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 07/25/2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY AND CYSTOSCOPY PROCEDURE ON (B)(6) 2012 DUE TO A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING, UNRESPONSIVE TO MEDICAL MANAGEMENT. ONE DAY PRIOR TO THE PROCEDURE ((B)(6) 2012), SHE WAS DIAGNOSED WITH BACTERIAL VAGINITIS AND PLACED ON ANTIBIOTICS. ACCORDING TO THE OPERATIVE REPORT, THERE WERE NO REPORTS OF COMPLICATIONS DURING THE SURGICAL PROCEDURE. A CYSTOSCOPY WAS PERFORMED AND INDIGO CARMINE WAS CONFIRMED TO COME OUT BOTH URETERAL ORIFICES. THE SURGEON NOTED THAT THE PATIENT HAD A NORMAL PELVIS, NORMAL UPPER ABDOMEN AND HAD NORMAL FLOW INTO THE BLADDER OF URINE AFTER THE CASE FROM THE URETERS. THE BLADDER REPORTEDLY HAD GOOD INTEGRITY WITH NO LEAKS. THE PATIENT WAS TAKEN INTO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2012, SHE WAS AFEBRILE, VOIDING AND TOLERATING A REGULAR DIET. ON (B)(6) 2013, THE PATIENT WENT TO HER DOCTOR'S OFFICE WITH COMPLAINTS OF RECURRENT VAGINAL DISCHARGE AND POST COITAL BLEEDING. ON (B)(6) 2013, THE VAGINAL CUFF WAS NOTED TO BE NOT COMPLETELY

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 HYSTERECTOMY FOR ENDOMETRIAL CANCER, BILATERAL SALPINGO-OOPHORECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, RIGHT PERIO-AORTIC LYMPH NODE DISSECTION, PARTIAL OMENTECTOMY, AND CYSTOSCOPY ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS DISCHARGED FROM THE OPERATING ROOM AFTER THE SURGICAL PROCEDURES WERE COMPLETED AND THE PATIENT WAS ADMITTED FOR POST-OPERATIVE CARE. ON POST-OP DAY 1 ((B)(6) 2012), THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN DURING HER FIRST ATTEMPT TO USE THE BATHROOM AND WAS GIVEN TORADOL FOR PAIN. LATER THAT SAME DAY, THE PATIENT WAS GIVEN DILAUDID 1 MG IV FOR CONTINUED SEVERE ABDOMINAL PAIN. APPARENTLY, THE PATIENT'S ABDOMINAL PAIN PERSISTED WITH INCREASING INTENSITY AND SHE WAS NO LONGER ABLE TO AMBULATE. BY 6:12 PM THAT SAME DAY, THE PATIENT WAS STARTED ON IV PATIENT-CONTROLLED ANALGESIA (PCA) FOR SEVERE ABDOMINAL PAIN. THROUGHOUT THE NIGHT, THE PATIENT REPORTEDLY EXPERIENCED INCREASING ABDOMINAL PAIN AND RESPIRATORY DISTRESS. ON POST-OP DAY 2 ((B)(6) 2012) AT 6:45 AM, THE PATIENT UNDERWENT A CT SCAN OF HER CHEST, ABDOMEN, AND PELVIS 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT DEVELOPED A POST-OPERATIVE COMPLICATION OF A HERNIA.

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 HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY FOR DYSMENORRHEA AND FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. A CT SCAN REPORT FROM 2008 WAS INCLUDED AS WERE SIGNIFICANT NUMBERS OF MEDICAL RECORDS (NARRATIVES, OFFICE VISITS, LAB REPORTS) FROM THE FIVE YEARS PRECEDING HER SURGERY. POSTOP VISIT REPORTS WERE PROVIDED FOR (B)(6) 2012, (B)(6) 2012 AND (B)(6) 2012 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. DENSE ADHESIONS WERE NOTED DURING THE PROCEDURE AND THESE WERE TAKEN DOWN FROM THE UTERINE CERVIX WITH BLUNT AND SHARP DISSECTION UNTIL THE BLADDER WAS DISSECTED FREE OF THE UTERINE CERVIX. THE UTERUS WAS 140G. SEVERAL SMALL SECTIONS OF BLEEDING ALONG THE CUFF REMAINED HEMOSTATIC WITH ELECTROCAUTERY. THE PELVIS WAS COPIOUSLY IRRIGATED AND WAS FOUND TO BE HEMOSTATIC. THE DAVINCI WAS UNDOCKED AND A CYSTOSCOPY WAS PERFORMED. THE RIGHT URETER WAS NOTED TO BE FREELY EFFLUXING BLUE DYE, THE RESUL

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, ISI RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: WHILE TAKING DOWN ADHESIONS MADE INCIDENTAL HOLE IN SMALL BOWEL, SMALL BOWEL REPAIR DONE.

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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHEN THE SCRUB NURSE INSERTED THE MONOPOLAR CURVED SCISSORS INSTRUMENT AND BIPOLAR INSTRUMENT INTO THE PATIENT, AN AUDIBLE SOUND FROM THE ELECTRICAL SURGICAL UNIT (ESU) OCCURRED AND, THE ESU ACTIVATED WHEN THE CIRCULATING NURSE CONNECTED THE BIPOLAR AND MONOPOLAR CABLES TO THE ESU, CAUSING A BURN TO THE FUNDUS OF THE PATIENT'S UTERUS. THE INSTRUMENTS WERE REMOVED AND THEN RE-INSERTED INTO THE PATIENT AND THE SURGEON PROCEEDED WITH THE PROCEDURE. THE SURGICAL STAFF DID NOT EXPERIENCE ANY OTHER ISSUES WITH UNCOMMANDED CAUTERY ACTIVATION AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE OUTCOME.

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, LYSIS OF ADHESIONS AND BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2012 FOR ENDOMETRIAL CARCINOMA AND SIGNIFICANT PELVIC ADHESIVE DISEASE. 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 DA VINCI OPERATIVE REPORT, NO COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 50 ML. POST-OPERATIVELY, THE PATIENT EXPERIENCED ANEMIA AND ACUTE RENAL FAILURE. SHE RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS, AND HER ANEMIA SUBSEQUENTLY RESOLVED AND HER CREATININE IMPROVED. THERE WAS ALSO CONCERN FOR CONGESTIVE HEART FAILURE, ALTHOUGH AN ECHOCARDIOGRAM REVEALED A NORMAL EJECTION FRACTION. THE PATIENT WAS CONTINUED ON MODERATE FLUIDS AND WAS GIVEN A DOSE OF LASIX; AFTER THIS, HER SYMPTOMS IMPROVED AND HER EDEMA BEGAN TO IMPROVE. DUE TO LOW PLATELETS OF 59,000, THE PATIENT WAS GIVEN ONE DOSE OF DESMOPRESSIN ACETATE (DDAVP). THE PATIENT WAS AL

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) 2012 FOR SYMPTOMATIC UTERINE FIBROIDS AND PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION, ALTHOUGH IT WAS DIFFICULT TO SEE THE EXTENT OF THE BLADDER DUE TO THE SIZE OF THE UTERINE FIBROID AND ITS DISTORTION OF THE RELEVANT ANATOMY. THE SURGEON ATTEMPTED TO CREATE A BLADDER FLAP AND PUSH THE PERITONEUM AWAY. CAUTERIZATION OF THE UTERINE ARTERIES WAS PERFORMED AND BLANCHING WAS NOTED ON THE UTERUS. THE OPERATIVE REPORT STATED THAT THE URETERS WERE VISUALIZED THROUGHOUT. DUE TO AMBIGUITY IN THE LOCATION OF THE BLADDER, IT WAS FILLED WITH METHYLENE BLUE TO DIFFERENTIATE IT FROM NORMAL PERITONEUM. THE URETERS WERE NOTED TO BE FUNCTIONING AFTER REMOVAL OF THE UTERUS AND CERVIX. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT PRESENTED WITH LEFT SIDE AND LEFT ABDOMINAL PAIN IN ADDITION TO A LOW-GRADE FEVER. SHE WAS HOSPITA

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) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE INJURIES INCLUDING A TRANSECTED URETER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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)(4) ROBOTIC SURGERY PERFORMED BY DR (B)(6). A HYSTERECTOMY. I ENDED UP GOING TO 4 GYNECOLOGISTS TRYING TO FIGURE OUT WHAT HAPPENED TO ME. I BECAME VERY ILL WITH IMMUNE PROBLEMS, LOST MY JOB, NO SEX, AND NUMEROUS OTHER ISSUES.

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 A FEW DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED 'MINOR BLEEDING', THE BLEEDING WAS CONTROLLED IN THE OPERATING ROOM AND THERE WERE NO FURTHER COMPLICATIONS ASSOCIATED WITH THIS PATIENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE SITE.

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 UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: UNKNOWN IF RELATED TO SURGERY. SMALL BOWEL OBSTRUCTION STATUS POST GASTRIC BYPASS.

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 A FEW DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED 'MINOR BLEEDING', THE BLEEDING WAS CONTROLLED IN THE OPERATING ROOM AND THERE WERE NO FURTHER COMPLICATIONS ASSOCIATED WITH THIS PATIENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE SITE.

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 A FEW DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED 'MINOR BLEEDING', THE BLEEDING WAS CONTROLLED IN THE OPERATING ROOM AND THERE WERE NO FURTHER COMPLICATIONS ASSOCIATED WITH THIS PATIENT. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE SITE.

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 RADICAL PROSTATECTOMY PROCEDURE AND ANTERIOR URETHROPEXY PROCEDURE ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS PROSTATE CANCER. ACCORDING TO MEDICAL RECORDS PROVIDED, THE SURGEON DISCUSSED THE PROCEDURE AND RISKS WITH THE PATIENT AT A PRE-OPERATIVE VISIT. THE PATIENT WAS REPORTED TO UNDERSTAND THE RISKS, AND DESIRED THE ROBOTIC RADICAL PROSTATECTOMY SURGERY. BASED ON THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY 1 AFTER HE WAS ABLE TO TOLERATE A REGULAR DIET, HIS URINE WAS CLEAR, HIS DRAIN WAS REMOVED, AND HIS LAB TESTS WERE NOTED TO BE GOOD. THE PATIENT WAS DISCHARGED ON ORAL ANTIBIOTICS AND PAIN MEDICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE 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: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION,INCLUDING MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC SUPRA-CERVICAL HYSTERECTOMY ON (B)(6) 2012. DURING THE PROCEDURE,THE OPERATIVE REPORT NOTED THAT SOME SMALLER BRANCHES OF THE UTERINE ARTERIES WERE BLEEDING AND THESE WERE COAGULATED. IT WAS ALSO REPORTED THAT THE CERVICAL STUMP WAS OOZING AND A V-LOC RUNNING SUTURE WAS USED TO OBTAIN HEMOSTASIS. THERE WAS A SMALL AMOUNT OF OOZING NOTED IN THE MIDLINE REGION OF THE BLADDER AND FLOSEAL WAS PLACED IN THE AREA. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED HOME AS OUTPATIENT. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH COMPLAINTS OF ABDOMINAL PAIN. CT SCAN SHOWED FREE-FLUID NEAR BLADDER. PATIENT UNDERWENT CYSTOSCOPY, DIAGNOSTIC LAPAROSCOPY AND EXPLORATORY LAPAROTOMY ON (B)(6) 2012 WHICH FOUND A CYSTOTOMY, WHICH WAS REPAIRED. PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED ON (B)(6) 2012. PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 WITH GROSS HEMATURIA. PER MEDICAL RECORDS, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR CYSTOSCOPY AND CLOT EV

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 OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY AND BILATERAL SALPINGECTOMY PROCEDURE ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF ABNORMAL UTERINE BLEEDING AND PELVIC PAIN. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE INFORMATION PROVIDED IN THE OP REPORT ON (B)(6) 2012, AFTER THE PATIENT'S VAGINAL CUFF WAS CLOSED, GOOD HEMOSTASIS WAS NOTED. A CYSTOSCOPY WAS ALSO PERFORMED SHOWED THE PATIENT'S BLADDER WAS INTACT. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. REPORTEDLY, DURING A ROUTINE POST-OPERATIVE CHECKUP ON (B)(6) 2013, THE PATIENT COMPLAINED OF EXPERIENCING ABDOMINAL PAIN AND PAIN AROUND HER UMBILICUS. THE PATIENT ALSO COMPLAINED OF RECTAL BLEEDING. SHE WAS SUGGESTED TO STOP HER ESTROGEN AND START DEPO PROVERA. ON (B)(6) 2013, THE PATIENT RETURNED TO HER PH

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 ROBOTIC ADRENALECTOMY PROCEDURE FOR A VERY LARGE ADRENAL MASS ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP HOSPITAL RECORDS AND DEATH SUMMARY. 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) 2012 PATIENT UNDERWENT ROBOTIC ADRENALECTOMY. THE ADRENAL GLAND WAS NEARLY DETACHED WHEN AN EXCESSIVE AMOUNT OF BLEEDING WAS NOTED TO BE COMING FROM THE INFERIOR VENA CAVA. THEORETICALLY THE ADRENAL VEIN RUPTURED OR WAS TORN FROM THE IVC. EXCESSIVE BLEEDING ENSUED BUT WAS ULTIMATELY CONTROLLED BY PLACING A HAND PORT. A VASCULAR SURGEON WAS SUMMONED AND ARRIVED. AN IVC REPAIR WAS UNDERTAKEN AND ACCOMPLISHED VIA LAPAROTOMY. INTRAOPERATIVELY THE PATIENT BECAME HYPOTENSIVE AND SUFFERED CONSEQUENCES DESPITE RECEIVING A BLOOD TRANSFUSION. A MYOCARDIAL INFARCTION OCCURRED FOLLOWED BY A SEVERE ARRHYTHMIA. ON (B)(6) 2012, A CARDIAC CATHETERIZATION WAS PERFORMED WHICH SHOWED COMPLETE OCCLU

