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) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED NOTIFICATION OF A BOSTONHERALD.COM ARTICLE TITLED, ROBOTS IN THE O.R.: SUIT TARGETS ROBOTIC SURGERY RISKS AND DATED NOVEMBER 20, 2014. ACCORDING TO THE ARTICLE, A PATIENT AGREED TO UNDERGO A DA VINCI HYSTERECTOMY ON AN UNSPECIFIED DATE IN THE SPRING OF 2009. THE ARTICLE INDICATES, THE SURGERY RESULTED IN A TEAR IN HER SMALL INTESTINE..., AND THE PATIENT, HAD SEPSIS, AND HAD SUBSEQUENT SURGERIES TO REPAIR THE TISSUE. SHE SPENT MONTHS IN AND OUT OF THE HOSPITAL. THE ARTICLE ALSO STATES, BECAUSE OF THE COMPLICATIONS, SHE COULDN'T COMPLETE CHEMOTHERAPY AND NEVER STARTED RADIATION TREATMENT. SHE DIED ON (B)(6) 2010. THERE IS NO CLAIM WITHIN THE ARTICLE THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER SUCCESSFUL COMPLETION OF A DA VINCI COLON RESECTION PROCEDURE THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. UPON FOLLOW UP WITH THE SITE, THE RISK MANAGER AT THE HOSPITAL STATED THAT THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS, HOWEVER, RETURNED TO THE HOSPITAL ON (B)(6) 2014 WITH A FEVER AND REPORTED FATIGUE. NO ISSUES WERE IDENTIFIED AND NO TREATMENT WAS PROVIDED AND THE PATIENT WAS RELEASED HOME. THE PATIENT WAS FOUND EXPIRED IN HER HOME ON (B)(6) 2014. PER THE RISK MANAGER, NOTHING REGARDING THE PATIENTS OUTCOME LED HER TO BELIEVE THAT THE DA VINCI SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S OUTCOME. AS OF THE DATE OF THIS REPORT THE AUTOPSY RESULTS ARE PENDING.

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 TOTAL PROCTOCOLECTOMY WITH J-POUCH PROCEDURE ON (B)(6) 2014, THE PATIENT BLED OUT, HAD ORGAN FAILURE DUE TO BLOOD LOSS, AND PASSED AWAY ON (B)(6) 2014. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE INITIAL REPORTER INDICATED THAT THE SURGICAL PROCEDURE WAS PLANNED TO BE A COMBINATION OF A DA VINCI TOTAL PROCTOCOLECTOMY WITH J-POUCH AND TRADITIONAL LAPAROSCOPIC SURGERY. AFTER THE DA VINCI PORTION OF THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED, THE SURGEON FINISHED THE REMAINDER OF THE SURGERY VIA TRADITIONAL LAPAROSCOPIC SURGERY. NO INTRA-OPERATIVE COMPLICATIONS OR SIGNIFICANT BLEEDING WERE REPORTED DURING THE SURGERY. IN ADDITION, NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM WAS REPORTED. POST-OPERATIVELY, THE PATIENT EXPERIENCED BLEEDING AND SUBSEQUENTLY PASSED AWAY ON POST-OP DAY 10. THE INITIAL REPORTER INDICATED THAT HE SPOKE TO VARIOUS SURGEONS AT THE SITE REGARDING 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SURGICAL PROCEDURE ON (B)(6) 2014. THE PLAINTIFF'S ATTORNEY ALLEGES THAT AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT SUSTAINED SERIOUS AND PERMANENT BODILY INJURY AND ULTIMATELY PASSED AWAY ON (B)(6) 2014. ISI WAS NOT PROVIDED WITH THE DA VINCI OPERATIVE REPORT OR ANY OF 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 SINGLE-SITE CHOLECYSTECTOMY PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 1. DURING THE SURGICAL PROCEDURE, THE INITIAL REPORTER OF THIS COMPLAINT INDICATED THAT THE SURGEON WAS HAVING ISSUES WITH CLIPS DISLODGING FROM A SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT DURING INSERTION THROUGH A CANNULA. TOWARDS THE END OF THE SURGICAL PROCEDURE, A CLIP INSTALLED ON THE SINGLE-SITE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FELL INSIDE THE PATIENT. THE SURGEON SPENT ABOUT 10 MINUTES SEARCHING FOR THE CLIP USING A SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT AND A SINGLE-SITE CROCODILE GRASPER INSTRUMENT. DURING THE PROCESS OF SEARCHING FOR THE CLIP, THE SURGEON LACERATED THE LOWER LOBE OF THE PATIENT'S LIVER AS HE WAS MANIPULATING OR LIFTING THE ORGAN WITH THE SINGLE-SITE MONOPOLAR CAUTERY INSTRUMENT. THE SURGEON WAS ABLE TO CONTROL BLEEDING THAT ENSUED BY CAUTERIZING THE LACERATION. THE SURGEON THEN PROCEEDED TO COMPLETE THE DA VINCI SURGICAL PROCEDURE. PRIOR TO COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT ALSO UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE AND UNSPECIFIED HERNIA REPAIR PROCEDURE. ACCORDING TO 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 AFTER UNDERGOING A DA VINCI RIGHT TRANSVERSE COLECTOMY PROCEDURE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT (ED) 2 WEEKS POST-OPERATIVELY WITH SYMPTOMS OF A FEVER. THE PATIENT SUBSEQUENTLY PASSED AWAY WITH UNKNOWN ETIOLOGY. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO SIGNS OF AN ADVERSE EVENT AT THE TIME OF SURGERY AND SHORTLY THEREAFTER. ON (B)(6) 2014, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) WHO WAS PRESENT DURING PART OF THE DA VINCI SURGICAL PROCEDURE. ACCORDING TO THE CSR, HE WAS PRESENT DURING SETUP OF THE PROCEDURE AND UP UNTIL ABOUT HALF WAY THROUGH COMPLETION OF THE SURGERY. THE CSR INDICATED THAT DURING THE PROCEDURE, THE SURGICAL STAFF ENCOUNTERED AN ISSUE AT ONE POINT WHERE PATIENT SIDE MANIPULATOR (PSM) 1 DID NOT RECOGNIZE AN INSTRUMENT. THE PSM IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART (PSC) THAT PROVIDES STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENT. THE CSR STATED THAT THE SURGICAL STAFF SWAPPED INSTRUMENTS BETWEEN THE PSMS AND EVERYTHING WORKED PROPERLY FROM THAT POINT ON. DURING THE TIME THE CSR WAS PRESENT DURING THE PROCEDURE, THERE WERE NO INTRA-OPERATIV

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