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 COMPLETION OF A DA VINCI RIGHT HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 7. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE PATIENT BEGAN TO REFUSE HIS MEDICATIONS AND HAD PULLED OUT HIS NG TUBE PRIOR TO PASSING AWAY. SHE ALSO INDICATED THAT POSSIBLY THE PATIENT ASPIRATED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, HE WAS PRESENT DURING PARTS OF THE DA VINCI SURGICAL PROCEDURE. DURING THE TIMES THAT HE WAS PRESENT, THE CSR INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED. THE CSR STATED THAT AN INITIAL AUTOPSY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE DEVELOPED ILEUS. IN ADDITION, THE PATIENT'S STAPLE LINE HAD RUPTURED. ON (B)(4) 2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED. THE RISK MANAGER STATED THAT BASED ON THE OPERATIVE REPORT AND THE SITE'S PREL

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 SINGLE-SITE CHOLECYSTECTOMY, THE SURGEON INADVERTENTLY CUT THE PATIENT'S COMMON BILE DUCT WHILE LIGATING AND CUTTING THE PATIENT'S CYSTIC DUCT WITH THE MONOPOLAR HOOK INSTRUMENT. THERE WAS NO ALLEGATION THAT THE MONOPOLAR HOOK INSTRUMENT MALFUNCTIONED DURING THE EVENT. THE SURGEON THEN MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY. THE SURGEON WAS ABLE TO REPAIR THE COMMON BILE DUCT AND THE CHOLECYSTECTOMY PROCEDURE WAS COMPLETED VIA OPEN SURGERY. THE PATIENT REMAINED HOSPITALIZED FOR 3-4 DAYS AND WAS IN STABLE CONDITION UPON DISCHARGE. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, HE WAS INFORMED THAT THE PATIENT WAS FOUND DECEASED IN HER HOME. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER INDICATED THAT THE CASE IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE AND UNWILLING TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED 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 DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES. HOWEVER, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE CONVERSION TO OPEN SURGERY WAS UNRELATED TO ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM. SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. HOWEVER, THE INITIAL REPORTER WAS INFORMED THAT THE ROBOTIC PART OF THE PROCEDURE HAD ALREADY BEEN COMPLETED BY THE TIME THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY. SHE INDICATED THAT THE SURGICAL PROCEDURE WAS COMPLETED ALTHOUGH THE PATIENT WAS NOT DOING WELL POST-OPERATIVELY. ON (B)(6) 2014, THE INITIAL REPORTER WAS NOTIFIED BY THE SITE THAT THE PATIENT HAD PASSED AWAY. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON WAS AWARE THAT THE DA VINCI NEPHRECTOMY WAS GOING TO BE DIFFICULT EVEN BEFORE THE PROCEDURE BEGAN. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY DUE TO THE SIZE AND LOCATION OF THE PATIENT'S TUMOR

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 UNDERGOING A DA VINCI INCISIONAL HERNIA REPAIR PROCEDURE, THE PATIENT PASSED AWAY. THE INITIAL REPORTER OF THIS COMPLAINT, A RESIDENT, DID NOT KNOW THE DATE OF THE DA VINCI SURGICAL PROCEDURE AND WHAT DATE THE PATIENT PASSED AWAY. THE INITIAL REPORTER EXPLAINED THAT HE WAS INFORMED OF THE PATIENT DEATH BY ANOTHER RESIDENT. THE INITIAL REPORTER DID NOT HAVE THE RESIDENT'S CONTACT INFORMATION.

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 COMPLETION OF A DA VINCI HEMICOLECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT SHE WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE AND THE SURGEON PERFORMED EXTRA CAUTERIZATION ON THE PATIENT'S COLON USING A LAPAROSCOPIC STAPLER INSTRUMENT. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT SHE WAS PRESENT DURING THE FIRST HALF OF THE DA VINCI SURGICAL PROCEDURE AND THE CASE WENT WELL. ON POST-OPERATIVE DAY 1, THE PATIENT PRESENTED WITH SYMPTOMS OF AN ANASTOMOTIC LEAK. AT AN UNSPECIFIED TIME THAT SAME DAY, THE PATIENT CODED AND WAS THEN STABILIZED. LATER, THAT SAME DAY, THE PATIENT CODED AGAIN AND THEN SUBSEQUENTLY PASSED AWAY. THE INITIAL REPORTER STATED THAT THE SURGEON DID NOT USE A STAPLER INSTRUMENT MANUFACTURED BY ISI. SHE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE INITIAL REPORTER SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT AND WAS INFORMED THAT TH

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 PROSTATECTOMY PROCEDURE, DURING THE PATIENT'S HOSPITAL RECOVERY, IT WAS DISCOVERED THAT THE PATIENT HAD A BOWEL INJURY. THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR REPAIR OF THE BOWEL DEFECT; HOWEVER, THE PATIENT EXPIRED. ACCORDING TO THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT, SHE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE AND THAT SHE WAS MADE AWARE OF THE REPORTED INCIDENT BY THE SITE'S GENERAL SURGEON. SHE WAS UNABLE TO PROVIDE ANY OTHER INFORMATION REGARDING THE REPORTED 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 A PATIENT UNDERWENT A DA VINCI LOBECTOMY PROCEDURE AND THE CASE WAS CONVERTED TO OPEN DUE TO BLEEDING. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) SPOKE TO THE SURGEON AND WAS INFORMED THAT THE PATIENT DID NOT TOLERATE THE PROCEDURE WELL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT 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: KIDNEY CYST RESECTION WITH DA VINCI ROBOTIC DEVICE AT VIA (B)(6). SURGEON INADVERTENTLY AVULSED A VEIN OR ARTERY WHICH CAUSED MASSIVE BLEED AND PRESSURE DROPS. SURGEON BEGAN USING THE ROBOT'S STAPLING DEVICE TO CONTROL THE BLEED. DURING ONE OF THOSE ATTEMPTS, A STAPLE WAS INADVERTENTLY PLACED ACROSS THE PATIENT'S ABDOMINAL AORTA. UNFORTUNATELY THIS WAS NOT DISCOVERED UNTIL AFTER THE SURGERY SEVERAL HOURS LATER. ONCE IT WAS DETERMINED THAT THE PATIENT HAD NO BLOOD FLOW BELOW HER ABDOMINAL AORTA, SHE WAS TAKEN BACK TO SURGERY WITH A VASCULAR SURGEON. THAT SURGEON REMOVED THE STAPLED PART OF THE AORTA AND CREATED A BYPASS. UNFORTUNATELY THE PATIENT HAD RECEIVED SO MANY UNITS OF BLOOD SHE WAS UNABLE TO CLOT AND DEVELOPED A COAGULOPATHY WHICH LED TO HER DEATH ON THE SURGERY 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 DURING A DA VINCI PARTIAL NEPHRECTOMY PROCEDURE, THE SURGEON ENCOUNTERED HEAVY BLEEDING FROM THE PATIENT AND DUE TO THE EXTENSIVE BLEEDING EXPERIENCED BY THE PATIENT THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. LATER THAT NIGHT, THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM (OR) AND A VASCULAR SURGEON WAS CONSULTED. ACCORDING TO THE SURGEON IT IS THE HOSPITAL'S BELIEF THAT THE PATIENT'S AORTA HAD BEEN NEARLY STAPLED ACROSS. THE PATIENT EXPIRED IN THE OR. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT REGARDING THE REPORTED EVENT. ACCORDING TO THE SITE'S RISK MANAGER, THE HOSPITAL'S INVESTIGATION IS ONGOING; HOWEVER, THEIR INVESTIGATION THUS FAR HAS DETERMINED THAT THE INTRA-OPERATIVE BLEEDING EXPERIENCED BY THE PATIENT AND FINAL PATIENT OUTCOME WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE RISK MANAGER INDICATED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES DURING THE PLANNED SURGICAL PROCEDURE. THE RISK MANAGER INDICATED THAT HE WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO ALLEGEDLY SUSTAINED AN INJURY DURING A DA VINCI HYSTERECTOMY AT AN UNSPECIFIED HOSPITAL AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE. NO OTHER INFORMATION REGARDING THE REPORTED ALLEGATION 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 WHO UNDERWENT A DA VINCI-ASSISTED EXTRA FASCIAL HYSTERECTOMY AND RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2014 FOR UNSTAGED ADENOCARCINOMA OF THE ENDOMETRIUM. DURING THE SAME PROCEDURE, THE PATIENT ALSO UNDERWENT A DIAGNOSTIC LAPAROSCOPY, WASHINGS, LYSIS OF ADHESIONS, AND PELVIC SENTINEL LYMPH NODE REMOVAL. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT IN ADDITION TO PATIENT MEDICAL AND LEGAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A LEGAL DOCUMENT PROVIDED CLAIMS THAT THE SURGEONS CUT, NICKED, TORE, BURNED OR OTHERWISE DISRUPTED THE SIGMOID COLON IN ONE OR MORE LOCATIONS. IN ADDITION, THE LEGAL DOCUMENT NOTES, IN AN ATTEMPT TO REPAIR ONE OF THE INJURIES TO THE SIGMOID COLON, THE SURGEONS PLACED SUTURES. PER THE DA VINCI OPERATIVE REPORT, OPERATIVE FINDINGS INCLUDED THE FOLLOWING: THE LAPAROSCOPY REVEALED SOME PERIHEPATIC ADHESIONS. SHE HAD SOME ADHESIONS IN THE PELVIC AREA IN THE SITE OF HER PREVIOUS SURGERY. BIOPSY FROM THIS AREA SHOWED GRANULATION TISSUE WITH NO OBVIOUS M

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 THE FIRST HOUR OF THE DA VINCI ADRENALECTOMY PROCEDURE, THE SURGEON NICKED A BRANCH OF A RENAL VEIN. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY USING A MARYLAND BIPOLAR FORCEPS INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) 2. THE SURGEON THEN MADE THE DECISION TO CONVERT THE DA VINCI ADRENALECTOMY PROCEDURE TO OPEN SURGICAL TECHNIQUES IN ORDER TO SUTURE THE VESSEL. AT AN UNSPECIFIED TIME DURING THE REMAINDER OF THE OPEN SURGICAL PROCEDURE, THE PATIENT'S VENA CAVA WAS INJURED. THE PATIENT WAS THEN TRANSPORTED TO ANOTHER FACILITY AND SUBSEQUENTLY PASSED AWAY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON INDICATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER WAS PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT'S RENAL ARTERY WAS NICKED BY THE SURGEON. HOWEVER, SHE STATED THAT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUM

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 HAD DIED AFTER UNDERGOING A DA VINCI LUNG LOBECTOMY PROCEDURE ON (B)(6) 2014. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WAS PRESENT DURING MOST OF THE DA VINCI PROCEDURE AND CLAIMS THAT THERE WAS NO REPORTED SYSTEM MALFUNCTION THAT OCCURRED DURING THE PROCEDURE. THE CSR WAS INFORMED ON (B)(4) 2014 BY THE SURGEON THAT THE PATIENT HAD DIED. THE SURGEON TOLD THE CSR THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DA VINCI SYSTEM. PER THE CSR, THIS PATIENT HAD BEEN ALREADY TREATED WITH RADIOTHERAPY. NO FURTHER CLINICAL INFORMATION WAS PROVIDED TO ISI ABOUT THIS CASE.

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 COMPLETION OF A DA VINCI MITRAL VALVE REPAIR WITH MAZE PROCEDURE, WHEN THE SURGEON WENT TO CLAMP THE PATIENT, HE OBSERVED THAT THE PATIENT HAD AN AORTIC DISSECTION. AS A RESULT THE SURGEON CONVERTED THE PROCEDURE TO AN OPEN STERNOTOMY. APPROXIMATELY 2 HOURS INTO THE OPEN PROCEDURE IT WAS DISCOVERED THAT THE PATIENT'S LEFT VENTRICLE WAS NOT FUNCTIONING AND AN ATTEMPT WAS MADE TO RESUSCITATE THE PATIENT'S LEFT VENTRICLE. REPORTEDLY, THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). APPROXIMATELY 2 DAYS LATER A CT SCAN PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT HAD NO BRAIN ACTIVITY AND LATER THAT SAME DAY THE PATIENT EXPIRED. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, SHE WAS PRESENT DURING THE SURGICAL PROCEDURE. REPORTEDLY, THE PATIENT WAS NEVER TAKEN OFF BYPASS WHEN THE INCIDENT OCCURRED. ON (B)(4) 2014, THE CSR SPOKE TO THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS DUE TO T

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 GASTROSTOMY PROCEDURE, APPROXIMATELY 1.5 DAYS AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL; THE PATIENT DEVELOPED A PULMONARY EMBOLISM AND SUBSEQUENTLY EXPIRED. ON (B)(6) 2014, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) WHO REPORTED THIS COMPLAINT REPORTED THAT SHE WAS PRESENT AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE. ACCORDING TO THE CSR SHE WAS TOLD BY THE SITE'S ROBOTICS COORDINATOR THAT THE PATIENT WAS VERY SICK PRIOR TO UNDERGOING THE ROBOTIC PROCEDURE AND THAT DURING THE SURGICAL PROCEDURE, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE ROBOTICS COORDINATOR ALSO INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. THE PATIENT'S SPECIFIC PRE-EXISTING CONDITIONS WERE NOT PROVIDED TO THE CSR. 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT EXPIRED. THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE PATIENT HAD A HISTORY OF DRUG ABUSE, BLOOD PRESSURE ISSUES, AND WAS OBESE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER. THE INITIAL REPORTER WAS NOT PRESENT DURING THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POST-OPERATIVE DAY 1. THE PATIENT REPORTEDLY PASSED AWAY THE FOLLOWING DAY ON POST-OPERATIVE DAY 2. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO THE SURGEON REGARDING THE REPORTED EVENT AND THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE DA VINCI HYSTERECTOMY PROCEDURE. ALSO, THERE WERE NO REPORTS THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED. ON (B)(6) 2014, THE INITIAL REPORTER SPOKE TO THE SURGEON AND WAS INFORMED THAT THE AUTOPSY REPORT WAS STILL NOT COMPLETED AT THE TIME. ON (B)(6) 2014, ISI CONTACTED THE SITE'S OR DIRECTOR. SHE STATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROC

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 COMPLETION OF A DA VINCI URETERAL REIMPLANTATION PROCEDURE, THE PATIENT DEVELOPED SEPSIS ROUGHLY AROUND POST-OPERATIVE DAY 2. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND THE PATIENT WAS FOUND TO HAVE SUSTAINED A PERFORATED COLON. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. ACCORDING TO THE ROBOTICS COORDINATOR FROM THE SITE, AN INTERNAL INVESTIGATION WAS BEING PERFORMED IN RELATION TO THE REPORTED EVENT. THE CAUSE OF THE PATIENT'S BOWEL PERFORATION WAS UNKNOWN. HOWEVER, THE ROBOTICS COORDINATOR INDICATED THAT THE SITE BELIEVES THE BOWEL INJURY MIGHT HAVE OCCURRED DURING INTRODUCTION OF A CAMERA PORT. REPORTEDLY, THE CAMERA PORT WAS NOT CREATED UNDER DIRECT VISUALIZATION. ON (B)(6) 2014, ISI CONTACTED THE ROBOTICS COORDINATOR AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. TO HER KNOWLEDGE, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. SHE REITERATED THAT THE SITE BELIEVES THE CAUSE OF THE PATIENT'S INJURY WAS DUE TO CAMERA TROCAR INSERTION.

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 COMPLETION OF A DA VINCI SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT EXPIRED ON POST-OPERATIVE DAY 2. NO ISSUES WERE REPORTED TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE PATIENT'S MEDICAL RECORDS AND THE OPERATIVE REPORT. ACCORDING TO THE RISK MANAGER, THE PATIENT HAD A HISTORY OF CARDIAC DISEASE AND CORONARY ARTERY DISEASE. HE WAS A 2 PACK/DAY SMOKER. ON (B)(6) 2014, THE PATIENT WAS SEEN IN THE HOSPITAL FOR COMPLAINTS OF ABDOMINAL PAIN AND CHEST PAIN. IMAGING WAS PERFORMED AND IT WAS DETERMINED AT THE TIME THAT THE PATIENT NEEDED A CHOLECYSTECTOMY. THE PATIENT REPORTEDLY TOLD THE SURGEON THAT HE HAD KNOWN THAT HE HAD GALL STONES FOR 3 YEARS. BASED ON THE OPERATIVE REPORT, THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR MALFUNCTIONS OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY. THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POST-OPERATIVE DAY 1 ((B)(6) 2014). THE RISK MANAGER INDICATED THAT AT THE TIME OF DISCHARGE, THE PA

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 SURGICAL PROCEDURE ON AN UNSPECIFIED DATE IN 2010. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY PATIENT MEDICAL RECORDS. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER THE LEGAL DOCUMENT, THE PATIENT SUFFERED INTERNAL BLEEDING DURING SURGERY. PATIENT WAS IN A COMA FOR 2 WEEKS AND THEN DIED.

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 PROSTATECTOMY PROCEDURE AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. THE DA VINCI SERIAL OR MODEL IS UNKNOWN. IN (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI ROBOTIC-ASSISTED PROSTATECTOMY FOR UNKNOWN REASON. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: PER ROBOTIC SURGERY CLAIM FORM, THE PATIENT HAD SURGERY IN (B)(6) 2012 AND PASSED AWAY (B)(6) 2012. HE SUSTAINED A STROKE AND KNICKED BLADDER. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION.

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 PROCEDURE ON (B)(6) 2011 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2011. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ACCORDING TO THE MEDIATION COVER SHEET, ON (B)(6) 2011, THE PATIENT HAD A PROSTATECTOMY PROCEDURE. THE PATIENT'S ABDOMEN BECAME DISTENDED; CT REVEALED URINE POOLING IN ABDOMEN; ER SURGERY TO REPAIR TORN BLADDER; PASSED AWAY AFTER COMPLICATIONS FROM SUBSEQUENT SURGERY 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 POST A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PARA AORTIC NODE DISSECTION PROCEDURE PERFORMED ON (B)(6) 2014 THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE DUE TO INFARCTION OF THE RIGHT COLON. THE DATE OF THE PATIENT'S DEMISE WAS NOT REPORTED AND IT IS THE SURGEON'S BELIEF THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THE PATIENT HAD UTERINE CANCER AND BOWEL ISCHEMIA. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES, BUT WAS CAUSED BY THE PATIENT'S BOWEL ISCHEMIA. DUE TO HIPPA REGULATIONS, THE SURGEON DECLINED TO PROVIDE ANY OTHER INFORMATION REGARDING THE PATIENT.

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 CHOLECYSTECTOMY ON (B)(6) 2014 AND SUSTAINED AN INTRA-OPERATIVE PERFORATION. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT PASSED AWAY ON (B)(6) 2014 DUE TO COMPLICATIONS OF BACTERIAL SEPSIS. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS.

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 COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND PARA-ESOPHAGEAL REPAIR PROCEDURE, THE PATIENT RETURNED TO THE ICU ON POST-OPERATIVE DAY 3. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. HOWEVER, THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2014. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. THE INITIAL REPORTER INDICATED THAT HE WAS PRESENT DURING THE SURGICAL PROCEDURE AND NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS OBSERVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT RETURNED TO THE HOSPITAL ON POST-OPERATIVE DAY 3 AND A PERFORATION OF HER STOMACH WAS FOUND. THE INJURY WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 8 DAYS LATER. THE DAY AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT PASSED AWAY. THE INITIAL REPORTER DID NOT KNOW THE CAUSE OF THE PATIENT'S DEMISE. HE STATED THAT THE PATIENT HAD COMPROMISED HEALTH PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE. NO ADDITIONAL INFORMATION

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 PROSTATECTOMY PROCEDURE, THE PATIENT LOST 3500 CC'S OF BLOOD. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE DA VINCI SURGICAL PROCEDURE TOOK 10 HOURS. THE PATIENT WAS TAKEN TO THE ICU AND THEN PASSED AWAY THE FOLLOWING DAY ON (B)(6) 2013. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S RISK MANAGER. THE RISK MANAGER INDICATED THAT THE SURGEON INVOLVED WITH THIS COMPLAINT WAS NO LONGER EMPLOYED BY THE SITE. ACCORDING TO THE RISK MANAGER, NO MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER STATED THAT AN AUTOPSY HAS BEEN PERFORMED AND THE CAUSE OF THE PATIENT'S DEATH WAS CARDIAC ARREST AND BLEEDING. THE RISK MANAGER INDICATED THAT THE SITE IS CURRENTLY REVIEWING THE CASE AND THE CAUSE OF THE INTRA-OPERATIVE BLEEDING IS UNDER INVESTIGATION. THE RISK MANAGER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE PATIENT OR REPORTED 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: ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) REPRESENTATIVE BECAME AWARE OF A PATIENT WHO PASSED AWAY 11 DAYS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE, HERNIA REPAIR, AND LAPARATOMY PROCEDURE. THE FOLLOWING INFORMATION WAS OBTAINED FROM THE SURGEON WHO PERFORMED THE DA VINCI SURGERY. ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI HYSTERECTOMY WITH NODES DISSECTION PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2013. THE PATIENT REPORTEDLY DID NOT SUSTAIN ANY BOWEL INJURIES DURING THE DA VINCI SURGERY. ON (B)(6) 2013, THE SURGEON WHO PERFORMED THE DA VINCI SURGERY PERFORMED A HERNIA REPAIR ON THE PATIENT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014 MORNING, THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN. SHE HAD AN UNSPECIFIED CT SCAN (RESULTS WERE NOT PROVIDED) AND AN ARTERIOGRAM (VESSELS WERE NORMAL). THE PATIENT UNDERWENT 2 CT SCANS AND LATER WENT INTO RENAL FAILURE AND BECAME SEPTIC THE SAME DAY. THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6) 2014 FOR A LAPAROTOMY, WHICH WAS WHEN THE INCARCERATED DISTAL ILEUM AND CECUM WERE IDENTIFIED. ON (B)(6) 2014 MIDNIGHT, THE PATIENT CODED AND WAS RESUSCITATED. A

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 DIED AFTER UNDERGOING A DA VINCI RIGHT UPPER LOBE WEDGE RESECTION PROCEDURE FOR A LUNG MASS ON (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENTS, IT WAS ALLEGED THAT DUE TO A DEFECTIVE DESIGN OF THE DA VINCI SURGICAL SYSTEM, THE PATIENT SUSTAINED AN ARTERY INJURY TO THE RIGHT INTERNAL JUGULAR VEIN. AS A RESULT, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND DETERIORATED TO ASYSTOLE, AND SUBSEQUENTLY PASSED AWAY AT THE END OF THE PROCEDURE. ISI RECEIVED THE PATIENT'S DA VINCI OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT WAS PREVIOUSLY TREATED WITH CHEMOTHERAPY AND RADIATION IN THE LEFT LOWER LOBE FOR STAGE III LUNG CANCER AND WAS PRESENTED WITH A NEW ENLARGING LESION IN THE UPPER MEDIASTINUM/RIGHT UPPER LOBE. AFTER THE DA VINCI SYSTEM WAS DOCKED TO THE PATIENT, THE PATIENT'S CHEST WAS EXPLORED AND NO METASTATIC TISSUE WAS FOUND. A MASS WAS IDENTIFIED IN THE RIGHT UPPER LOBE FIRMLY ADHERENT TO THE MEDIASTINUM, AT THE APEX OF THE CHEST, AT THE SUPERIOR MEDIASTINUM. THE PLEURA OVER THIS AREA WAS INCISED WITH BIPOLAR CAUTERY. DURING TH

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 TOTAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, AND PARA-AORTIC LYMPHADENECTOMY FOR OVARIAN CANCER ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. PER THE SURGICAL NOTE, THE ABDOMEN WAS FIRST ENTERED BY SCOPE AT THE LEVEL OF THE LEFT UPPER QUADRANT RIGHT BELOW THE RIB CAGE IN ORDER TO OBSERVE IF THERE WERE ADHESIONS FROM THE PREVIOUS CHOLECYSTECTOMY IN THE UPPER ABDOMEN CLOSE TO THE UMBILICUS, BECAUSE SHE PRESENTED A LARGE SCAR. ADHESIONS WERE SEEN AND LYSED BY ENDO SHEARS AND MONOPOLAR CURRENT OVER A 10-15 MINUTE TIME BEFORE THE CAMERA COULD BE INSERTED. SURGICAL FINDINGS ALSO NOTED ENLARGED LYMPH NODES SUSPICIOUS FOR MALIGNANCY AND AN ENLARGED FIBROID UTERUS THAT REQUIRED MORCELLATION FOR REMOVAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. SHE WAS INSTRUCTED TO FOLLOW UP WITH THE SURGEON IN 7-10 DAYS. AROUND (B)(6) 2013,

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2013. DURING THE SURGICAL PROCEDURE, THE PLAINTIFF'S ATTORNEY CLAIMS THAT THE PATIENT SUSTAINED A PROBABLE BURN INJURY TO HIS BOWEL WHICH LATER CAUSED HIS DEATH. ISI WAS NOT PROVIDED WITH THE DA VINCI-ASSISTED OPERATIVE REPORT OR ANY MEDICAL RECORDS. 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 AT AN UNSPECIFIED TIME, EITHER DURING OR AFTER A DA VINCI GASTRIC BYPASS PROCEDURE, THE PATIENT EXPIRED. THE SURGEON INDICATED THAT THIS CASE WAS REVIEWED BY A COMMITTEE OF PEERS, ADMINISTRATORS, THE MEDICAL AND LEGAL DEPARTMENT AND IT WAS CONFIRMED THAT THE PATIENT'S DEATH WAS NOT RELATED TO A ROBOTIC COMPLICATION NOR WAS IT SURGICAL MISADVENTURE. 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: 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 AND COMPLETE PELVIC LYMPHADENECTOMY PROCEDURE ON (B)(6) 2013 FOR STAGE 1B1 SQUAMOUS CELL CARCINOMA OF THE CERVIX. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE DA VINCI SURGICAL SYSTEM INJURED THE PATIENT AND SPREAD UNDIAGNOSED UTERINE CANCER THROUGHOUT THE PATIENT'S BODY. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS FROM THE SURGICAL PROCEDURE WAS 100 CC. THE SURGICAL PROCEDURE WAS COMPLETED AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. ON (B)(6) 2013, AND (B)(6) 2014, THE PATIENT UNDERWENT A CT-SCAN OF HER ABDOMEN AND PELVIS. THE IMPRESSION FROM (B)(6) 2013 CT-SCAN SHOWED NO DEFINITIVE EVIDENCE OF METASTATIC DISEASE. THE IMPRESSION FROM THE (B)(6) 2014 INCLUDED NEW CARCINOMATOSIS AND OMENTAL CAKING CONSISTENT WITH NEW METASTATIC

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 SURGICAL PROCEDURE, THE FIRST ASSISTANT INTRODUCED AN ENDOSCOPIC STAPLER INSTRUMENT THROUGH AN ASSISTANT PORT. REPORTEDLY, THE INSTRUMENT DID NOT GO ALL THE WAY ACROSS THE DORSAL VEIN COMPLEX, CAUSING THE PATIENT TO BLEED PROFUSELY. THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES; HOWEVER, THE PATIENT EXPIRED. 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI NISSEN FUNDOPLICATION AND CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED AN ESOPHAGEAL PERFORATION ON POST-OP DAY 1. ON (B)(6) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING THE FIRST HALF OF THE SURGICAL PROCEDURE. DURING THE TIME THE CSR WAS PRESENT DURING THE CASE, SHE DID NOT WITNESS ANY INTRA-OPERATIVE COMPLICATIONS OR ISSUES WITH THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2013, THE CSR STATED THAT SHE SPOKE TO THE SURGEON AND WAS TOLD THAT THE PATIENT HAD PASSED AWAY. THE DATE AND CAUSE OF THE PATIENT'S DEMISE WAS NOT PROVIDED BY THE SURGEON. THE CSR INDICATED THAT THE SURGEON INFORMED HER THAT SHE FELT AS THOUGH THE DA VINCI SURGICAL PROCEDURES WENT WELL. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS OR A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CSR.

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 LOWER ANTERIOR RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INDICATED THAT THE PATIENT EXPERIENCED A STROKE AND SUBSEQUENTLY PASSED AWAY ON AN UNSPECIFIED DATE. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT HAD MANY CO-MORBID CONDITIONS, WOKE UP BLIND, AND LATER PASSED AWAY. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGER (RM) AT THE SITE. THE RM REVIEWED THE PATIENT'S MEDICAL HISTORY AND NOTED THAT THE PATIENT HAD EXPERIENCED MULTIPLE STROKES IN THE PAST PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT'S MEDICAL HISTORY INCLUDED PROSTATE CANCER, ABDOMINAL ANEURYSMS, AORTIC ANEURYSM, CORONARY ATHEROSCLEROSIS, HEART DISEASE, COLON CANCER, HYPERTENSION, DIASTOLIC DYSFUNCTION, AND CHRONIC TOBACCO USE. THE RM ALSO REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY NOTATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ACCORDING TO THE OPERATIVE REPORT, THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT WOKE UP POST-OPERATIVELY WITH CO

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 HOURS AFTER A DA VINCI PARAESOPHAGEAL HERNIA PROCEDURE THE PATIENT HAD EXPIRED. IT WAS NOTED THAT THE PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES FOR AN UNKNOWN REASON AND THAT THE PATIENT HAD CHRONIC PRE-EXISTING MEDICAL CONDITIONS THAT CONTRIBUTED TO THEIR DEATH. 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: ON (B)(6) 2013, A PATIENT UNDERWENT A DA VINCI MITRAL VALVE REPAIR PROCEDURE. THE SITE EXPERIENCED SEVERAL FAULTS WITH THE PATIENT SIDE MANIPULATOR ARM (PSM) 2 WITH THE DA VINCI SYSTEM AND CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE FAULTS WERE RECOVERED AND THE SITE COMPLETED THE DA VINCI PROCEDURE. THE SITE WAS INFORMED THAT AN ISI FIELD SERVICE ENGINEER (FSE) WOULD COME OUT TO INSPECT THE DA VINCI SYSTEM. AT AN UNSPECIFIED TIME AFTER THE DA VINCI SYSTEM WAS UNDOCKED FROM THE PATIENT, THE PATIENT SUBSEQUENTLY EXPIRED. ISI DID NOT BECOME AWARE OF THE PATIENT'S DEATH UNTIL THE FOLLOWING DAY WHEN AN ISI FSE VISITED THE SITE TO INSPECT THE DA VINCI SYSTEM. A NURSE AT THE SITE HAD INFORMED THE FSE THAT THE PATIENT DIED AFTER THE DA VINCI SURGICAL PROCEDURE. THE DA VINCI SYSTEM WAS REPAIRED AND VERIFIED TO BE READY FOR USE. ON (B)(6) 2013, THE SURGEON INFORMED AN ISI REPRESENTATIVE THAT THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE DA VINCI SYSTEM BUT THE SURGEON DID NOT PROVIDE ANY FURTHER DETAILS. ON (B)(6) 2013, ISI CLINICAL CONSULTANT SPOKE WITH THE SURGEON INVOLVED WITH THE REPORTED EVENT. THE SURGEON VERIFIED THAT THE PATIENT DIED FOLLOWING A DA VINCI MITRAL

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 COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT SUDDENLY DIED TWO DAYS LATER ON (B)(6) 2013 JUST BEFORE DISCHARGE FROM THE HOSPITAL. ACCORDING TO THE SITE'S ROBOTICS COORDINATOR, THE CAUSE OF THE PATIENT'S DEATH WAS IDENTIFIED AS A PULMONARY EMBOLISM. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGER (RM) FROM THE SITE. THE RM INDICATED THAT THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RM WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ON (B)(6) 2013, ISI ALSO CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS INFORMED OF THE REPORTED EVENT BY THE ROBOTICS COORDINATOR. ACCORDING TO THE CSR, THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE INITIAL REPORTER OF THIS COMPLAINT, THE ROBOTICS COORDINATOR, TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE ROBOTICS COORDINATOR AS OF THE DATE OF THIS 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON 2009 OR 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DURING SURGERY A HOLE WAS CUT IN STOMACH. PATIENT BECAME SEPTIC AND F/U SURGERY DONE. CLIENT IS DECEASED.

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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR POORLY DIFFERENTIATED ENDOMETRIAL CANCER ON (B)(6) 2013. THE PATIENT ALSO UNDERWENT LYMPH NODE MAPPING, BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY, OMENTAL BIOPSY, AND CYSTOSCOPY. 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. ACCORDING TO THE OPERATIVE REPORT, NO COMPLICATIONS WERE REPORTED. POST-OPERATIVELY, THE PATIENT'S MENTAL STATUS CONSISTED OF CONFUSION. HOWEVER, AT THE TIME OF DISCHARGE ON (B)(6) 2013, THE PATIENT WAS REPORTEDLY FINE. THE PATIENT HAD POSITIVE BOWEL SOUNDS. ON (B)(6) 2013, THE PATIENT HAD COMPLAINTS OF SEVERE LOWER ABDOMINAL PAIN AND COULD NOT GET OUT OF BED. PAIN MEDICATIONS WERE NOT HELPING. THE PATIENT WAS ADVISED TO CALL FOR AN AMBULANCE AND REPORT TO A PHYSICIAN AS SOON AS POSSIBLE. ON (B)(6) 2013, THE PATIENT WAS SEEN IN AN ER. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS SINCE PRIOR TO SURGERY. SHE HAD N

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 HYSTERECTOMY PROCEDURE, THE PATIENT CODED DURING VAGINAL CUFF CLOSURE. AT THE TIME THE PATIENT CODED, THE INITIAL REPORTER INDICATED THAT THE DA VINCI S SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF WAS UNABLE TO REVIVE THE PATIENT WHO SUBSEQUENTLY PASSED AWAY.

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 SI ATRIAL APPENDAGE LIGATION PROCEDURE, THE SURGEON INADVERTENTLY CUT THE ATRIAL ARTERY DUE TO IMPROPER ANATOMY IDENTIFICATION AND THE PATIENT SUBSEQUENTLY PASSED AWAY. THE OR DIRECTOR FROM THE SITE INDICATED THAT ADHESIONS AND HEART ANATOMY ALTERED DUE TO PREVIOUS SURGERY LEAD TO IMPROPER IDENTIFICATION OF ANATOMY. THE OR DIRECTOR STATED THE DA VINCI SYSTEM DID NOT CONTRIBUTE TO THE PATIENT OUTCOME. THE CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT THE PATIENT HAD PREVIOUS HEART SURGERY AND THE LEFT ATRIAL ARTERY WAS REROUTED IN AN IMPROPER POSITION THAT THE SURGEON WAS NOT AWARE OF. THE CSR ALSO INDICATED THAT THE PATIENT HAD ADHESIONS THAT CONTRIBUTED TO IMPROPER ANATOMY IDENTIFICATION. AFTER THE ATRIAL ARTERY WAS INADVERTENTLY CUT, THE SURGEON MADE THE DECISION TO OPEN THE PATIENT UP AND ATTEMPT TO STOP THE BLEEDING. THE CSR INDICATED THAT THE PATIENT DID NOT SURVIVE THE SURGERY. ACCORDING TO THE CSR, THE SURGEON INDICATED THAT THE DA VINCI SYSTEM DID NOT MALFUNCTION DURING THE SURGICAL PROCEDURE AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE.

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 SI LOBECTOMY PROCEDURE, THE SURGEON TORE THE PATIENT'S PULMONARY VEIN. THE INITIAL REPORTER INDICATED THAT WHILE THE SURGEON WAS USING A CADIERE FORCEPS INSTRUMENT AND A MARYLAND BIPOLAR FORCEPS INSTRUMENT, THE PATIENT'S PULMONARY VEIN WAS TORN. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT RECEIVED 20 UNITS OF BLOOD AND LEFT SURGERY IN STABLE CONDITION.

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 COMPLETION OF A DA VINCI SI SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT PASSED AWAY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT PASSED AWAY AFTER A SUCCESSFUL GASTRIC SLEEVE PROCEDURE. IN ADDITION, THE SURGEON STATED THAT THE PATIENT'S AUTOPSY DID NOT FIND ANY SURGICAL 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL LOOP DIVERSION AND RADICAL PROSTATECTOMY WITH BILATERAL EXTENDED PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2013. AT THE TIME, THE PATIENT WAS SUFFERING FROM PAPILLARY UROTHELIAL CARCINOMA, HIGH GRADE, OF THE BLADDER. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES THAT CAUSED HIM TO UNDERGO ADDITIONAL SURGERIES. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, AROUND POST-OPERATIVE DAY 4, THE PATIENT BEGAN EXPERIENCING COMPLICATIONS HIGHLY INDICATIVE OF POSSIBLE BOWEL PERFORATION AND LEAK, WHICH SIGNS AND SYMPTOMS WERE NOT PROPERLY RECOGNIZED AND ADDRESSED UNTIL POST-OPERATIVE DAY FOURTEEN (14). AS A RESULT, THE PATIENT ALLEGEDLY DEVELOPED AN INTRA-ABDOMINAL ABSCESS AND SEPTIC SHOCK, AND ULTIMATELY PASSED AWAY ON (B)(6) 2013.

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 COMPLETION OF A DA VINCI SI SUPRAGLOTTIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 2 DAYS LATER ON (B)(6) 2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO COMPLICATIONS DURING THE DA VINCI SI SURGICAL PROCEDURE AND THE PATIENT HAD BEEN TAKEN TO THE ICU FOR RECOVERY.

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 COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A BOWEL PERFORATION AND REPORTED COMPLAINTS OF SEVERE PAIN ON POST-OP DAY 1. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT WAS FOUND TO BE SEPTIC. ON POST-OP DAY 3, AN OPERATION WAS PERFORMED TO REMOVE NECROTIC BOWEL. THE PATIENT SUBSEQUENTLY 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 AFTER COMPLETION OF A DA VINCI SI SIGMOID COLECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 7 DAYS LATER ON (B)(6)2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON PERFORMED AN ANASTOMOSIS DURING THE SURGICAL PROCEDURE AND A LEAK WAS FOUND AFTER A LEAK TEST WAS DONE. AFTER THE SURGEON REPAIRED THE LEAK BY APPLYING SUTURES, ANOTHER LEAK TEST WAS PERFORMED AND NO FURTHER COMPLICATIONS WERE FOUND. THE SURGICAL PROCEDURE WAS COMPLETED. THE DAY AFTER SURGERY, THE PATIENT WAS REPORTEDLY DOING FINE. HOWEVER, OVER THE FOLLOWING WEEKEND, THE PATIENT WAS NOT DOING WELL. ACCORDING TO THE INITIAL REPORTER, A CT SCAN WAS PERFORMED ON THE PATIENT ON (B)(6) 2013, AND NO ISSUES WERE SEEN. THE INITIAL REPORTER INDICATED, HOWEVER, THAT AN ANASTOMOSIS DYE TEST WITH X-RAY WAS PERFORMED AND A LEAK WAS SEEN. THE PATIENT WAS RUSHED TO SURGERY AND THE PATIENT EXPIRED IN THE OPERATING ROOM (OR).

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 09/06/2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LETTER FROM AN ATTORNEY SEEKING INFORMATION RELATED TO A DA VINCI SYSTEM. IT WAS REPORTED IN THE LETTER THAT A PATIENT HAD DIED FOLLOWING VASCULAR DAMAGE THAT WAS INCURRED AT THE TIME OF INITIATING A DA VINCI ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2013. ON (B)(4) 2013, ISI SPOKE WITH THE ATTORNEY REPRESENTING THE HOSPITAL. SHE CONFIRMED THAT THE DA VINCI SYSTEM WAS NEVER USED DURING THE PROCEDURE. SHE COULD NOT PROVIDE THE CAUSE OF DEATH AS THE RESULTS OF THE AUTOPSY ARE STILL PENDING. THE PATIENT'S INJURY WAS NOTICED UPON INSERTION OF THE CAMERA SCOPE INTO THE FIRST NON-ISI TROCAR THAT WAS INSERTED. THE PATIENT'S HYSTERECTOMY PROCEDURE WAS PLANNED TO BE A ROBOTIC ASSISTED LAPAROSCOPIC HYSTERECTOMY; HOWEVER, THE PATIENT'S HYSTERECTOMY WAS NOT PERFORMED AS THE BLEED WAS NOTICED BEFORE THE SURGERY. THE DA VINCI SYSTEM WAS NOT USED. THE ATTORNEY ALSO STATED THAT THE SURGEON DOES NOT FEEL THAT THE PATIENT'S DEATH DID INVOLVE ANY TYPE OF MALFUNCTION OF ANY DEVICE.

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 30 HOURS POST-OP A DA VINCI SI ROUX-EN-Y PROCEDURE ON (B)(6) 2013, DURING AN EXPLORATORY PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT HAD AN ANASTOMOTIC LEAK. THE LEAK CAUSED THE PATIENT'S ORGANS TO BECOME ACIDIC AND RESULTED IN THE PATIENT'S DEMISE ON (B)(6) 2013. ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. ACCORDING TO THE SURGEON, THE PATIENT BEGAN TO PRESENT COMPLICATIONS 1 DAY POST-OP. THE PATIENT UNDERWENT AN EXPLORATORY SURGICAL PROCEDURE AND IT WAS DISCOVERED THAT THE PATIENT HAD AN ANASTOMOTIC LEAK. THE AFFECTED AREA WAS REPAIRED. THE SURGEON INDICATED THAT NO MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE (B)(6) 2013 SURGICAL PROCEDURE AND THAT INTRA-OPERATIVELY THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS. THE SURGEON STATED THAT THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE ANASTOMOTIC LEAK AND SUBSEQUENT DEMISE OF THE PATIENT WERE UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS AND ACCESSORIES. HE STATED THAT THE COMPLICATIONS EXPERIENCED BY THE PATIENT WERE THE RESULT OF THE ANASTOMOTIC LEAK. ON (B)(4) 2013, ISI

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 ADDITIONAL INFORMATION REGARDING THE PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SACROCOLPOPEXY, CYSTOSCOPY, FULGURATION OF BLADDER LESION, AND REPAIR OF A BLADDER LACERATION FOR CYSTOCELE AND BLADDER LESION ON (B)(6) 2013. THE PATIENT HAD A HISTORY OF BLADDER CANCER. 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. PRIOR TO THE UNDERGOING THE DA VINCI SURGICAL PROCEDURE, INFORMED CONSENT WAS OBTAINED. THE PATIENT HAD A HISTORY OF BLADDER CANCER, PRIOR ABDOMINAL SURGERIES, A HYSTERECTOMY, AND A CHOLECYSTECTOMY. AS A RESULT OF PRIOR SURGERIES, THE PATIENT HAD ADHESIONS. DURING THE SURGERY, AN OPENING IN THE BLADDER WAS NOTED AND REPAIRED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. THE ESTIMATED BLOOD LOSS WAS 100 ML. POST-OPERATIVELY, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. AN UNSPECIFIED TIME LATER, THE PATIENT BECAME HYPOTENSIVE, APP