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) 2012, INTUITIVE SURGICAL RECEIVED INFORMATION FROM DR (B)(6), THE (B)(6) AT (B)(6) HOSPITAL, CONCERNING A POSTING ON AN ONLINE UROLOGY FORUM CALLED (B)(4) REGARDING AN ODD GERM. THE POSTING WAS DATED (B)(6) 2012 AND THE AUTHOR WAS DR. (B)(6). DR. (B)(6) INDICATED THAT A PATIENT, (B)(6) UNDERWENT A RADICAL PROSTATECTOMY PROCEDURE USING THE DA VINCI SURGICAL SYSTEM. DR. (B)(6) INDICATED THAT THE PATIENT WAS HOSPITALIZED FOR 8 DAYS AND THERE WAS AN ABSENCE OF ANY PATHOLOGICAL FINDINGS AFTER THE SURGERY PROCEDURE. DR. (B)(6) INDICATED THAT THE PATIENT'S HISTOLOGY WAS PT2 N0 GL 7APSA 5.7 NG. DR. (B)(6) INDICATED IN THE POSTING AFTER 11 WEEKS CLINICAL INFECTION, BACTEREMIA WITH BACTEROIDES FRAGILIS IN THE BLOOD CULTURE (FACULTATIVE PATHOGENIC BACTERIA). CAUSE WAS AN INFECTED LYMPHOCELE, IN THE PUNCTUATION ALSO BACTEROIDES FR. DR. (B)(6) ALSO INDICATED IN THE POSTING THEREFORE AN UNUSUAL GERM, PROMINENT PROTRACTED DEVELOPMENT. ISOLATED CASE? CONNECTION WITH METHOD? NO OTHER INFORMATION CONCERNING THE REPORTED INCIDENT 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 2 DAYS POST A SUCCESSFUL DA VINCI SI MYOMECTOMY PROCEDURE, THE PATIENT EXPIRED. THE INTUITIVE SURGICAL CLINICAL SALES REPRESENTATIVE (CSR) THAT REPORTED THIS INCIDENT INDICATED THAT ON (B)(6) 2012, THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE REPORTED TO HIM THAT A TENACULUM FORCEPS INSTRUMENT BEING USED DURING THE SURGICAL PROCEDURE WAS NOT MOVING AS IT SHOULD. THE CSR INDICATED THAT HE INSTRUCTED THE SURGEON TO HAVE THE INSTRUMENT REMOVED, CLEANED AND RE-INSTALLED. THE CSR INDICATED THAT THE SITE PROCEEDED USING THE INSTRUMENT AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED TO HAVE OCCURRED AT THE TIME OF THE SURGICAL PROCEDURE. ON (B)(6) 2012, THE INTUITIVE SURGICAL CSR WAS NOTIFIED BY THE SURGEON THAT THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL ON (B)(6) 2012 DUE TO A PERFORATED BOWEL AND THE PATIENT EXPIRED ON (B)(6) 2012. THE CSR INDICATED THAT THE SURGEON INDICATED THE SURGICAL PROCEDURE WENT FINE. THE SURGEON INDICATED TO THE CSR THAT A VIDEO RECORDING OF THE SURGICAL PROCEDURE IS NOT AVAILABLE AND THAT THE CAUSE OF THE PATIENT'S INJURY IS UNKNOWN. LATE SUBMISSION OF THE MEDWATCH REPORT IS DUE TO

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 A PATIENT SUSTAINED A BILE DUCT INJURY DURING A DA VINCI SI SINGLE SITE BILE DUCT PROCEDURE. THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE TO HAVE THE DAMAGED BILE DUCT REPAIRED AT (B)(6) IN (B)(6). NO OTHER INFORMATION CONCERNING THE PATIENT AND EVENT DETAILS WERE PROVIDED BY THE INITIAL REPORTER.

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) 2012. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT'S URETER, VAGINA, AND OTHER ORGANS NOT ASSOCIATED WITH THE PROCEDURE WERE NEGLIGENTLY INJURED DURING THE DA VINCI HYSTERECTOMY PROCEDURE AND HER INJURIES RESULTED IN THE NECESSITY OF CONTINUED FOLLOW-UP CARE, SURGICAL INTERVENTION, CONTINUING INFECTIONS, AND EMBARRASSING SIDE EFFECTS. THE LEGAL DOCUMENT DOES NOT PROVIDE THE SITE NAME, SURGEON NAME, DA VINCI SYSTEM SERIAL , OR ANY OTHER SPECIFIC DETAILS ABOUT THE PATIENT'S DA VINCI HYSTERECTOMY PROCEDURE. THERE WAS NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY.

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) 2012, AN ARTICLE TITLED POSTERIOR ISCHEMIC OPTIC NEUROPATHY AFTER MINIMALLY INVASIVE PROSTATECTOMY PUBLISHED IN J NEURO-OPHTHALMOL, VOL 27, NO 4, 2007 WAS REVIEWED BY AN ISI CLINICAL PROJECT MANAGER. PER THE INFORMATION IN THE ARTICLE, POST OP A DA VINCI PROSTATECTOMY PROCEDURE THE PATIENT COMPLAINED OF PURPLE VISION AND LOSS OF INFERIOR VISUAL FIELDS IN BOTH EYES. THE ARTICLE INDICATES THAT THE PATIENT'S SYMPTOMS WORSENED WHEN HE WAS UPRIGHT AND ON THE SAME DAY A NEURO-OPHTHALMOLOGIST RECORDED VISUAL ACUITIES OF 20/25 IN BOTH OF THE PATIENT'S EYES. THE ARTICLE INDICATES THAT THE PATIENT DID NOT HAVE FACIAL EDEMA AND THE OPTIC DISCS WERE DESCRIBED AS OF NORMAL APPEARANCE WITH A CUP/DISC RATIO OF 0.25. THE ARTICLE ALSO INDICATED THAT AUTOMATED HUMPHREY VISUAL FIELDS DEMONSTRATED BILATERAL INFERIOR ALTITUDINAL DEFECTS AND THE PATIENT'S HEMOGLOBIN LEVEL WAS 9.7 G/DL. THE ARTICLE INDICATES THAT THE PATIENT'S BLOOD PRESSURE AND PULSE WERE NORMAL. THE ARTICLE INDICATES THAT THE RESULTS OF PREOPERATIVE LABORATORY STUDIES PERFORMED 1 WEEK BEFORE THE PROCEDURE WERE ALL WITHIN NORMAL RANGES, WITH HEMOGLOBIN OF 14.2 G/DL AND THAT THE PATIENT'S BLOOD PRESSURE ON THE MORNING OF THE SU

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) 2012 FOR CERVICAL DYSPLASIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES THE FOLLOW UP RADIOLOGY AND OPERATIVE REPORTS AND OFFICE NOTES. 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) 2012, THE PATIENT PRESENTED WITH A 1 MONTH HISTORY OF URINARY LEAKAGE AND A RECENT CYSTOSCOPY AND RETROGRADE PYELOGRAM SHOWED LEFT URETERAL BLOCKAGE. THERE WAS UNSUCCESSFUL CROSSING INTO THE BLADDER. A LEFT NEPHROSTOMY TUBE PLACED. A LEFT URETERAL INJURY WAS FOUND AT THE URETEROVESICAL JUNCTION. AN URETERAL RE-IMPLANTATION IS IN THE PLANNING STAGES.

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 AFTER A SUCCESSFUL DAVINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD SUSTAINED A BURN TO THE UPPER LIP. THE SURGEON, DR (B)(6), INDICATED THAT NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO TREAT THE PATIENT; HOWEVER, OINTMENT WAS APPLIED TREAT THE AFFECTED AREA. DR (B)(6) INDICATED THAT THE PATIENT HAS NOT RETURNED TO THE SITE AS A RESULT OF THE REPORTED EVENT. DR (B)(6) ALSO INDICATED THAT HE DOES NOT RECALL OF TRADITIONAL LAPAROSCOPIC TECHNIQUES WERE USED DURING THE SURGICAL PROCEDURE. DR (B)(6) ALSO INDICATED THAT AN 8MM CANNULA WAS USED IN CONJUNCTION WITH THE 5MM INSTRUMENTS, AND IT IS HIS BELIEF THAT THE BURN SUSTAINED THE PATIENT WAS CAUSED BY THE CANNULA. DR (B)(6) INDICATED THAT THE 5MM FLARED CANNULA IS NOW BEING USED FOR TORS PROCEDURES AT (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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL BENIGN HYSTERECTOMY PROCEDURE ON (B)(6) 2012. 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: ON (B)(6) 2013, INTUITIVE SURGICAL (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SIGMOID COLECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED: IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT SUFFERED SEVERE COMPLICATIONS, INCLUDING, BUT NOT LIMITED TO, AN ANASTOMOSIS LEAK REQUIRING A SECOND OPERATION. IN ADDITION THE LEGAL COMPLAINT STATES THAT THE SURGICAL EQUIPMENT MANUFACTURED BY ISI MALFUNCTIONED, CAUSING AND RESULTING IN SEVERE INJURIES AND THAT THE PATIENT WAS HURT AND INJURED IN HIS HEALTH, STRENGTH AND ACTIVITY, SUSTAINING INJURY TO HIS BODY AND PERSON THIS WAS REPORTED TO HAVE CAUSED THE PATIENT GREAT MENTAL, PHYSICAL, AND NERVOUS PAIN AND SUFFERING.

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 (B)(6) 2012. THE PATIENT REPORTEDLY SUSTAINED A PERFORATED BLADDER FOLLOWING THE HYSTERECTOMY PROCEDURE. NO SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. NO OTHER DETAILS WERE 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: IT WAS REPORTED THAT AFTER OF A SUCCESSFUL DAVINCI S HYSTERECTOMY W/SACROCOLPOPEX PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE TROCARS FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED SUPERFICIAL BURNS AT THE PORT SITE INCISIONS. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURE OR TREATMENT FOR THE BURNS. NO ADDITIONAL PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND BILATERAL PERIAORTIC AND PELVIC LYMPH NODE DISSECTION PROCEDURE FOR CERVICAL CANCER ON (B)(6) 2012. REPORTEDLY, THE PATIENT SUSTAINED A URETERAL INJURY REQUIRING THE PATIENT TO UNDERGO A STENT IMPLANTATION AND REMOVAL, A CYSTOGRAM AND A CYSTOSCOPY. ON (B)(6) 2013, THE PATIENT EXPIRED DUE TO METASTATIC CERVICAL CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT AND FOLLOW-UP HOSPITAL MEDICAL RECORDS. A CAREFUL REVIEW OF THE MEDICAL DOCUMENTATION WAS CONDUCTED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS, AND/OR ACCESSORIES DURING THE DA VINCI SURGICAL PROCEDURE AND THERE WAS NO INDICATION THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. ACCORDING TO THE INFORMATION IN THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2013, THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO FALLING AT HOME. DURING THE PATIENT'S HOSPITALIZATION THE PATIENT WAS FOUND TO BE ANEMIC, DEHYDRATED AND HAD WORSENING SYMPTOMS OF PARKINSON'S DISEASE. THE PATIENT WAS DIAGNOSED WITH ACUTE REN

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 PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PIECE OF UTERUS FELL DOWN AND BURNED A HOLE IN BLADDER.

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) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL DEMAND INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, EXPERIENCED POST-SURGICAL COMPLICATIONS, REQUIRING THE PATIENT TO UNDERGO SUBSEQUENT TREATMENT. THE PATIENT'S OPERATIVE REPORTS AND OTHER RELATED MEDICAL RECORDS WERE ALSO PROVIDED TO ISI. THE PATIENT'S MEDICAL RECORDS INDICATED THE FOLLOWING: THE PATIENT'S MEDICAL HISTORY AS INDICATED IN THE OPERATIVE REPORT REGARDING THE DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE INDICATED THAT THE PATIENT EXPERIENCED CONTINUED AND WORSENING PAIN WITH HER MENSTRUAL CYCLE. THE OPERATIVE REPORT DID NOT INDICATE THAT ANY INTRA-OPERATIVE COMPLICATIONS WERE EXPERIENCED BY THE PATIENT. THE PATIENT'S UTERUS WAS REMOVED VAGINALLY AND EXCELLENT HEMOSTASIS WAS NOTED. THE PATIENT'S ABDOMINAL CAVITY WAS IRRIGATED, INSPECTED AND THERE WAS NO BLEEDING FROM ANY SITES. THERE WAS NO INDICATION IN THE PATIENT'S OPERATIVE REPORT THAT ANY MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013 THE PATIENT UNDERWENT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: HARMONIC ACE SHEARS INSERT TIP BROKE OFF INSIDE THE PT DURING SURGICAL INTERVENTION. REASON FOR USE: ROBOTIC MYOMECTOMY TUBAL PERFUSION DX LAPAROSCOPY.

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 DISCOVERY ACTIVITY, ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT DURING THE SURGICAL PROCEDURE, AN UNPLANNED SMALL INCISION WAS MADE INTO THE PATIENT'S BLADDER. THE DEFECT TO THE PATIENT'S BLADDER WAS REPAIRED BY THE HOSPITAL'S UROLOGIST. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE SUSTAINED A THERMAL BOWEL INJURY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

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 AND ADHESIOLYSIS FOR PELVIC PAIN, OVARIAN CYST, AND MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (B)(6) 2012. 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 TRANSVAGINAL PLACEMENT OF THE RUMI AND CREATION OF A PNEUMOPERITONEUM WITH A TRANSUMBILICALLY INSERTED VERESS NEEDLE, 5 PORTS WERE INSERTED INTO THE ABDOMEN (FOUR UNDER DIRECT VISUALIZATION) AND THE ROBOT WAS DOCKED. ON INITIAL INSPECTION, ADHESIONS OF THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL WERE FOUND, WHICH WERE TAKEN DOWN WITH SHARP DISSECTION, AS WELL AS ELECTROCAUTERY. THE INSPECTION REVEALED GOOD URETERS. BILATERAL LATERAL LIGAMENTS FROM THE UTERUS TO THE PELVIS WERE BURNED WITH THE PK AND CUT; THE BLADDER FLAP COMPLETED AND DISSECTED OF THE UTERUS, THE UTERINE VESSELS CLAMPED AND BURNED AND THEN AN ANTERIOR 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: ON (B)(4) 2013, ISI RECEIVED A LEGAL COMPLAINT ALLEGING THAT A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, AT (B)(6), EXPERIENCED POST-OPERATIVE COMPLICATIONS OF BILATERAL RENAL OBSTRUCTION AND ACUTE RENAL FAILURE.

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 TWO DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED DUE TO UNCONTROLLABLE POST OPERATIVE BLEEDING.

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 HYSTERECTOMY WITH CYSTOSCOPY PROCEDURE ON (B)(6) 2012. 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. ON (B)(6) 2012, THE PATIENT PRESENTED WITH VAGINAL BLEEDING. THE PATIENT WAS FOUND TO HAVE A SMALL SEPARATION OF THE VAGINAL CUFF WITH AN AREA OF VENOUS BLEEDING. SUTURES WERE PLACED TO STOP THE BLEEDING AND CLOSE THE VAGINAL DEFECT. NO FURTHER CLINICAL 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: IT WAS REPORTED THAT 4 DAYS AFTER A DA VINCI SI HYSTERECTOMY SURGERY THE PATIENT PRESENTED A DISTENDED ABDOMEN AND COMPLAINED OF PAIN. IMAGING WAS PERFORMED AND THE SURGICAL STAFF CONCLUDED THE PATIENT HAD A SBO (SMALL BOWEL OBSTRUCTION) AND A PORT SITE HERNIA. THE PATIENT HAD A LAPAROTOMY AND SMALL BOWEL RESECTION 1 WEEK AFTER THE ORIGINAL SURGERY AND WAS IN THE HOSPITAL 2-3 WEEKS AFTER THAT. ON (B)(6) 2012 THE SURGEON CONFIRMED THAT PATIENT IS AT HOME AND DOING WELL CURRENTLY. THIS INVESTIGATION IS STILL ONGOING AND A FOLLOW-UP MDR WILL BE GENERATED IF ADDITIONAL INFORMATION IS RECEIVED.

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)(6) 2013, INTUITIVE SURGICAL, INC.(ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2012 DUE TO A RIGHT RENAL MASS AND A POSSIBLE CYSTIC RENAL CELL. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THE PROCEDURE WAS COMPLEX, AND TOOK MULTIPLE HOURS TO PERFORM. AN INTRA-OPERATIVE ULTRASOUND WAS PERFORMED AND CONFIRMED THAT THE MASS WAS LOCATED DEEP INSIDE OF THE KIDNEY, WHICH REQUIRED EXTENSIVE RECONSTRUCTIVE EFFORTS. ACCORDING TO THE OP REPORT, THERE WAS NO REPORTED MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. NO INTRA-OPERATIVE ADVERSE EVENT WAS REPORTED EITHER. THE PATIENT WAS RE-ADMITTED DUE TO LIVER LACERATION. THE MEDICAL CHARTS FOR THIS HOSPITALIZATION WERE NOT AVAILABLE, BUT IN THE DOCUMENTATION DATED (B)(6) 2012, THIS RE-ADMISSION WAS STATED. ON (B)(6), 2012 VISIT, THE PATIENT WAS REPORTEDLY IMPROVING. ON (B)(6) 2012, THE PATIENT VISITED THE DOCTOR'S OFFICE AND HE CONTINUED TO IMPROVE. THE PATIENT APPEARED WELL WITH NO OBVIOUS SIGNS OF DISTRESS. NO MEDICAL RECORDS SINCE THIS OFFICE VISIT WERE 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 WHO UNDERWENT A DA VINCI HYSTERECTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT DURING THE SURGICAL PROCEDURE HER URETER, VAGINA BLADDER, AND OTHER ORGANS NOT ASSOCIATED WITH THE PROCEDURE WERE NEGLIGENTLY INJURED, AND THESE INJURIES RESULTED IN THE NECESSITY OF CONTINUED FOLLOW-UP CARE, SURGICAL INTERVENTION, AND EMBARRASSING SIDE-EFFECTS. IN ADDITION, THE LEGAL DOCUMENT CLAIMS THAT THE PATIENT HAS UNDERGONE SEVERE PHYSICAL PAIN AND MENTAL ANGUISH, SUFFERED PERMANENT DEBILITATING INJURIES, INCURRED SUBSTANTIAL HOSPITAL AND MEDICAL BILLS AND RELATED COSTS, LOST WAGES, AND WILL CONTINUE TO SUFFER SUCH DAMAGES IN THE FUTURE.

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) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT INDICATING THAT A PATIENT WHO UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2012, SUSTAINED AN INTRA-OPERATIVE THERMAL BURN TO THE BLADDER, RESULTING IN A LACERATION THAT REQUIRED THE PLACEMENT OF A FOLEY CATHETER AND FURTHER HOSPITALIZATION. THE LEGAL COMPLAINT ALSO ALLEGES THAT THE PATIENT REQUIRED AN INTRA-OPERATIVE PLACEMENT OF A TRANSOBTURATOR TAPE (BLADDER SLING) WHICH CAUSED EROSION OF THE PATIENT'S VAGINAL MESH, REQUIRING THE PATIENT TO UNDERGO TWO SUBSEQUENT SURGICAL PROCEDURES. PER THE INFORMATION INDICATED IN THE LEGAL COMPLAINT, THE PATIENT CONTINUES TO SUFFER FROM CHRONIC VAGINAL PAIN AND INCONTINENCE, THUS REQUIRING THE PATIENT TO WEAR BLADDER PADS. THE PATIENT ALSO REQUIRES FURTHER BLADDER RECONSTRUCTIVE SURGERY AND URETERAL RE-IMPLANTATION. REPORTEDLY DUE TO THE INJURY SUSTAINED BY THE PATIENT DURING THE SURGICAL PROCEDURE, THE PATIENT HAS UNDERGONE AND CONTINUES TO UNDERGO MULTIPLE PAINFUL ADDITIONAL MEDICAL TESTS AND PROCEDURES, PHYSICIAN CONSULTATIONS AND ADDITIONAL SURGERIES. THE PATIENT HAS SUFFERED AND CONTINUES TO SUFFER PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS AND PERMANENT INJUR

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) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: URETER WAS DAMAGED.

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) 2012, AND ALLEGED TO HAVE SUSTAINED A RIGHT URETER INJURY THAT REQUIRED A SURGERY TO CORRECT.

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)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR UTERINE FIBROIDS, MENORRHAGIA AND ANEMIA. ONE WEEK PRIOR TO THE DA VINCI SURGICAL PROCEDURE ((B)(6) 2012), THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WITH COMPLAINTS OF GENERALIZED WEAKNESS, DIZZINESS, AND NAUSEA. FOR ONE WEEK PRIOR TO THE ER VISIT, SHE HAD HEAVY PERIOD AND PASSED SOME CLOTS. THE PATIENT'S POTASSIUM AND HEMOGLOBIN LEVELS WERE LOW. SHE RECEIVED A BLOOD TRANSFUSION AND HER REPEAT HEMOGLOBIN WAS 12 AND HER POTASSIUM WAS NORMAL. SHE WAS DIAGNOSED WITH ACUTE BLOOD LOSS ANEMIA, SYMPTOMATIC SECONDARY TO MENORRHAGIA AND HYPOKALEMIA. THE PATIENT'S CONDITION WAS OVERALL STABLE AND WAS SENT HOME THE SAME DAY. ON (B)(6) 2012, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD A MARKEDLY LARGE UTERUS (16-WEEK UTERUS WITH MULTIPLE UTERINE FIBROIDS) ALONG WITH DENSE PELVIC ADHESIONS FROM THE OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THE ADHESIONS WERE LYSED WITH MONOPOLAR SCISSORS AND PK INSTRUMENT WITHOUT

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6), THE PATIENT EXPIRED. THE DATE OF THE PATIENT'S DEATH AND CAUSE OF DEATH ARE UNKNOWN.

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 HYSTERECTOMY FOR UTERINE FIBROIDS, MENORRHAGIA, AND ENDOMETRIAL HYPERPLASIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. SUBSEQUENT OPERATIVE REPORTS AND EVALUATIONS WERE INCLUDED 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 AN UNUSUALLY DIFFICULT PROCEDURE; HOWEVER, DUE TO EXTREME OBESITY AND BMI OR(B)(6). THE OPERATION TOOK 5 HOURS AND THE UTERUS WEIGHTED OVER 500 GRAMS. ON THE DAY OF HER DISCHARGE SHE WAS FOUND TO HAVE PRE-RENAL AZOTEMIA WITH A RAPIDLY RISING CREATININE. SHE WAS TREATED MEDICALLY AND HER ACUTE RENAL FAILURE RESOLVED. ON (B)(6) 2012, THE PATIENT PRESENTED WITH COMPLAINTS OF LEAKING FLUID PER VAGINA AND UNDERWENT CYSTOSCOPY AND PLACEMENT OF A STENT. A LACERATION WAS SEEN IN THE URETER ALONG WITH A SMALL PIECE OF SUTURE NEAR THE LUMEN OF THE URETER. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THIS DATE.

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 ROBOT ASSISTED MITRAL VALVE REPAIR AND CRYO MAZE PROCEDURE ON (B)(6) 2012 FOR MODERATE TO SEVERE MITRAL REGURGITATION AND ATRIAL FIBRILLATION. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT, PREOPERATIVE HISTORY AND PHYSICAL, AND DISCHARGE SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THERE WERE NO INTRAOPERATIVE COMPLICATIONS DURING THE PERFORMANCE OF THE MITRAL VALVE SURGERY. THE ROBOTIC ASSISTED MITRAL VALVE REPAIR WAS PERFORMED FIRST AFTER PLACING THE PERSON ON CARDIOPULMONARY BYPASS UTILIZING THE RIGHT FEMORAL ARTERY AND IVC CANNULA. SYSTEMIC COOLING WAS DONE PRIOR TO AORTIC CROSS CLAMP AND THE HEART WAS NEXT PERFUSED WITH CARDIOPLEGIA. SYSTEMIC HYPERTHERMIA TO 32 DEGREES C WAS UTILIZED AS WAS REPEAT INFUSIONS OF CARDIOPLEGIA. THE ROBOTIC APPROACH WAS DONE THOUGH THE INTER-ATRIAL EXPOSURE. THE VALVE WAS REPAIRED USING AN ANNULOPLASTY RING. THE ATRIA WAS THEN CLOSED. AFTER COMPLETION OF THE MITRAL VALVE REPAIR WITH THE ROBOT THE CYROMAZE PROCEDURE 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND LEFT SALPINGO-OOPHORECTOMY PROCEDURE WITH EXTENSIVE LYSIS OF ADHESIONS ON (B)(6) 2012. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS WAS MENORRHAGIA, UTERINE FIBROIDS, AND HISTORY OF MODERATE CERVICAL DYSPLASIA. ACCORDING TO THE MEDICAL RECORDS PROVIDED, INFORMED CONSENT WAS OBTAINED FROM THE PATIENT PRIOR TO THE DA VINCI SI SURGICAL PROCEDURE. BASED ON THE OPERATIVE REPORT, THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED WITH NO REPORTED INTRA-OPERATIVE COMPLICATIONS. HOWEVER, DURING THE SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SEVERE PELVIC ADHESIVE DISEASE AND ABDOMINAL ADHESIVE DISEASE WITH FINDINGS OF OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL LINING, THE RIGHT SIDE OF THE PELVIS AND ABDOMINAL WALL, AS WELL AS THE PELVIC SIDEWALLS. THE PATIENT'S LEFT TUBE AND OVARY WERE ALSO FOUND TO BE SEVERELY ADHERED TO THE LEFT PELVIC SIDEWALL. AFTER COMPLETION OF THE SURGICAL PROCEDURE, THE PATIENT WAS EXTUBATED AND TAKEN TO THE RECOVERY ROOM AWAKE, ALERT, AND IN STABLE CONDITION. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN