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

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 UNDERWENT A DA VINCI ASSISTED LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS PROCEDURE ON (B)(6) 2013 FOR MORBID OBESITY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND PATIENT'S MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED. IN ADDITION, THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. ON POST-OPERATIVE DAY (POD) 1, THE PATIENT'S UPPER GI WAS FOUND TO BE NORMAL. THE PATIENT WAS STARTED ON CLEAR LIQUIDS AND ADVANCED TO FULL LIQUIDS AND PROTEIN DRINK, WHICH SHE TOLERATED WELL. ON (B)(6) 2013, THE PATIENT WAS TOLERATING LIQUIDS AND HER CREATININE LEVEL WAS BACK TO BASELINE AT 2.79. THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, SHE WAS RE-ADMITTED FOR HYDRATION AND DIABETES MANAGEMENT UNTIL BEING DISCHARGED ON (B)(6) 2013. BY (B)(6) 2013, THE PATIENT BEGAN TO DEVELOP INCREASING SHORTNESS OF BREATH, PAIN, CONFUSION AND DISORIENTATION WITH SIGNIFICANT ABDOMINAL DISCOMFORT AND PAIN WITH LOW BLOOD PRESSU

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 WHO UNDERWENT A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2013, EXPIRED POST-OPERATIVELY. A SURGEON WHO WAS PART OF THE CARDIAC TEAM AT THE SITE INFORMED AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT THE SURGICAL PROCEDURE WAS ABANDONED SINCE THE PATIENT DEVELOPED PULMONARY EDEMA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PROCEDURE OR ABOUT 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: IT WAS REPORTED THAT DURING A DA VINCI SI THORACIC PROCEDURE, THE PATIENT EXPIRED. REPORTEDLY, PRIOR TO THE PATIENT'S DEMISE, WHILE THE SURGEON WAS MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CONSOLE, THE SURGEON WAS UNABLE TO CONTROL OR MOVE THE INSTRUMENT INSTALLED ON A PATIENT SIDE MANIPULATOR (PSM) ARM 1. REPORTEDLY, THE SITE OBSERVED THAT THE LED ON PSM 1 WAS SOLID BLUE IN COLOR WHEN THE ISSUE OCCURRED AND THEY WERE EVENTUALLY ABLE TO RESOLVE THE ISSUE. ON (B)(6) 2013, INTUITIVE SURGICAL CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO HIS INABILITY TO MANIPULATE THE INSTRUMENT INSTALLED ON PSM 1, BUT RATHER THE PATIENT'S CONDITION. THE PATIENT WAS VERY SICK AND WAS NOT DOING VERY WELL UNDER ANESTHESIA. THE SURGEON INDICATED THAT HE HAD INTENDED TO PERFORM LUNG DECORT USING THE DA VINCI SURGICAL SYSTEM; HOWEVER, AFTER THE SYSTEM WAS DOCKED TO THE PATIENT AND WHEN HE SAT DOWN AT THE SSC, HE WAS UNABLE TO MOVE THE INSTRUMENT THAT WAS INSTALLED ON THE PSM. THE PATIENT HAD CHEST ADHESIONS AND AS A RESULT HE HAD TO CREATE LARGER PORT SITE INCISIONS. HE DID NOT OBSERVE ANY RESTRICTIO

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 NISSEN FUNDOPLICATION PROCEDURE, AFTER THE SURGEON COMPLETED SUTURING, THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS RELATED TO A PULMONARY EMBOLISM AND THAT THE PATIENT'S DEMISE WAS UNRELATED TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. IT IS BELIEVED THAT THE PATIENT EXPERIENCED COMPLICATIONS TO BLEEDING. 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 POST-OP A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT CODED. THE SITE ATTEMPTED TO RESUSCITATE THE PATIENT; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2013, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE WHO WAS MADE AWARE OF THIS INCIDENT, INDICATED THAT SHE WAS AT A GATHERING WHEN THIS INFORMATION WAS TOLD TO HER BY A SCRUB TECHNICIAN WHO WAS ASKED TO ASSIST WITH RESUSCITATION OF THE PATIENT. REPORTEDLY, THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT WHEN THE PATIENT BEGAN TO CODE. THE PATIENT HAD A PULMONARY EMBOLISM. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2013, ISI CONTACTED THE SITE TO GATHER ADDITIONAL INFORMATION. THE SITE'S RISK MANAGER INDICATED THAT THEY HAD NO RECORD OF A PATIENT DEATH RELATED TO A DA VINCI SURGICAL PROCEDURE AS THEY DO NOT HAVE A DA VINCI SURGICAL SYSTEM AND THAT THE INITIAL REPORTER OF THE INCIDENT WAS NO LONGER AN EMPLOYEE OF THE HOSPITAL.

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 NISSEN FUNDOPLICATION PROCEDURE, ONE OF THE PATIENT'S VESSELS WAS COMPROMISED WHILE THE SURGEON WAS PERFORMING HIS LAST STITCH. THE BLEEDING WAS SECURED AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. THE PATIENT SUBSEQUENTLY EXPIRED IN THE OPERATING ROOM DUE TO BLOOD LOSS AND PRE-EXISTING CONDITIONS.

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 MYOMECTOMY PROCEDURE, WHILE UNDOCKING THE SYSTEM FROM THE PATIENT, THE PATIENT REQUIRED RESUSCITATION. THE ANESTHESIOLOGIST PERFORMED CHEST COMPRESSIONS ON THE PATIENT; HOWEVER, THE RESUSCITATION ATTEMPTS FAILED AND THE PATIENT EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6) FEMALE UNDERGOING A ROBOTIC MYOMECTOMY AND BILATERAL NEOSALPINGOSTOMY HAD AN INTRAOPERATIVE DEATH. NEAR THE END OF THE PROCEDURE, THE PT'S BLOOD PRESSURE WAS NOT DETECTED IN THE PRESENCE OF A PULSE AND NORMAL OXYGENATION LEVELS. THE RHYTHM WAS NOTED TO BE PULSELESS ELECTRICAL ACTIVITY (PEA). DESPITE ACLS PROCEDURES AND AN ATTEMPT TO INSERT AN INTRA-AORTIC BALLOON PUMP TO SUSTAIN THE PT, ALL RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. RESUSCITATIVE EFFORTS WERE SUSTAINED FOR OVER 2 HRS AT NO TIME WAS A PROBLEM WITH THE ROBOTIC EQUIPMENT REPORTED. THIS WAS AN UNEXPECTED DEATH. PROVISIONAL AUTOPSY RESULTS: AV SEPTUM REVEALED AN AREA OF BLEEDING AND FATTY INFILTRATION. THERE WAS FATTY INFILTRATION OF THE LIVER. HOWEVER, IN THE ABSENCE OF OTHER FINDINGS, DEFINITIVE CHARACTERIZATIONS FOR THE CAUSE OF THE ARRHYTHMIA AND LEFT VENTRICULAR FAILURE IS NOT POSSIBLE. THE FINAL RESULTS ARE STILL 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE WITH BILATERAL URETEROLYSIS AND LYSIS OF SEVERE ADHESIONS FOR HIGH RISK UTERINE CANCER (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT SUSTAINED A SMALL BOWEL PERFORATION, DEVELOPED NECROTIZING FASCIITIS, AND SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. POST-OPERATIVELY, THE PATIENT'S ABDOMEN WAS FOUND TO BE SOFT AND BOWEL SOUNDS WERE PRESENT. NO DISTENTION WAS OBSERVED. THE PATIENT WAS ABLE TO AMBULATE, TOLERATE A REGULAR DIET, AND VOID. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED. ON (B)(6) 2013, THE PATIENT WAS ADMITTED WITH WORSENING ABDOMINAL PAIN, SOMNOLENCE, AND ANOREXIA. THE PATIENT WAS FOUND TO BE TACHYCARDIC, HYPOTENSIVE, AND HYPOXIC. THE PATIENT'S WHITE BLOOD CELL COUNT WAS 5.9 WITH 92% BANDS. A CT SCAN SHOWED FREE INTRAPERITONEAL AIR AND FREE AIR ALONG THE ENTIRE LEFT SIDE OF THE ABDOMEN. THE PATIENT WAS TAKEN URGENTLY TO THE OPERATING ROOM AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED. ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL WERE O

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 FEW DAYS POST OP A DA VINCI SI ENDOMETRIOSIS RESECTION PROCEDURE, PERFORMED ON (B)(6) 2013, THE PATIENT EXPIRED AT HOME. DURING THE SURGICAL PROCEDURE, EXTENSIVE RESECTION WAS COMPLETED ON THE PATIENT'S LEFT PELVIS SURROUNDING THE URETER AND COLON.

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 SEVERAL DAYS POST A DA VINCI SINGLE SITE CHOLECYSTECTOMY PROCEDURE THE PATIENT EXPIRED AT HOME.

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 OP A DAVINCI SI GYNECOLOGICAL PROCEDURE, THE PATIENT EXPIRED DUE TO SEPSIS AS RESULT OF A SUSPECTED BOWEL INJURY.

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 NEPHRECTOMY PROCEDURE FOR A LEFT RENAL MASS ON (B)(6) 2013. 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. NO OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 50 ML. POST-OPERATIVELY, THE PATIENT WAS DOING FINE UNTIL THE MORNING OF (B)(6) 2013 WHEN HER HEMOGLOBIN WAS FOUND TO HAVE DROPPED FROM 7.8 TO 5.5, AND SHE SUBSEQUENTLY BECAME HYPOTENSIVE. HER ANTICOAGULATION, WHICH SHE HAD BEEN ON FOR HER ATRIAL FIBRILLATION, WAS STOPPED. A CT SCAN WAS PERFORMED AND SHOWED AN ANTERIOR WALL HEMATOMA AS WELL AS A HEMATOMA IN THE SURGICAL BED. SELECTIVE EMBOLIZATION WAS UNDERTAKEN OF THE INTERNAL MAMMARY ARTERY, AND THE PATIENT WAS TRANSFERRED BACK TO THE FLOOR AND RECEIVED FOUR UNITS OF PACKED CELLS. SHE INITIALLY RESPONDED, BUT AFTER MIDNIGHT ON (B)(6) 2013 SHE BECAME ACUTELY MORE HYPOTENSIVE AND HER URINE OUTPUT DECREASED. SHE WAS TRANSFERRED TO THE SURGICAL ICU FOR FURTHER EVALUATIO

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 MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI SI BARIATRIC BAND SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT WAS ADVISED AFTER THE DA VINCI SURGERY THAT THERE WAS A LEAK THAT NEEDED TO BE FIXED. APPROXIMATELY ON (B)(6) 2013, ANOTHER SURGERY WAS PERFORMED TO DRAIN THE PATIENT'S BODY CAVITY (10 LITERS WERE REMOVED). ON AN UNSPECIFIED DATE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED.