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

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A CLINICAL RESEARCH SITE REPORTED THAT STUDY PT (B)(6) RECEIVED CYBERKNIFE TREATMENT FOR PROSTATE CANCER ON (B)(6) 2009. IN (B)(6) 2013, THE PT WAS DIAGNOSED WITH A GRADE 3 PAPILLARY BLADDER 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 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.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INTRAOPERATIVE DEATH SECONDARY TO CARDIOVASCULAR ARREST SECONDARY TO SURGICAL BLEEDING DURING RADICAL NEPHRECTOMY.

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 NEPHRECTOMY PROCEDURE, THE PATIENT'S RENAL ARTERY, AORTA AND VENA CAVA WERE PUNCTURED AND THE PATIENT SUBSEQUENTLY EXPIRED. REPORTEDLY, THERE WAS NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI PULMONARY WEDGE RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. AT THE TIME OF THE CONVERSION, THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT AND THE PATIENT WAS REPORTEDLY IN STABLE CONDITION AND WAS DOING FINE. AT AN UNSPECIFIED TIME DURING THE OPEN SURGICAL PROCEDURE, THE PATIENT SUBSEQUENTLY EXPIRED. NO ADDITIONAL 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 AFTER COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT EXPIRED DURING RECOVERY. NO OTHER DETAILS WERE PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES FOR AN UNKNOWN REASON AND 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ASSISTED ELECTIVE SIGMOID COLECTOMY PROCEDURE FOR RECURRENT ACUTE DIVERTICULITIS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND PATIENT'S MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT HAD 2 WELL DOCUMENTED EPISODES OF ACUTE DIVERTICULITIS. ONE EPISODE INVOLVED A SMALL PERICOLIC ABSCESS. DURING THE SURGICAL PROCEDURE, ADHESIONS WERE NOTED. NO COMPLICATIONS WERE REPORTED. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. POST-OPERATIVELY, THE PATIENT DEVELOPED URINARY RETENTION WHICH WAS RESOLVED BY DISCHARGE. THE PATIENT WAS ABLE TO TOLERATE A REGULAR DIABETIC DIET. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED ON ORAL PAIN MEDICATION. ON (B)(6) 2013, A CT-SCAN WAS PERFORMED FOR CONSTIPATION AND THE PATIENT WAS FOUND TO HAVE A SMALL BOWEL OBSTRUCTION AND A PRIOR COLON RESECTION WITH ANASTOMOTIC SITE NOTED AT THE RECTOSIGMOID JUNCTION. POST-SURGICAL CHANGES VERSUS RESIDUAL INFLAMMATORY CHANGES WERE ALSO OBSERVED IN THE LEFT LOWER QUADRANT. ALSO, SMALL FREE FLUID WAS OBSE

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 EXPIRED AFTER UNDERGOING A TONSILLECTOMY, PHARYNGECTOMY, PARTIAL GLOSSECTOMY USING THE DA VINCI SURGICAL SYSTEM FOR TONSILLAR CANCER ON (B)(6) 2013. REPORTEDLY, THE SURGERY WAS PART OF A RESEARCH STUDY CLEARED BY THE FDA. THE PATIENT'S MEDICAL RECORDS WERE PROVIDED TO ISI FOR REVIEW. ACCORDING TO THE INFORMATION IN THE PATIENT'S OPERATIVE REPORT, THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S SUBSEQUENT POST SURGICAL COMPLICATIONS AND DEATH. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS EXTUBATED WITHOUT INCIDENT IN THE OPERATING ROOM AND WAS TRANSFERRED IN STABLE CONDITION TO THE RECOVERY ROOM. NO COMPLICATIONS WERE EXPERIENCED BY THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. BASED ON THE INFORMATION PROVIDED IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013 THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM DUE TO SIGNIFICANT ORAL BLEEDING AND PEA ARREST WITH ROSC AFTER APPROXIMATELY 12 MINUTES OF C

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 THE PATIENT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. REPORTEDLY 36 HOURS AFTER SUCCESSFUL COMPLETION OF THE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE PATIENT'S BOWEL WAS PUNCTURED. IT WAS REPORTED THAT 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED SIGMOID COLECTOMY ON (B)(6) 2013 FOR ACUTE DIVERTICULITIS AND DIVERTICULAR ABSCESS. THE LEGAL CLAIM ALLEGES THAT THE PATIENT SUSTAINED A THERMAL INJURY TO THE BOWEL, DEVELOPED POST-OPERATIVE SYMPTOMS, AND SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE DA VINCI OPERATIVE REPORT AND ADDITIONAL PATIENT MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE PATIENT'S MEDICAL RECORDS, SHE PRESENTED TO AN ER ON (B)(6) 2013 WITH COMPLAINTS OF ABDOMINAL PAIN AND NO BOWEL MOVEMENTS OF 4-5 DAYS DURATION. THE PATIENT WAS NOTED TO HAVE A HISTORY OF DIVERTICULITIS AND HAD BEEN HOSPITALIZED RECENTLY FOR TREATMENT OF DIVERTICULITIS. SHE HAD COMPLETED A COURSE OF ORAL ANTIBIOTICS 10 DAYS PRIOR. THE PATIENT WAS ADMITTED IN THE ER WITH DIAGNOSIS OF DIVERTICULAR ABSCESS. AN ABDOMINAL CT-SCAN PERFORMED ON (B)(6) 2013 NOTED A MASS-LIKE THICKENING AT THE DISTAL RECTOSIGMOID AND FLUID COLLECTION IN THE RIGHT HEMIPELVIS NEAR THE RECTOSIGMOID. ANTIBIOTIC TREATMENT FOLLOWED

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 LEFT UPPER LOBECTOMY PROCEDURE FOR A LEFT UPPER LOBE 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. PER THE OPERATIVE REPORT, ADHESIONS BETWEEN THE UPPER CHEST WALL AND THE LATERAL CHEST WALL OF THE LUNG WERE TAKEN DOWN USING HOOK CAUTERY. DISSECTION IN THE FISSURE PROCEEDED UNTIL SOME OF THE PULMONARY ARTERY BRANCHES COULD BE IDENTIFIED AND SEALED USING THE VESSEL SEALER INSTRUMENT. THE SURGEON NOTED, WE THEN WENT AHEAD AND CONTINUED WITH DISSECTION IN THE FISSURE UTILIZING AN ELECTROCAUTERY TO HELP EXPOSE WITH PULMONARY ARTERY...AT THIS POINT BECAUSE OF THE SIGNIFICANT ADHESIONS IN THE FISSURE, I WENT AHEAD AND DISSECTED PROXIMALLY IDENTIFYING THE PULMONARY VEIN. DISSECTION CONTINUED AND THE LUNG RESECTION WAS SUBSEQUENTLY COMPLETED. THE SURGEON INDICATED...AND AT THIS TIME I NOTED SOME BLEEDING COMING FROM THE TRUNCAL BRANCHES OF THE PULMONARY ARTERY. WE GRASPED WITH 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 WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY AND EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2013 FOR POORLY DIFFERENTIATED CARCINOMA OF PROBABLE ENDOMETRIAL ORIGIN, POSTMENOPAUSAL BLEEDING, ENLARGED UTERUS AND EXTENSIVE INTRAPERITONEAL ADHESIONS. 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 PATIENT'S MEDICAL RECORDS, A CYSTOSCOPY PERFORMED AT THE CONCLUSION OF THE DA VINCI SURGICAL PROCEDURE SHOWED GOOD EFFLUX OF URINE BILATERALLY FROM THE URETERAL OSTIA, AND NO VISIBLE BLADDER DEFECTS. NO OPERATIVE COMPLICATIONS WERE NOTED, AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY. THE DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. ON (B)(6) 2013, THE PATIENT PRESENTED TO AN ER WITH COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, VOMITING, AND DIARRHEA. A CT-SCAN SHOWED MULTIPLE DILATED LOOPS OF FLUID FILLED BOWEL CONSISTENT

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A WALL STREET JOURNAL ARTICLE INDICATED THE FOLLOWING DETAILS RELATED TO PATIENT DEATH: 'A FOLLOW-UP STORY REFERRED TO A CASE IN WHICH A (B)(6) MAN DIED FOLLOWING ROBOTIC SURGERY LAST SUMMER AT A (B)(6) HOSPITAL. AN ATTORNEY FOR THE MAN'S FAMILY SAID THE UROLOGIST WHO OPERATED ON HIM HAD NEVER BEFORE PERFORMED THE PROCEDURE HE WAS ATTEMPTING WITH THE ROBOT, ACCORDING TO THE REPORT.'

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IN A PUBLISHED CITRON RESEARCH ARTICLE TITLED INTUITIVE SURGICAL: ANGEL WITH BROKEN WINGS, OR DEVIL IN DISGUISE? ON JANUARY 17, 2013, IT WAS STATED ON PAGE 22 IN AN EMBEDDED ARTICLE LINK (CHICAGO DAILY LAW BULLETIN - FAMILY GETS $7.5 MILLION IN DEATH AFTER SPLEEN REMOVAL) THAT A (B)(6) MAN DIED ONE MONTH AFTER A DA VINCI SURGERY TO REMOVE HIS SPLEEN IN 2007. ALLEGEDLY, THE DECEDENT UNDERWENT THE SURGERY BECAUSE HE SUFFERED FROM A DISORDER THAT PREVENTED HIS BLOOD FROM PROPERLY CLOTTING. THE DECEDENT ALLEGEDLY SUFFERED TWO HOLES IN HIS DUODENUM, AN ORGAN THAT IS 6 TO 10 INCHES FROM THE SPLEEN. FURTHERMORE, ACCORDING TO THE ARTICLE, HE BECAME SICK AND DEVELOPED SEPSIS THAT CAUSED SEVERAL ORGANS TO FAIL POST-SURGERY. IT WAS ALSO ALLEGED THAT HE SUFFERED BRAIN DAMAGE AND DIED IN (B)(6) 2007. A MEDICAL-MALPRACTICE LAWSUIT WAS FILED AGAINST FOUR DOCTORS OF THE (B)(6) -BASED HOSPITAL, WHO REPORTEDLY DENIED THE ALLEGATION THAT THE DUODENUM HOLES OCCURRED DURING THE SURGERY. INTUITIVE SURGICAL WAS NOT NAMED AS A DEFENDANT IN THIS LAWSUIT. THESE ALLEGATIONS WERE NOT PREVIOUSLY REPORTED TO INTUITIVE SURGICAL AND HAVE NOT BEEN SUBSTANTIATED. ANY FURTHER INFORMATION RECEIVED BY THE COMPANY WILL

CyberKnife — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A REVIEW OF A DRAFT CLINICAL PUBLICATION, AN ACCURAY EMPLOYEE NOTICED AN ADVERSE EVENT DESCRIBED. THE PUBLICATION DESCRIBES A STUDY OF 26 PTS TREATED FROM 2007-2011. THE PTS WERE CONSIDERED INOPERABLE PTS WITH LOCALIZED LUNG TUMORS. ON PT, WHO WAS PRESENTED WITH STEROID-REFRACTORY RADIATION PNEUMONITIS AT EIGHT MONTHS POST-TREATMENT, DIED OF ACUTE RESPIRATORY FAILURE FOUR MONTHS LATER. THE PT HAD UNDERGONE A LEFT PNEUMONECTOMY PRIOR TO RECEIVING RADIATION TREATMENT. THE COMPLICATION IS A KNOWN RISK OF TREATING A TUMOR WITHIN THE GIVEN TREATMENT PARAMETERS AND TUMOR LOCATION. THE PHYSICIAN INDICATED THAT THE PLANNED TREATMENT WAS DELIVERED AS INTENDED AND THAT THE AE WAS NOT DUE TO A MALFUNCTION OF THE DEVICE.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PT ENROLLED IN A NON ACCURACY SPONSORED STUDY, UNDER (B)(4) OVERSIGHT, EXPERIENCED COMPLICATIONS. THE PT EXPERIENCED PELVIC PAIN AND PROSTATE SLOUGHING AND UNDERWENT A CYSTOPROSTATECTOMY. THE PHYSICIAN INDICATED THERE WAS NO MALFUNCTION OF THE DEVICE. DUE TO THE NATURE OF THE FOLLOW UP INTERVENTION, AND THE LACK OF RELATED DETAILS, THIS IS BEING REPORTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS ALLEGED THAT THE PATIENT HAD A MULTI-PORT CHOLECYSTECTOMY ON (B)(6) 2013 THAT RESULTED IN AN INJURY TO THE BOWEL FROM THE TROCAR DURING INSERTION AT THE BEGINNING OF THE CASE. THE PATIENT COMPLAINED ABOUT PAIN TWO DAYS AFTER THE SURGERY AND RETURNED TO THE HOSPITAL. THE PATIENT WAS READMITTED, ALLEGEDLY SEPTIC AND AN EMERGENCY SURGERY WAS PERFORMED TO REPAIR THE BOWEL. THE PATIENT EXPIRED 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY FOR AN UNKNOWN REASON ON (B)(6) 2013. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT. NO SUPPLEMENTAL INFORMATION WAS PROVIDED. ALLEGATIONS OF PATIENT COMPLICATIONS WERE AS FOLLOWS: THE PATIENT WAS TO HAVE A PARTIAL NEPHRECTOMY, BUT BECAUSE OF COMPLICATIONS WITH THE DA VINCI HIS ENTIRE KIDNEY WAS REMOVED. HE DEVELOPED A HERNIA AND UNDERWENT ANOTHER DA VINCI ASSISTED SURGERY TO REPAIR THE HERNIA, HOWEVER THE ROBOT MALFUNCTIONED AND THE SURGERY WAS UNABLE TO BE COMPLETED. ON YET THE THIRD DAY, THE PATIENT, UNDERWENT ANOTHER DA VINCI SURGERY TO REPAIR THE HERNIA. HE SUFFERED COMPLICATIONS, BECAME SEPTIC AND EXPIRED 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: THIS INITIAL MDR IS ACTUALLY BEING SUBMITTED AS A FOLLOW-UP #1 MDR REPORT FOR MFR REPORT #2955842-2014-02551 (PATIENT IDENTIFIER (B)(6)). THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR MDR REPORT SUBMISSIONS. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PLAINTIFF¿S ATTORNEY: THE DEATH CERTIFICATE INDICATED THAT THE PATIENT¿S CAUSE OF DEATH WAS ¿SEPSIS¿ DUE TO OR AS A CONSEQUENCE OF ¿ACUTE OR CHRONIC RESPIRATORY FAILURE,¿ DUE TO OR AS A CONSEQUENCE OF ¿FALLOPIAN TUBE DAMAGE,¿ DUE TO OR AS A CONSEQUENCE OF ¿COPD AND OSA.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AND SEPTIC SHOCK, AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 6 WEEKS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED PELVIC ABSCESS IS STILL UNKNOWN.

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 FOR FIBROIDS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND SUPPLEMENTAL HOSPITAL MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THERE WAS SOME DIFFICULTY PLACING TROCARS DUE TO DENSE INTRA-ABDOMINAL ADHESIONS. PERTINENT FINDINGS INCLUDED ADHESIONS OF THE BOWEL AND OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2013 THE PATIENT PRESENTED WITH LEAKING FLUID FROM HER VAGINA. A CYSTOSCOPY WAS PERFORMED WITH BILATERAL RETROGRADE PYELOGRAPHY. NO URINARY INJURY WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY WAS INITIATED BUT THEN ABANDONED DUE TO ADHESIONS. ON (B)(6) 2013, AN EXPLORATORY LAPAROTOMY WAS THEN PERFORMED. THE BOWEL WAS FOUND TO BE DENSELY ADHERENT TO THE UPPER ANTERIOR ABDOMINAL WALL. PELVIC ABSCESSES WERE IDENTIFIED AND

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 ALLOGRAFT COLPOPEXY, CYSTOCELE REPAIR, TVT MID URETHRAL TAPE WITH CYSTOSCOPY FOR TOTAL VAGINAL PROLAPSE WITH SEVERE CYSTOCELE, RECTOCELE AND ENTEROCELE AND URINARY INCONTINENCE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. PER THE OPERATIVE REPORT, SURGICAL FINDINGS INCLUDED SIGNIFICANT ADHESIONS OF LOOPS OF SMALL BOWEL TO THE PELVIS, CUL-DE-SAC IN THE MIDLINE, AND RIGHT SIDE WALL. THE SURGEON PERFORMED THE LYSIS OF ADHESIONS ROBOTICALLY AND THE SACRAL COLPOPEXY AND TVT PORTIONS OF THE SURGERY. ANOTHER SURGEON PERFORMED THE RECTOCELE AND ENTEROCELE REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, PER A UROGYNECOLOGY OFFICE NOTE, THE FOLLOWING WAS NOTED, FEELING SORE IN ABD, REPORTED 'PURPLE LINES' NO EVIDENCE OF INFECTION, AND NO ANTIBIOTICS. IN ADDITION, THE PATIENT WAS USING IBUPROFEN FOR PAIN. THERE WAS NO OXYCODONE USE. 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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AN EMERGENCY CONVERSION TO OPEN SURGERY DUE TO LACK OF VISUALIZATION HAD OCCURRED. THE PATIENT EXPIRED DURING THE OPEN PROCEDURE. THERE WERE NO REPORTS OF ANY SYSTEM, INSTRUMENT(S) AND/OR ACCESSORY(IES) MALFUNCTION DURING THE COURSE OF THE 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 A PATIENT EXPIRED APPROXIMATELY FOUR WEEKS AFTER AN ESOPHAGECTOMY PROCEDURE WAS PERFORMED. THE ROBOTICALLY-ASSISTED SURGERY WAS CONVERTED TO OPEN SURGICAL TECHNIQUES, AS IT WAS STATED TO HAVE BEEN DIFFICULT FOR A NUMBER OF REASONS, ACCORDING TO THE SURGEON. THE COMPANY REPRESENTATIVE WAS INFORMED THAT THE PATIENT WAS DISCHARGED THREE WEEKS AFTER THE PROCEDURE FOR REHABILITATION. THE PATIENT THEN DIED A WEEK LATER OF WHAT THE HOSPITAL STAFF BELIEVES TO BE DUE TO A PULMONARY EMBOLISM/OTHER CARDIORESPIRATORY RELATED EVENT. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME.

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 LEFT NEPHRECTOMY PROCEDURE AND A UMBILICAL HERNIORRHAPHY ON (B)(6) 2012 FOR A LEFT RENAL NEOPLASM AND AN UMBILICAL HERNIA. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES AS A RESULT OF UNDERGOING THE DA VINCI SURGICAL PROCEDURE WHICH RESULTED WITH HIS DEATH ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. PER THE OPERATIVE REPORT, THE FOLLOWING WAS NOTED AFTER DISSECTION WAS PERFORMED, AT THIS POINT, IT WAS DECIDED TO PROCEED WITH DIVISION OF THE RENAL ARTERY AND WITH ELEVATION OF THE SUTURE, THE ARTERY WAS CUT BETWEEN THE TWO CLIPS, BUT ON ELEVATION BLEEDING DEVELOPED POSTERIORLY, WHICH WAS CONTROLLED INITIALLY WITH THE MARYLAND BIPOLAR IN NON COAGULATION MODE AND ATTEMPTS WERE MADE TO PLACE A SINGLE CLIP IN THE MAIN RENAL ARTERY HOWEVER, THIS WOULD NOT HOLD AND BLEEDING IMMEDIATELY ENSUED. THE PATIENT WAS URGENTLY CONVERTED TO AN OPEN THROUGH A LEFT PARAMEDIAN INCISION AND THE AORTA WAS CONTROLLED WITH DIGITAL PRESSURE. APPROXIMATELY 900 CC OF BLOOD WAS LOST DURING THIS RAPID CONVERSION. IT WAS NOTED THAT THE LEFT RE