da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2008 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE TRAUMA AND NERVE DAMAGE. NO FURTHER INFORMATION IS 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: ON MARCH 5, 2008, INTUITIVE SURGICAL WAS NOTIFIED PER A CUSTOMER PROVIDED LETTER: "THIS GENTLEMEN WAS DIAGNOSED WITH SEVERE MITRAL REGURGITATION. HE WAS ORIGINALLY EVALUATED FOR POSSIBLE CANDIDACY FOR TRANSMITRAL PERCUTANEOUS REPAIR. HE WAS TURNED DOWN DUE TO MITRAL ANATOMY. THE PT WAS REFERRED HERE FOR POSSIBLE ROBOTIC INTERVENTION AND AGREED TO PROCEED WITH THE SURGERY. INCIDENTLY, THE PT HAD A TEE WHICH REVEALED A VERY CALCIFIED VALVE WITH SEVERE MITRAL VALVE REGURGITATION AND FAIR OVERALL EJECTION FRACTION ABOUT 50%. THE PROCEDURE WAS PERFORMED ROBOTICALLY, INITIALLY WITH FAILURE OF THE MITRAL VALVE REPAIR NECESSITATING FURTHER BYPASS AND MITRAL RING ANNULOPLASTY, WHICH ALSO FAILED-NECESSITATING MITRAL VALVE REPLACEMENT. MULTIPLE TRANSFUSIONS WERE GIVEN INTRAOPERATIVELY (PRBC, 16 UNITS, PLASMA-14 UNITS, CRYO-40 UNITS, PLATELETS-90 UNITS). THE PT WAS IN THE OPERATING ROOM FROM 8:30AM-12 MIDNIGHT. ULTIMATELY, THE PT DEVELOPED LOW CARDIAC OUTPUT, CARDIOGENIC SHOCK AND UNCONTROLLABLE BLEEDING DIATHESIS. DEMISE AT 16:35."

da Vinci Surgical System — Injury 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 S PROSTATECTOMY PROCEDURE (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED A URETHRAL SPHINCTER INJURY AND HAD MISSING TISSUE. ACCORDING TO THE INFORMATION PROVIDED IN THE LEGAL COMPLAINT, THE PATIENT WAS NOTIFIED IN (B)(6) 2008 OF HIS INJURY AND UNDERWENT RECONSTRUCTIVE SURGERY AND PLACEMENT OF AN ARTIFICIAL URETHRAL SPHINCTER TO CONTROL HIS INCONTINENCE IN (B)(6) 2009. THE LEGAL COMPLAINT ALLEGES THAT FOLLOWING THE SURGERY, THE PATIENT IS IMPOTENT AND INCONTINENT. IT WAS STATED IN THE LEGAL COMPLAINT THAT THE PATIENT'S INJURIES MAY BE THE RESULT OF MEDICAL NEGLIGENCE OR CAUSED BY A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM.

da Vinci Surgical System — Injury 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 SI PROSTATECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND/OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury 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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC AND PERIAORTIC LYMPH NODE DISSECTION FOR ENDOMETRIAL CARCINOMA ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT HAD A 6-8 WEEK SIZE UTERUS WITH GROSSLY NORMAL ADNEXA BILATERALLY. EXCELLENT HEMOSTASIS WAS ACHIEVED AND CARE WAS TAKEN TO RETRACT BOTH URETERS LATERALLY. DESPITE THE MENTION OF EXCELLENT HEMOSTASIS, 200 ML OF BLOOD LOSS OCCURRED DURING THE PROCEDURE. DURING THE PELVIC LYMPH NODE DISSECTION GREAT CARE WAS TAKEN TO IDENTIFY THE OBTURATOR NERVE AND THE URETERS SO AS NOT TO INJURE THESE STRUCTURES. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION AND SUBSEQUENTLY DISCHARGED ON (B)(6) 2008 FOR A TOTAL STAY OF THREE DAYS. AN OPERATIVE NOTE DATED (B)(6) 2008 NOTED A COMPLICATED POSTOPERATIVE COURSE INCLUDING ILEUS, PELVIC AND ABDOMINAL FLUID COLLECTIONS, FEVER, LEUKOCYTOSIS AND JAUND

da Vinci Surgical System — Injury 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 ROBOTIC HYSTERECTOMY FOR DYSFUNCTIONAL UTERINE BLEEDING, FIBROID TUMORS AND OVARIAN CYSTS PROCEDURE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ON (B)(6) 2008, THE PATIENT UNDERWENT A ROBOTIC VAGINAL HYSTERECTOMY. IT WAS NOTED THAT THE SURGEON HAD DIFFICULTY REMOVING THE LARGE UTERUS. ON (B)(6) 2008, THE PATIENT WAS ADMITTED FOR VAGINAL CUFF BLEEDING AND WAS FOUND TO HAVE A VESICOVAGINAL FISTULA DURING SURGERY. ON (B)(6) 2008, THE PATIENT CONSULTED WITH A UROLOGIST AND IT WAS NOTED THAT THERE WAS LARGE AMOUNTS OF URINE PASSED VIA VAGINA. VCUG TESTING NOTED VESICOVAGINAL FISTULA. MD RECOMMENDED OPEN REPAIR OF FISTULA WITH OMENTAL INTERPOSITION. ON (B)(6) 2008, PATIENT WENT INTO SURGERY FOR VESICOVAGINAL FISTULA REPAIR FOLLOW UP VISIT NOTED NO LEAKAGE PER VAGINA. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. NO FURTHER CLINIC 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: IN 2008, AFTER A SINGLE VESSEL SMALL THORACOTOMY DA VINCI S PROCEDURE, THE PATIENT EXPIRED WHILE WEANING OFF OF BYPASS. PRIOR TO THE PROCEDURE, THE PATIENT APPEARED TO HAVE A HEPARIN REACTION AND EXPERIENCED A HYPOTENSIVE EVENT WITH A SYSTOLIC PRESSURE OF 39MM. THE SITE INITIATED A CARDIOPULMONARY BYPASS RUN AND COMPLETED THE PROCEDURE WITHOUT EVENT. WEAN FROM BYPASS WAS UNSUCCESSFUL AS PATIENT EXHIBITED STONE HEART CHARACTERISTICS. NO MALFUNCTION OF THE DAVINCI S SYSTEM WAS ALLEGED BY THE HOSPITAL, AND THE INFORMATION PROVIDED INDICATES THAT THIS EVENT IS RELATED TO THE INHERENT RISKS ASSOCIATED WITH BYPASS AND THE PATIENT'S MEDICAL HISTORY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON JUNE 25, 2012, A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2008, PROVIDED INTUITIVE SURGICAL INFORMATION REGARDING THEIR POSTSURGICAL EXPERIENCE. THE PATIENT INDICATED THAT THEIR PROCEDURE WAS SUCCESSFUL IN REMOVING CANCER, AS THE PATIENT IS STILL CANCER FREE 4.5 YEARS AFTER THE PROCEDURE. HOWEVER, THE PATIENT ALLEGES NUMEROUS COMPLICATIONS THROUGH THE CASE: THE PATIENT CLAIMS THAT DURING THE SURGERY THERE WAS DAMAGE TO HIS VEIN, A SCRATCH ON HIS RIGHT EYE AND DAMAGE TO HIS PENIS CAUSING A CLOSED URETHRA. THE PATIENT REPORTED THAT THE PROCEDURE LEFT HIM INCONTINENT, AND IMPOTENT. THE PATIENT ALSO REPORTED THAT THE PROCEDURE HAS CAUSED HIM TO HAVE PAIN DURING ORGASM, AND HAVE PAIN IN THE LEGS AND GROIN. THE PATIENT ALSO ALLEGES THAT A SECOND PROCEDURE WAS REQUIRED TO REPAIR A GROIN HERNIA. THE PATIENT ALLEGES THAT HE MIGHT NOT HAVE UNDERWENT SURGERY HAD THEY SEEN THE RECOMMENDATION FROM (B)(4), WHICH HE CLAIMS, SUGGESTS MEN NOT GET SCREENED FOR PROSTATE CANCER PARTLY BECAUSE IT RESULTS IN OVERTREATMENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER (B)(6)) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON 04/23/2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM 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: ON JANUARY 17, 2008, INTUITIVE SURGICAL WAS NOTIFIED THAT FOLLOWING A DA VINCI S HYSTERECTOMY SURGICAL PROCEDURE, THE PT SUFFERED FROM SEPSIS AND EXPIRED FOUR DAYS POST DA VINCI ASSISTED SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADD'L INFO RECEIVED FROM REPORTER ON 01/29/2015. IN HOSPITAL A MONTH OUT 4 HOURS. HAD TO BE READMITTED GIVEN 8 PINTS OF BLOOD. I HAVE HAD TO HAVE SIX ADD'L OPERATIONS. I HAD DA VINCI ROBOTIC SURGERY TO REMOVE MY PROSTATE. DURING MY ROBOTIC SURGERY, THE ROBOT STARTED BACK UP BY ITSELF AND DID A LOT OF DAMAGE TO MY INTERNAL ORGANS. I WAS OPERATED BY A SURGEON THAT RECOMMENDED THE USE OF THE DA VINCI ROBOT. I REMAINED IN THE HOSPITAL OF 30 DAYS. AFTER MY OPERATION, I WAS GIVEN OVER 18 PINTS OF WHOLE BLOOD. ONE OF THE INTERNS THAT HELPED THE SURGEON TOLD ME THAT DURING THE SURGERY THE ROBOT WAS NOT WORKING CORRECTLY AND THAT SURGEON WENT AHEAD AND USED IT ANYWAY. WHAT RESULTED IS THAT THERE WERE A LOT OF DAMAGES TO MY INTERNAL ORGANS AND I HAVE HAD TO HAVE AT LEAST ONE OPERATION A YEAR EVER SINCE I HAD THE DA VINCI ROBOTIC SURGERY. IN THE PAST SIX YEARS I HAVE HAD 6 MAJOR OPERATIONS TO REPAIR DAMAGES THAT THE DA VINCI ROBOT CAUSED TO MY INTERNAL ORGANS. AS A DIRECT RESULT OF ALMOST DYING TWICE, STAYING IN THE HOSPITAL FOR FIVE WORKS, NOT EATING, NOT WALKING. I LOST 30 POUNDS AND I WAS LEFT WITH SEVERE ANXIETY ATTACKS AND MAJOR DEPRESSION FOR WHICH I NOW HAVE TO SEE A PSYCHIATRIST .

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 11/16/2016, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA VOLUNTARY REPORT MW5065724 WITH THE FOLLOWING EVENT DESCRIPTION: I LIKE SCORES OF OTHER CLINIC PATIENTS, WAS PERMANENTLY HARMED WITH DAVINCI ROBOT. ALTHOUGH I WAS GIVEN 5500 CC OF COLLOIDS AND CRYSTALLOID DURING MY SURGERY, THE COPY AND PASTE OF OP NOTE REPORTED 150 CC BLOOD LOSS AND NO COMPLICATIONS. STATED HE HAD TROUBLE, COULD NOT SEE ANYTHING, USED A TEMPLATE, HAD TO GUESS LEAVING ANASTOMOSIS, BACTEREMIA, PEYRONIE'S DISEASE, IMPOTENT, AND TOTALLY INCONTINENT. THE GENERIC OP REPORT STATES, NO COMPLICATIONS. MY BLADDER WAS STAPLED INSTEAD OF THE FINE BASEBALL STITCHING: ADVERTISED BY THE SURGEON. A PERMANENTLY HARMED PT., INFORMED ME THAT WE WERE TEST SUBJECTS WITHOUT OUR CONSENT, BEFORE HE WAS SILENCED WITH A PAYOFF BY THE CLINIC. THE CLINIC REFUSED TO PROVIDE ME SERIAL NUMBER OR DESCRIBE THE DA VINCI FAILURES WHICH CAUSED MY HARM. I LOST MY JOB AS A (B)(6) PILOT. I AM NOW DISABLED AND IN CONSTANT PAIN. ON 12/05/2016, ISI CONTACTED THE PATIENT AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: ON (B)(6) 2008, THE PATIENT UNDERWENT A DA VINCI-ASSISTED RADICAL PROSTATECTOMY AND WAS ALLEGEDLY LEFT DISABLED

da Vinci Surgical System — Injury 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 (B)(6) 2008. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURY TO HIS BLADDER AND OTHER ORGANS RESULTING IN URINARY INCONTINENCE AND ERECTILE DYSFUNCTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER (B)(6)) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON (B)(6) 2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FROM THE

da Vinci Surgical System — Injury 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 SI PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL RECORDS FROM PRIMARY CARE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . ON (B)(6) 2007 PATIENT PRESENTED WITH SYMPTOMS OF URINE LEAKAGE. ANTEGRADE URETERAL STENT WAS PLACED AND LEAKAGE STOPPED. PATIENT DISCHARGED HOME. SUBSEQUENT HEALTH REPORTS SHOW PROBLEMS WITH ONGOING INCONTINENCE, URETERAL STRICTURE, AND ERECTILE DYSFUNCTION.

da Vinci Surgical System — Injury 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, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED AN INJURY TO HER SMALL BOWEL DURING THE SURGICAL PROCEDURE. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE PATIENT DEVELOPED A PELVIC ABSCESS POST-OPERATIVELY. THE PATIENT'S MEDICAL RECORDS STATE THE PATIENT UNDERWENT A ROBOTIC ASSISTED HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND A BILATERAL PELVIC AND PARAAORTIC LYMPHADENECTOMY PROCEDURE. AFTER CLOSURE AND INSPECTION OF THE VAGINAL CUFF, A SMALL "SEROTOMY" WAS FOUND IN THE SIGMOID COLON. THE "SEROTOMY" WAS REPAIRED WITH SUTURES. UPON COMPLETION OF THE SURGICAL PROCEDURE, THE SURGEON STATED IN THE OPERATIVE REPORT THAT THERE WERE NO COMPLICATIONS AND THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY WITH ORAL PAIN MEDICATIONS. AT AN UNSPECIFIED TIME RIGHT AFTER THE SURGERY WAS COMPLETED, THE PATIENT DEVELOPED ABDOMINAL DISTENSION FROM ACCUMULATION OF LYMPHATIC FLUID. AFTER THE FIRS

da Vinci Surgical System — Injury 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 PROSTATECTOMY PROCEDURE ON (B)(6) 2007 WHO ALLEGEDLY EXPERIENCED POST-SURGICAL COMPLICATIONS, INCLUDING BOWEL OBSTRUCTION ON POST OPERATIVE DAY 3 AND HAD BLADDER LEAKAGE FROM HIS PROSTATECTOMY, WHICH WAS TREATED WITH A BLADDER SLING. THE PATIENT HAD MULTIPLE HOSPITAL VISITS TO TREAT HIS BOWEL OBSTRUCTION AND ULTIMATELY UNDERWENT 2 ADDITIONAL SURGERIES ON (B)(6) 2011 AND (B)(6) 2011. IT WAS ALSO ALLEGED THAT THE ROBOT MALFUNCTIONED WHICH RESULTED IN INTERNAL BURNS AND NERVE DAMAGE. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE (OP) REPORTS FOR THE DA VINCI SURGERY AS WELL AS ADDITIONAL MEDICAL RECORDS; HOWEVER, THE OPERATIVE REPORTS FOR THE 2 SUBSEQUENT SURGERIES WERE NOT PROVIDED. ACCORDING TO AN OPERATIVE REPORT DATED (B)(4) 2007, THE PATIENT UNDERWENT A DA VINCI ROBOTIC-ASSISTED RADICAL PROSTATECTOMY AND RIGHT PELVIC LYMPHADENECTOMY FOR PROSTATE CANCER. PATIENT WAS DIAGNOSED WITH ADENOCARCINOMA OF THE PROSTATE. 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-

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 AND UMBILICAL HERNIA REPAIR ON (B)(6) 2007. 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, THE PATIENT UNDERWENT THE DA VINCI SURGICAL PROCEDURE WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. PER THE MEDICAL RECORDS, THE PATIENT WAS STARTED ON LEVAQUIN ON POST-OP DAY 2 FOR POSSIBLE CELLULITIS. SHE HAD SLOW RETURN OF BOWEL FUNCTION. THE PATIENT WAS ONLY PASSING SMALL AMOUNTS OF GAS THROUGHOUT THE FIRST FEW DAYS OF HER HOSPITAL COURSE AND FELT VERY UNCOMFORTABLE GOING HOME. HER BOWEL REGIMEN WAS INITIATED ORALLY AND RECTALLY ON POST-OP DAY 4 AND BEGAN TO PASS GAS ON POST-OP DAY 5. SHE HAD A SMALL BOWEL MOVEMENT AND BY POST-OP DAY 6 FELT VERY COMFORTABLE GOING HOME. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. ON (B)(6) 2008, THE PATIENT WAS SEEN IN AN ER FOR ABDOMINAL PAIN. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS

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) 2015, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BJU INTERNATIONAL JOURNAL ARTICLE TITLED, PERIOPERATIVE AND RENAL FUNCTIONAL OUTCOMES OF ELECTIVE ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN) FOR RENAL TUMOURS WITH HIGH SURGICAL COMPLEXITY (VOLPE ET AL., 2014). THE JOURNAL ARTICLE NOTES SEVERAL OPERATIVE COMPLICATIONS. REFER TO MFR. REPORT 2955842-2015-00706 (PATIENT IDENTIFIER RC20155000211) WHICH WAS INITIALLY SUBMITTED TO THE FDA AND BEFORE THE SITE AND SURGEON NAMES RELATED TO THE SURGICAL PROCEDURES WERE KNOWN. ON 04/23/2015, A CORRESPONDENCE CONTACT FOR THE JOURNAL ARTICLE PROVIDED THE SITE AND SURGEON NAMES OF THE OPERATIVE COMPLICATIONS NOTED WITHIN THE JOURNAL ARTICLE. IN THE RESULTS SECTION OF THE BJUI JOURNAL ARTICLE, THE FOLLOWING IS STATED: IN ALL, 44 RAPNS FOR RENAL TUMOURS WITH PADUA SCORES OF > 10 WERE INCLUDED IN THE ANALYSIS; 23 TUMOURS (52.3%) WERE CT1B. THE MEDIAN (INTERQUARTILE RANGE; RANGE) OPERATIVE TIME, ESTIMATED BLOOD LOSS AND WARM ISCHAEMIA (WIT) WERE 120 (94, 132; 60-230) MIN, 150 (80, 200; 25- 1200) ML AND 16 (13.8, 18; 5-35) MIN, RESPECTIVELY. TWO INTRAOPERATIVE COMPLICATIONS OCCURRED (4.5%); ONE INFERIOR VENA CAVAL INJURY AND ONE BLEED FR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ISI RECEIVED A REPORT THAT DURING A DA VINCI TOTAL HYSTERECTOMY PROCEDURE, THE SURGEON REMOVED HIS HANDS FROM THE MASTER TOOL MANIPULATOR (MTM); AT THE SAME TIME, ALL EVIDENCE INDICATES THE SURGEON DID NOT REMOVE HIS HEAD FROM THE SURGEON'S CONSOLE, WITH THE RESULT THAT THE PT SIDE MANIPULATOR ("PSM") REMAINED ENGAGED. UPON REMOVAL OF THE SURGEON'S HANDS FROM THE MTM, THE PSM DROPPED SHARPLY, CAUSING THE SCISSORS INSTRUMENT, WHICH WAS INSTALLED ON THE PSM TO INADVERTENTLY PIERCE THE PT'S UTERER. THE UTERER WAS, THEREAFTER, STENTED AND SUCCESSFULLY SUTURED BY A UROLOGIST.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: I HAD A HYSTERECTOMY IN 2007 USING THE DAVINCI INSTRUMENT. A SCREW FELL OUT OF THE INSTRUMENT INTO MY ABDOMEN WHICH RESULTED IN THE SURGERY TAKING 3 ADDITIONAL HOURS WHEREAS THE SURGEON MADE THE DECISION TO LEAVE THE SCREW IN MY ABDOMEN. SINCE THE SURGERY, THE SCREW REMAINS -6 WEEKS POST OP-, I HAVE HAD 2 BOUTS OF GASTROPARESIS WHICH REQUIRED A RE-HOSPITALIZATION- GASTROPARESIS CONTINUES AT 6 WEEKS POST OP-, VAGINAL BLEEDING -CONTINUES-, LEFT LEG NUMBNESS AND DELAYED WOUND HEALING-CONTINUES 6 WEEKS POST OP-. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: HYSTERECTOMY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT UNDERWENT ROBOTIC TECAB (TOTALLY ENDOSCOPIC CORONARY ARTERIES BYPASS) WITH 2 INTERNAL MAMMARY ARTERIES, USING THE DA VINIC S ROBOT AND COALESCENT "U" CLIPS TO FACILITATE DISTAL ANASTOMOSES, ON A BEATING HEART. ON CORONARY ANGIOGRAPHY 5 DAYS LATER, THERE WAS 80% STENOSIS OF ONE DISTAL ANASTOMOSIS, AND 40% STENOSIS OF ANOTHER.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ATTEMPTED TECAB (TOTALLY ENDOSCOPIC CORONARY ARTERY BYPASS) SURGERY USING THE DEVINIC S ROBOT AND FACULATED BY THE COALESENT U CLIP ON A BEATING HEART. ONLY 2 OUT OF 4 ARTERIES WERE BYPASSED. PT ARRESTED AT THE KIND OF THE PROCEDUSE. CPR WAS INITIATED AND THE CHEST OPENED . PT WAS CONNECTED TO CADIOPULOMONARY BYPASS AND ADDITIONAL BYPASS GRAFTS PERFORMED. PT DIED ON THE OPERATING ROOM 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 IN (B)(4) THAT THE SIDE RAIL WAS DAMAGED ON WELDING.

da Vinci Surgical System — Injury 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 (B)(6) 2007. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HERNIA AND LIFE THREATENING INFECTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A JOURNAL ARTICLE BY COOPER ET AL TITLED, UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS. IN THIS ARTICLE, THE AUTHORS REPORTED COMPLICATIONS REPORTED IN MAUDE DATABASE OR LEXISNEXIS, AND PACER (PUBLIC ACCESS TO COURT ELECTRONIC RECORDS) FROM JANUARY 1, 2000 TO AUGUST 1, 2012. ACCORDING TO A REPORTED INJURY IN THE ARTICLE, A PATIENT SUSTAINED NERVE DAMAGE AFTER UNDERGOING A PROLONGED UNSPECIFIED DA VINCI SURGICAL PROCEDURE ON (B)(6) 2007. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE HOSPITAL NAME, DA VINCI SYSTEM SERIAL , AND TYPE OF PROCEDURE INVOLVED WITH THIS COMPLAINT WERE NOT INCLUDED IN THE ARTICLE. ARTICLE INFORMATION: TITLE: UNDERREPORTING OF ROBOTIC SURGERY COMPLICATIONS AUTHORS: MICHOL A. COOPER, ANDREW IBRAHIM, HEATHER LYU, MARTIN A. MAKARY PUBLISHED DATE: 08/27/2013 LINK: (B)(4).

da Vinci Surgical System — Injury 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury 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 SI TOTAL LAPAROSCOPIC HYSTERECTOMY/BILATERAL SALPINGO-OOPHORECTOMY FOR DYSFUNCTIONAL UTERINE BLEEDING, METRORRHAGIA AND CHRONIC PELVIC PAIN ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH 2 OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL - (B)(6) 2007. DISCHARGE SUMMARY (B)(6) 2007, GYN CONSULTATION (B)(6) 2007, NURSING ADMISSION H&P (B)(6) 2007, PROGRESS NOTE (B)(6) 2007. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER PLACEMENT OF A UTERINE MANIPULATOR, DEVELOPMENT OF A PNEUMOPERITONEUM THROUGH AN INFRAUMBILICAL INCISION THE ROBOT WAS DOCKED TO THE PREVIOUSLY PLACED PORTS. THE HYSTERECTOMY WAS CARRIED OUT IN A STANDARD FASHION. THE LATERAL PELVIC LIGAMENTS TO THE UTERUS WERE CAUTERIZED AND CUT BILATERALLY USING THE CUTTING BIPOLAR AND THE SPATULA. THE BLADDER FLAP WAS DEVELOPED AND THE UTERINE VESSELS SKELETONIZED BILATERALLY. A CIRCUMFERENTIAL COLPOTOMY WAS CARRIED OUT USING SPATULA AND ELECTROCAUTERY AND

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AT THE END OF A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE THE SURGICAL STAFF NOTICED A "DRIED OR BURN-LIKE" AREA AROUND THE CAMERA PORT INCISION, APPROX 2MM IN WIDTH. THE DAMAGED SKIN HAD TO BE CUFF OFF IN ORDER TO CLOSE THE INCISION. NO VISUAL DAMAGE NOR SIGNS OF MELTING WERE OBSERVED ON THE CANNULA ACCESSORY USED IN CONJUNCTION WITH THE CAMERA.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDWATCH UF/IMPORTER REPORT WAS REC'D AT ISI ON SEPTEMBER 28, 2007. INTUITIVE SURGICAL WAS PREVIOUSLY INFORMED OF THIS EVENT ON JULY 25, 2007. IT WAS ALSO REPORTED THAT THE PT WAS LATER BROUGHT BACK TO THE OR IN 2007, TO DRAIN CLOTS WHICH HAD FORMED, HOWEVER, THE DA VINCI SYS WAS NOT USED FOR THIS PROCEDURE. THE PT DIED FOUR DAYS POST DA VINCI ASSISTED SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative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

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/08/2010, ISI RECEIVED VOLUNTARY MEDWATCH (B)(4) FROM THE FDA DEPARTMENT OF HEALTH AND HUMAN SERVICES REPORTING THE FOLLOWING: VOLUN 01-FEB-2010: MY NAME IS (B)(6). I AM THE PERSONAL REP OF THE ESTATE OF (B)(6), ON (B)(6) 2007, MY MOTHER HAD A DAVINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT (B)(6) MEDICAL CENTER IN (B)(6). IT IS MY UNDERSTANDING THAT DURING THIS EVENT, DR (B)(6) LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULONARY ARREST AND NEAR EXSAGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS A MAUDE ADVERSE EVENT ASSOCIATED WITH THE DAVINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN: (B)(6) MD. FACILITY: (B)(6) MEDICAL CENTER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED, INCLUDING INFORMATION RELATED TO THE FIELDS IN (B)(6).

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON MARCH 12, 2010, ISI RECEIVED MAUDE EVENT REPORT (B) (4) WITH THE FOLLOWING EVENT DESCRIPTION: MY NAME IS XXX. I AM THE PERSONAL REP OF THE ESTATE OF XXX ON XX XX 2007, MY MOTHER HAS A DA VINCI ROBOT ASSISTED LAPAROSCOPIC HYSTERECTOMY AT XXX MEDICAL CENTER IN XXX. IT IS MY UNDERSTANDING THAT DURING THIS EVENT DR XXX LOST VISUALIZATION AND THE INSTRUMENT ON THE ROBOT CUT THE RIGHT COMMON ILIAC ARTERY LEADING TO HEMORRHAGE, CARDIOPULMONARY ARREST AND NEAR EXSANGUINATION. THE INFO I HAVE BEEN PROVIDED WITH INDICATES THAT THIS MAY HAVE BEEN REPORTED TO THE FDA AS AN MAUDE ADVERSE EVENT ASSOCIATED WITH THE DA VINCI SURGICAL ROBOT. I HAVE NOT BEEN ABLE TO LOCATE SUCH A REPORT DURING MY ONLINE SEARCH. PHYSICIAN XXX. MEDICAL FACILITY XXX. NO ADDITIONAL INFORMATION WAS PROVIDED.

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON 04/11/2013 WHILE READING A DRAFT RESEARCH PAPER ENTITLED "STEREOTACTIC BODY RADIATION THERAPY FOR HEPATOCELLULAR CARCINOMA; PROGNOSTIC FACTORS OF LOCAL CONTROL, OVERALL SURVIVAL, AND TOXICITY"; AN ACCURAY EMPLOYEE BECAME AWARE OF AN ADVERSE EVENT. THIS STUDY IS PARTIALLY FUNDED BY ACCURAY. THE PAPER REPORTS THAT THREE MONTHS AFTER A CYBERKNIFE TREATMENT FOR A TUMOR IN THE LIVER, ONE PATIENT EXPERIENCED A GRADE 4 GASTRIC ULCER, RESULTING IN A DIGESTIVE HEMORRHAGE, WHICH WAS TREATED. THE PAPER REPORTS FOLLOWING THE ADVERSE OUTCOME "TREATMENT PLANS WERE REVIEWED AND STRICT CONSTRAINTS WERE DEFINED FOR SUBSEQUENT TREATMENTS." THE PRINCIPLE INVESTIGATOR CONFIRMED THE CYBERKNIFE DID NOT MALFUNCTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED VOLUNTARY REPORT (B)(4) FROM THE FDA WITH THE FOLLOWING EVENT DESCRIPTION: DA VINCI ROBOT WAS USED TO PERFORM HYSTERECTOMY. DURING PROCEDURE, LEFT URETER CUT, TOXIC FLUID OVERLOAD AND RESULTING CARDIAC INSUFFICIENCY OCCURRED. SIX DAYS LATER, A CARDIAC CATH PERFORMED AND REVEALED DAMAGE DURING HYSTERECTOMY, FOLLOWING DAY, SURGERY TO REPAIR URETER WAS PERFORMED.

da Vinci Surgical System — Injury 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 RADICAL PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. SUBSEQUENT MEDICAL REPORTS ARE ALSO SUBMITTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION ON (B)(6) 2007 THE PATIENT PRESENTED WITH SYMPTOMS OF BLADDER SPASMS AND BLOODY URINE. HE WAS FOUND TO HAVE EXTRAPERITONEAL URINE EXTRAVASATION AT THE ANASTOMOSIS. PROLONGED CATHETER DRAINAGE WAS RECOMMENDED. HE DEVELOPED A URINARY TRACT INFECTION AND WAS TREATED WITH LEVAQUIN. SERUM CREATININE WAS FOUND TO BE ELEVATING. ON (B)(6) 2007 THE PATIENT PRESENTED WITH FEVER AND CHILLS AND WAS FOUND TO HAVE ANOTHER URINARY TRACT INFECTION WITH BACTEREMIA. HE ALSO DEVELOPED PALPITATIONS AND SUPRAVENTRICULAR TACHYCARDIA DUE TO MEDICATION WITHDRAWAL. ON (B)(6) 2007 THE PATIENT UNDERWENT CT GUIDED DRAINAGE OF A PELVIC FLUID COLLECTION WITH OLD BLOOD OBTAINED. ON (B)(6) 2007 THE PATIENT UNDERWENT AN OPERATIVE CYSTOGRAM WITH FOLEY CATHETER EXCHANGE. A HOLE W

da Vinci Surgical System — Injury 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 ROBOTIC RADICAL PROSTATECTOMY PROCEDURE FOR PROSTATE CANCER ON (B)(6) 2007. ACCORDING TO THE OPERATIVE REPORT, A ROBOTIC MALFUNCTION OCCURRED DURING THE POSTERIOR BLADDER NECK DISSECTION CAUSING THE SYSTEM TO REQUIRE REBOOTING ABOUT 20 TIMES. THE SURGEON INDICATED, IT WOULD TAKE APPROXIMATELY 30-45 SECONDS TO REBOOT THE ROBOT AFTER EACH ONE OF THE MANUAL FAULT OVERRIDES. THERE WERE ALSO TIMES WHERE THE ROBOT WOULD ACTUALLY TAKE 5 MINUTES TO REBOOT AND WE WOULD HAVE TO GET THE REPRESENTATIVE ON THE TELEPHONE TO DO THIS. DURING BLADDER NECK RECONSTRUCTION, THE SURGEON INDICATED, DUE TO THE ROBOT MALFUNCTION, SOME OF THESE SUTURES TORE THROUGH THE POSTERIOR BLADDER NECK. THE SURGEON ENDED UP PERFORMING ANOTHER FIGURE-OF-EIGHT SUTURE TO RECONSTRUCT THE BLADDER NECK A LITTLE BIT FURTHER. IN THE OPERATIVE REPORT, A RECTO-SIGMOID LACERATION WAS ALSO DISCOVERED AND REPAIRED. THE PATIENT WAS DISCHARGED ON (B)(6) 2007. THERE WERE NO REPORTED SEQUELAE. ON 08/28/2014, ISI CONTACTED THE SITE'S RISK MANAGEMENT DEPARTMENT. THE RISK MANAGER REVIEWED THE INCIDENT RE

da Vinci Surgical System — Injury 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 S RADICAL HYSTERECTOMY WITH BILATERAL, SALPINGO-OOPHORECTOMY (WERTHEIM OPERATION), AND BILATERAL PELVIC AND PARAAORTIC LYMPHADENECTOMY WITH ROBOTIC LAPAROSCOPIC APPROACH, PARTIAL VULVECTOMY (POSTERIOR PERINEUM), EXCISION OF POSTERIOR VULVAR LESION FROM THE RIGHT VULVA FOR CERVICAL CANCER, STAGE 1B-1, AND VULVAR CARCINOMA IN SITU AND VULVAR LESION ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007, (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2013). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H &P): (B)(6) 2007; (B)(6) 2013; DISCHARGE SUMMARIES: (B)(6) 2007, (B)(6) 2008, (B)(6) 2013 UROLOGY CONSULTATION/EVALUATION/FOLLOW-UP (F/U): (B)(6) 2008, (B)(6) 2009, (B)(6) 2010, (B)(6) 2012, (B)(6) 2013. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. INTRAOPERATIVELY, AN EEA SIZER WAS PLACED IN THE VAGINA, A PNEUMOPERITONEUM CREATED THROUGH A LEFT UPPER QUADRANT INCISION AND A PARA-AORTIC AND BILATERAL PE

da Vinci Surgical System — Injury 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, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2007. THE DOCUMENTATION PROVIDED STATES THAT THE PATIENT DEVELOPED A PSOAS ABSCESS AFTER UNDERGOING THE SURGICAL PROCEDURE. THE OPERATIVE REPORT RELATED TO THE DA VINCI SI RADICAL PROSTATECTOMY PROCEDURE WAS NOT PROVIDED AND NO ADDITIONAL DETAILS ARE AVAILABLE AT THIS TIME. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, TWO WEEKS POSTOP THE PATIENT REPORTED COMPLAINTS OF PAIN IN HIS LEFT HIP WHICH PROGRESSIVELY GOT WORSE. ON (B)(6) 2007, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR REPORTED COMPLAINTS OF LEFT PELVIC PAIN, HIP PAIN, AND FEVER. A CT SCAN REVEALED THAT THE PATIENT HAD AN ILIOPSOAS ABSCESS. THE PATIENT'S MEDICAL RECORDS STATED THAT A FISTULOGRAM WAS PERFORMED AND A FISTULA WAS FOUND BETWEEN THE COLON AND THE ABSCESS. ON (B)(6) 2007, THE PATIENT UNDERWENT A PARTIAL COLON RESECTION WITH ANASTOMOSIS PROCEDURE AND DRAINAGE OF THE ABSCESS. ON (B)(6) 2007, THE PATIENT WAS DISCHARGED HOME WITH ANTIBIOTICS, PAIN PILLS, AND SOME OUTPATIENT THERAPY. THE PATIENT'S DIS

da Vinci Surgical System — Injury 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 S PROSTATECTOMY PROCEDURE ON (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT IS IMPOTENT AND INCONTINENT. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury 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 (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury 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 (B)(6) 2007. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2007. THE PROVIDED INFORMATION ALLEGES THAT THE PATIENT SUSTAINED A PUNCTURED BLADDER AND INCONTINENCE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. NO OTHER INFORMATION WAS PROVIDED. INFORMATION RELATED TO THE DA VINCI SYSTEM WAS NOT PROVIDED; THEREFORE, THE MODEL AND SERIAL ARE NOT KNOWN.

da Vinci Surgical System — Injury 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 S TOTAL HYSTERECTOMY, BSO WITH LYSIS OF ADHESIONS AND REPAIR OF A SMALL UMBILICAL HERNIA ON (B)(6) 2007. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT (OP) AND THE SUBSEQUENT IMAGING AND STENT PLACEMENT REPORTS, AND THE OP FOR THE PATIENT'S URETERAL REIMPLANTATION. NO MEDICAL HISTORY REGARDING THE PATIENT WAS PROVIDED TO ISI. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. AFTER EXTENSIVE LYSIS OF OMENTAL ADHESIONS TO AN UMBILICAL HERNIA, THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL CAUTERY AND DIVISION OF THE INFUNDIBULOPELVIC, ROUND, AND BROAD LIGAMENTS. THE UTERINE ARTERIES AND THE CARDINAL LIGAMENTS WERE CAUTERIZED AND DIVIDED. THE COLPOTOMY WAS PERFORMED AGAINST A V-CARE COLPOTOMY CUP, THE UTERINE STRUCTURES REMOVED THROUGH THE VAGINA. THE VAGINAL CUFF WAS SUTURED CLOSED, THE EXISTING FACIAL DEFECT IN THE ANTERIOR ABDOMINAL WALL CLOSED, AND THE SURGERY COMPLETED WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE FOLEY WAS DRAINING BLUE URINE FROM IV INDIGO CARMINIE INDICATING GOOD URI

da Vinci Surgical System — Injury 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 SI RADICAL RETROPUBIC PROSTATECTOMY FOR LOCALIZED PROSTATE CANCER ON (B)(6) 2007. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS ((B)(6) 2007). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL: (B)(6) 2007, INFECTIOUS DISEASE CONSULTATION (B)(6) 2007, GENERAL SURGERY CONSULT (B)(6) 2007, PULMONOLOGY CONSULT (B)(6) 2007, HEMATOLOGY CONSULT (B)(6) 2007, NEUROLOGY CONSULT (B)(6) 2007, NEPHROLOGY CONSULT (B)(6) 2007, DISCHARGE SUMMARY (B)(6) 2007 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. UPON ENTERING INTO THE ABDOMEN AND CREATING A PNEUMOPERITONEUM NO SIGNIFICANT ADHESIONS WERE NOTED. SUBSEQUENTLY, A ROUTINE RADICAL PROSTATECTOMY WAS PERFORMED WITHOUT INCREASED DIFFICULTY OR NOTED INJURIES TO ADJACENT STRUCTURES. THE WOUND AREA LOOKED TO HAVE NO APPARENT INJURY TO THE BLADDER OR BOWEL. ON (B)(6) 2007 - THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY WITH EXTENSIVE ADHESIOLYSIS, SMALL BOWEL RESECTION AND REPAIR OF MULTIPLE ENTE

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 JUNE 10, 2008, INTUITIVE SURGICAL WAS NOTIFIED OF A PT DEATH PER LITIGATION DOCUMENTATION WHICH REPORTS THE FOLLOWING: IN 2007, FIVE DAYS AFTER UNDERGOING A DA VINCI RADICAL PROSTATECTOMY PROCEDURE, A PT UNDERWENT EMERGENCY EXPLORATORY LAPAROTOMY AND INTER ALIA. BOWEL NECROSIS WITH SEPTICEMIA WAS OBSERVED AND SAID TO BE THE RESULT OF AN INTEROPERATIVE MESENTERY TEAR. SIX CENTIMETERS OF CONTINUOUS STITCH WAS APPLIED TO REPAIR THE AFFECTED AREA, HOWEVER, THE PT EXPIRED.

da Vinci Surgical System — Injury 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 (B)(6) THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AFTER HAVING DA VINCI ROBOTIC SURGERY FOR PROSTATE REMOVAL, I REMAINED IN THE HOSPITAL FOR 33 DAYS AND WAS GIVEN 18 PINTS OF BLOOD. I ALMOST DIED TWICE BECAUSE OF INTERNAL BLEEDING AND OTHER COMPLICATIONS. THE SURGEON DID NOT EVEN COME TO SEE ME AFTER THE SURGERY. I SPOKE WITH AN INTERN THAT HELPED THE SURGEON WITH THE OPERATION AND HE TOLD ME THAT AT TIMES SOME OF THE ARMS FAILED TO DO WHAT IT SUPPOSED TO DO. ALSO, THE INTERN SAID THAT HE FELT THAT THE SURGEON DID NOT HAVE SUFFICIENT TRAINING TO PERFORM THE OPERATION. I HAD TO HAVE SEVEN MORE OPERATIONS TO CORRECT THE DAMAGE TO MY INTERNAL ORGANS BECAUSE OF THE DEFECTIVE DA VINCI ROBOT. IF A SURGEON DOES NOT HAVE THE TRAINING AND IF THE MFR (INTUITIVE SURGICAL SUPPLY) IS ALLOWED TO MANUFACTURE DEFECTIVE SURGICAL DEVICES SUCH AS THE DA VINCI ROBOT THEN THEY WILL END UP LIKE I DID AND THAT MEANS SLOWLY BLEEDING TO DEATH AND HAVING TO HAVE MORE EXTENSIVE SURGERIES TO REPAIR THE DAMAGES THAT WERE CAUSED TO ME BY THE USE OF THE DA VINCI ROBOT AND THE SURGEON.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6). RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE! DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(4)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED BECAUSE ON THE GLEANSON SCALE READING OF 6. DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR. (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOI