA, UTERINE HYPERTROPHY, UTERINE FIBROIDS, AND COMPLEX ENDOMETRIAL HYPERPLASIA WITH ATYPICAL ON (B)(6) 2011. ISI WAS PROVIDED WITH THE PATIENT OPERATIVE (OP) REPORT PERTAINING TO HER DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, MEDICAL DOCUMENTATION PERTAINING HER PRE-SURGICAL CONDITION, AND CARDIAC CLEARANCE. ISI WAS ALSO PROVIDED MEDICAL DOCUMENTATION PERTAINING TO HER HOSPITALIZATION FROM (B)(6) 2011, THE DATE THE PATIENT DIED AND HER CERTIFICATE OF DEATH. THE PATIENT'S RECORDS HAVE BEEN EXTENSIVELY REVIEWED. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S OP REPORT FOR HER DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES; HOWEVER, IT WAS INDICATED THAT THE SURGERY WAS COMPROMISED BY THE PATIENT'S HABITUS AND HER EXTREME OBESITY, WHICH REQUIRED ADDITIONAL OPERATING TIME IN PRE-HYSTERECTOMY AND HYSTERECTOMY PORTIONS OF THE PROCEDURE. ON (B)(6) 2011,

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 SI BILATERAL SALPINGO-OOPHORECTOMY (BSO) WAS COMPLETED, THE PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY OR TWO DAYS POST PROCEDURE COMPLAINING OF PAIN. A GENERAL SURGEON SAW THE PATIENT AND MADE THE DECISION TO OPEN THE PATIENT FOR EXPLORATORY SURGERY WHICH RESULTED IN A DIAGNOSIS OF SEPSIS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED. THE PATIENT EXPIRED ON (B)(6) 2011. SINCE RECEIVING THIS INITIAL REPORT, THE SITE HAS BEEN CONTACTED TO REQUEST ADDITIONAL INFORMATION WITHOUT SUCCESS.

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 56 HOURS AFTER A DA VINCI SI TORS (TRANSORAL ROBOTIC SURGERY) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED HEAVY BLEEDING AND CARDIOPULMONARY ARREST ENSUED. CPR WAS PERFORMED IN EXCESS OF 20 MINUTES BEFORE THE PATIENT'S PULSE WAS RESTORED AND AS A RESULT, IRREVERSIBLE ANOXIC BRAIN INJURY OCCURRED. ON (B)(6) 2011, THE PATIENT EXPIRED. AT THE TIME OF THE REPORT, THE CAUSE OF THE PATIENT BLEEDING WAS UNDETERMINED. IT WAS ALSO REPORTED THAT DURING THE SURGICAL PROCEDURE, THERE WERE NO SYSTEM FAILURES, NO INJURY TO THE PATIENT, AND NO COMPLICATIONS EXPERIENCED.

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 45 MINUTES INTO A DA VINCI S OVARIAN CYSTECTOMY PROCEDURE, THE SURGEON ENCOUNTERED EXCESSIVE ADHESIONS WITHIN THE PATIENT'S ANATOMY WHICH MADE IT DIFFICULT TO PERFORM THE PROCEDURE LAPAROSCOPICALLY. AT THIS TIME, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN TECHNIQUES TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ISSUES NOTED. APPROXIMATELY TWO TO THREE WEEKS POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH ILEUS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED; HOWEVER, THE PATIENT EXPIRED AFTER BEING DIAGNOSED. THE SITE'S RISK MANAGEMENT DEPARTMENT HAS BEEN CONTACTED SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE DELAY IN REPORTING IS DUE TO AN ISI EMPLOYEE'S MISUNDERSTANDING OF COMPLAINT REPORTING CRITERIA. THE SITE ADVISED THAT THERE WAS NOT CORRELATION BETWEEN OUR SYSTEM AND THE EVENT AND OUR ISI REPRESENTATIVE UNDERSTOOD THE SITE'S FEEDBACK AS NOT REQUIRING THE INITIATION OF A COMPLAINT RECORD. SINCE THIS MISUNDERSTANDING WAS DISCOVERED, RETRAINING HAS BEEN PERFORMED WITH THE ISI REPRESENTATIVE TO MITIGATE FUTURE OCCURRENCES.

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) 2011 FOR LOWER ANTERIOR RESECTION FOR OBSTRUCTING RECTOSIGMOID CANCER WHO SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED BUT THEY ARE ALL RELATED TO SUBSEQUENT HOSPITALIZATIONS AND NON-ROBOTIC PROCEDURE. ULTIMATELY, THE PATIENT WAS FOUND TO HAVE EXPIRED AT HOME BY HIS SPOUSE ON (B)(6) 2011 AND AN AUTOPSY REPORT WAS INCLUDED. 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 HOSPITAL AUTOPSY'S CLINICAL SUMMARY PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN IN RELATIVELY GOOD HEALTH UNTIL (B)(6) 2011 AT WHICH TIME HE PRESENTED WITH MULTIPLE SYMPTOMS THAT INCLUDED GASTROINTESTINAL BLEEDING, ANEMIA, HYPONATREMIA, HYPERGLYCEMIA, AND FEBRILE ILLNESS. DURING HIS WORKUP, HE WAS ULTIMATELY FOUND TO HAVE NEARLY OBSTRUCTING RECTOSIGMOID MASS, AND UNDERWENT ROBOTIC LOW ANTERIOR RESECTION ON (B)(6) 2011, WITH SPLENIC

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 ON (B)(6), 2011 A PATIENT PASSED AWAY 18 MONTHS AFTER A DA VINCI S PROCEDURE TO REMOVE THE LOWER LOBE OF THEIR LEFT LUNG DUE TO BRONCHIOLOALVEOLAR CARCINOMA. ACCORDING TO THE PATIENT'S HUSBAND, DURING THE PROCEDURE, THE PATIENT'S STOMACH AND DIAPHRAGM WERE PUNCTURED RESULTING IN SEPSIS. THE PATIENT UNDERWENT A 5 MONTH HOSPITAL STAY AND EIGHTEEN MONTHS AS A NEAR INVALID. TO DATE, (B)(6) HAS NOT PROVIDED THE PATIENT'S HUSBAND WITH INFORMATION REGARDING THIS EVENT. INTUITIVE HAS CONTACTED THE SITES RISK MANAGEMENT DEPARTMENT, WHO ADVISED THAT THEY WOULD INVESTIGATE THIS EVENT AND RESPOND BACK TO INTUITIVE WITHIN THE UPCOMING WEEKS.

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 APRIL 4, 2012 INTUITIVE SURGICAL WAS CONTACTED BY THE PATIENT'S GRAND-DAUGHTER THAT THE PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM ON (B)(6) 2011. REPORTEDLY, DURING THE BIOPSY PROCEDURE, THE PATIENT'S RENAL ARTERY WAS DAMAGED. THE PLANNED PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO REPAIR THE AFFECTED VESSEL AND THE PATIENT REQUIRED A PARTIAL NEPHRECTOMY AS A RESULT OF THE DAMAGE. THE PATIENT LOST 13 PINTS OF BLOOD. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO PNEUMONIA, MULTIPLE ORGAN FAILURE AND RENAL 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 AFTER A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE PATIENTS BLOOD PRESSURE HAD DROPPED, THE SURGEON PERFORMED A MINI THORACOTOMY TO IDENTIFY THE SOURSE OF THE BLOOD PRESSURE LOSS. A LEAK IN THE MITRAL VALVE WAS FOUND AND A STERNOTOMY WAS PERFORMED TO REPAIR OF THE VALVE; HOWEVER, THE PATIENT EXPIRED BEFORE THE VALVE COULD BE REPAIRED. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION RELATED TO THIS EVENT; HOWEVER, NO NEW INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

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 EIGHT DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED DUE TO UNCONTROLLABLE POST OPERATIVE BLEEDING.

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 SI HYSTERECTOMY PROCEDURE THE PATIENT SUFFERED A PERIOPERATIVE LEFT HEMISPHERE CEREBROVASCULAR ACCIDENT (CVA) SECONDARY TO COMPLETE OCCLUSION OF LEFT CAROTID ARTERY (EMBOLIC). POSTOPERATIVELY NOTED TO BE COMPLETELY APHAGIC AND RIGHT HEMIPLEGIC. A CLOT WAS IDENTIFIED VIA MRA IMAGING FROM BIFURCATION OF AORTA. NO H/O HYPERCOAGULABILITY. FIBROMUSCULAR HYPERPLASIA (FMH) SIGNIFICANT FOR MOTHER SUFFERING FATAL CEREBROVASCULAR ACCIDENT (CVA). 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-ASSISTED ROBOTIC PROCEDURE - SMALL BOWEL RESECTION FOR FOREIGN BODY (CAMERA) OF SMALL BOWEL, POSSIBLE INFLAMMATORY MASS ON (B)(6) 2011. PER THE MEDICAL RECORDS, THE PATIENT HAD PERSISTENT ANEMIA, HAD HAD NEGATIVE WORKUP, AND THEN UNDERWENT INGESTION OF A VIDEOCAMERA IN (B)(6) 2009, BUT WAS UNABLE TO PASS THE CAMERA. AFTER SEVERAL ATTEMPTS AT THIS, SHE ELECTED TO HAVE OPERATIVE INTERVENTION. ADDITIONAL RECORDS STATE THAT THE PATIENT WAS UNABLE TO PASS THE CAPSULE AND WAS FOUND TO HAVE A SMALL AREA OF ULCERATION AND FIBROSIS. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND OTHER MEDICAL 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 THE OPERATION. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PERTINENT FINDINGS INCLUDE MULTIPLE AREAS OF THICKENED MESENTERY. THE SURGEON'S DICTATED OPERATIVE REPORT STATES, NEAR THE ILEOJEJUNAL JUNCTION, THERE WAS AN AREA OF SMALL BOWEL THAT HAD THICKENED MESENTERY AND FELT 2 OR 3 AREAS

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 10 DAYS AFTER A DA VINCI SI TRANSORAL RESECTION PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED BLEEDING IN THE SURGICAL AREA AND EXPIRED. THE DATE OF THE SURGICAL PROCEDURE AND DATE OF DEATH WERE NOT RECEIVED. PRE SURGERY, THE PATIENT'S CANCER WAS THOUGHT TO BE AT STAGE T2, HOWEVER, DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE CANCER WAS AT STAGE T3. THERE WERE NO SYSTEM MALFUNCTIONS DURING THE PROCEDURE AND THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM. THE SURGEON BELIEVES THAT THE POST SURGICAL BLEEDING MAY HAVE BEEN RELATED TO A DELAY IN HEALING AND THAT A SCAB MAY HAVE COME OFF. THE DELAY IN REPORTING IS DUE TO A MISUNDERSTANDING ABOUT WHEN INTUITIVE SURGICAL FIRST BECAME AWARE OF THE EVENT.

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 WHILE REMOVING TISSUE DURING A DA VINCI S TRANSORAL RESECTION PROCEDURE PERFORMED ON (B)(6) 2010, THE SURGEON ENCOUNTERED AN UNUSUAL GROUP OF VEINS AND PATIENT BLEEDING OCCURRED. THE SURGEON WAS ABLE TO STOP THE BLEEDING AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WERE NO SYSTEM MALFUNCTIONS DURING THE PROCEDURE. FIVE DAYS POST-OP, THE PATIENT EXPERIENCED BLEEDING AND 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT AN ATTEMPTED DA VINCI-ASSISTED ROBOTIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND ABDOMINAL COMPLETION OF HYSTERECTOMY FOR ATYPICAL ENDOMETRIAL HYPERPLASIA ON (B)(6) 2010. THE PATIENT ALSO UNDERWENT SEROMUSCULAR REPAIR OF THE BLADDER AND SEROMUSCULAR REPAIR OF THE SIGMOID COLON. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, OTHER MEDICAL RECORDS, AND A DEATH CERTIFICATE. ACCORDING TO THE OPERATIVE REPORT, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR ACCESSORY. PERTINENT FINDINGS INCLUDED: THE PATIENT WAS NOTED TO HAVE DENSE ADHESIONS OF THE BLADDER TO THE ANTERIOR UTERUS AND ANTERIOR CERVIX. THE OPERATIVE REPORT ALSO STATES, THE PATIENT HAD THE PROCEDURE INITIALLY STARTED ROBOTICALLY, DESPITE MULTIPLE ATTEMPTS TO TRY AND SWEEP THE BOWEL OUT OF THE PELVIS, IT WAS DIFFICULT KEEPING THE SIGMOID COLON AND TO A LESSER DEGREE THE CECUM AND SMALL BOWEL AWAY FROM THE SURGICAL FIELD. DURING MOBILIZATION AND DISSECTION OF THE BLADDER, THE SURGEON NOTED, I WAS USING THE THIRD ARM OF THE ROBOT TO KEEP TRACTION UP ON THE BLADD

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.