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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF A SYMPTOMATIC FIBROID UTERUS, WITH A LARGE FIBROID ON THE RIGHT SIDE OF THE UTERUS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT DURING DETACHMENT OF THE FIBROID FROM THE RIGHT SIDE OF THE PATIENT'S PELVIC SIDEWALL, BLEEDING WAS NOTED COMING FROM A FEEDING VESSEL OF THE FIBROID. HEMOSTASIS WAS ACHIEVED WITH CLIP PLACEMENT. FIBRILLAR WAS ALSO PLACED FOR HEMOSTASIS. THE OPERATIVE REPORT DESCRIBES THE USE OF A LAPAROSCOPIC CAMERA, AND AN ENDOSCOPE MORCELLATOR THROUGH A 12 MM PORT. AFTER THE PATIENT'S UTERUS WAS REMOVED AND THE SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH URINARY RETENTION. PER OPERATIVE REPORTS, A CT SCAN WAS PERFORMED WHICH SHOWED A PELVIC ABSCESS AND PARTIAL COMPRESSION OF THE RIGHT URETER. ON (B)(6) 2011, THE PATIENT UNDERWENT BILATERAL URETE

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 ADDITIONAL INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THE PATIENT SUSTAINED POST OPERATIVE INJURIES, INCLUDING RUPTURE OF THE BLADDER, CREATION OF FISTULA, AND OTHER PHYSICAL AND PSYCHOLOGICAL SEQUELAE AS SET FORTH IN THE MEDICAL RECORD. SPECIFIC DETAILS OF THE DA VINCI SURGERY WERE NOT PROVIDED AND THE LEGAL DOCUMENT DOES NOT ANY SPECIFIC ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY THAT OCCURRED DURING THE REPORTED SURGICAL PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI S OVARIAN CYSTECTOMY PROCEDURE, THE SURGEON ENCOUNTERED EXCESSIVE ADHESIONS WITHIN THE PATIENT'S ANATOMY WHICH MADE IT DIFFICULT TO PERFORM THE PROCEDURE LAPAROSCOPICALLY. AT THIS TIME, THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN TECHNIQUES TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ISSUES NOTED. APPROXIMATELY TWO TO THREE WEEKS POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH ILEUS. IT IS UNKNOWN HOW THE PATIENT WAS TREATED; HOWEVER, THE PATIENT EXPIRED AFTER BEING DIAGNOSED. THE SITE'S RISK MANAGEMENT DEPARTMENT HAS BEEN CONTACTED SEVERAL TIMES TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, OUR ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE DELAY IN REPORTING IS DUE TO AN ISI EMPLOYEE'S MISUNDERSTANDING OF COMPLAINT REPORTING CRITERIA. THE SITE ADVISED THAT THERE WAS NOT CORRELATION BETWEEN OUR SYSTEM AND THE EVENT AND OUR ISI REPRESENTATIVE UNDERSTOOD THE SITE'S FEEDBACK AS NOT REQUIRING THE INITIATION OF A COMPLAINT RECORD. SINCE THIS MISUNDERSTANDING WAS DISCOVERED, RETRAINING HAS BEEN PERFORMED WITH THE ISI REPRESENTATIVE TO MITIGATE FUTURE OCCURRENCES.

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) 2011. 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 ROBOTIC LEFT OOPHORECTOMY , RIGHT OVARIAN CYST DRAINAGE, AND EXCISION OF RIGHT PARATUBAL CYST FOR CHRONIC PAIN ON (B)(6) 2011. 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) 2011, THE PATIENT PRESENTED WITH DA VINCI ROBOTIC LAPAROSCOPIC REMOVAL OF LEFT OVARY, LYSIS OF ADHESIONS AND RIGHT OVARIAN CYST DRAINAGE WITH ELECTROCAUTERY AND EXCISION OF RIGHT PARATUBAL CYST. ON (B)(6) 2011, READMITTED FOR ABDOMINAL PAIN. CT NOTED FREE AIR IN ABDOMEN BUT NO EVIDENCE OF BOWEL PERFORATION. WITH IV AND ANTIBIOTICS. REPEAT CT SHOWED IMPROVEMENT OF FREE AIR IN ABDOMEN. DISCHARGED HOME ON (B)(6) 2011. THE PATIENT WAS IN AND OUT OF THE HOSPITAL OVER 6 MONTH PERIOD WITH SYMPTOMS OF RECURRENT SMALL BOWEL OBSTRUCTIONS WHICH ALWAYS IMPROVED WITH HOSPITALIZATION, IV FLUIDS AND ANTIBIOTICS. HAS SYMPTOMS OF PAIN, VOMITING, DISTENTION. TAKING ANTI EMETICS. ON (B)(6) 2011 - ADMITTED AGAIN FOR CONTINUED BOWEL

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) 2011. 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 MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE. THE PATIENT HAD A LARGE UTERUS AND IT WAS NOTED DURING THE SURGICAL PROCEDURE THAT THE PATIENT HAD FIBROIDS. DURING THE PROCEDURE, THE SURGEON REPORTEDLY HAD TO ENTER THE PATIENT'S VAGINA IN TWO SPOTS DUE TO THE DISTORTION OF THE ANATOMY CAUSED BY THE FIBROIDS. THESE SPOTS WERE REPAIRED VAGINALLY WITHOUT CONSEQUENCE AT THE SURGERY. THERE WERE NO COMPLICATIONS NOTED AT THE TIME OF THE SURGERY. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY AND ON (B)(6) 2011, THE PATIENT EXPERIENCED PROBLEMS. A CT SCAN PERFORMED ON (B)(6) 2011 NOTED A POSSIBLE BLADDER INJURY. ON (B)(6) 2011, THE PATIENT UNDERWENT A SURGICAL VAGINAL REPAIR OF A VESICOVAGINAL FISTULA WITH LEFT URETERAL CATHETER PLACEMENT, ATTEMPTED RIGHT URETERAL CATHETER PLACEMENT, AND CYSTOSCOPY. IN (B)(6) 2011 THE PATIENT WAS RE-ADMITTED AND THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH ABDOMINOVESICAL FISTULA REPAIR ON (B)(6) 2011. THE PATIENT WAS DISCHARGED AFTER TWO DAYS.

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 PARAMETRECTOMY, UPPER VAGINECTOMY, BILATERAL PELVIC LYMPH NODE DISSECTION, BILATERAL COMPLETE URETEROLYSIS, AND LEFT URETERAL STENT PLACEMENT FOR UNEXPECTED DIAGNOSIS OF AN ENDOCERVICAL ADENOCARCINOMA AFTER HYSTERECTOMY AND RETROPERITONEAL FIBROSIS ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH OPERATIVE REPORTS (2X (B)(6) 2011). ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2011, DISCHARGE SUMMARY (B)(6) 2011, OUTSIDE SLIDE REPORT - (B)(6) 2011, ONCOLOGY CONSULTATION (B)(6) 2011 THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS REPORT OF AN INTRAOPERATIVE CYSTOTOMY DURING URETEROLYSIS OF THE LEFT URETER. THE OPERATION WAS INITIATED WITH BILATERAL PLACEMENT OF URETERAL CATHETERS, THEN AN EEA SIZER WAS PLACED IN THE VAGINA AND A PNEUMOPERITONEUM CREATED THROUGH A SUPRAUMBILICAL INCISION. ON INSPECTION THERE WAS EVIDENCE OF SIGNIFICANT RETROPERITONEAL FIBROSIS ON THE LEFT OF THE PELVIS. DENSE ADHESIONS OF HER RECTOSIGMOID COLON TO THE LEFT PELVIC SIDEWALL

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 AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2011 FOR SEVERE MENORRHAGIA WITH FIBROIDS. THE OPERATIVE REPORT FOR THE DA VINCI SI PROCEDURE WAS NOT PROVIDED; HOWEVER, MEDICAL RECORDS FROM FOLLOW UP VISITS INDICATE THAT THE PATIENT DID NOT SUSTAIN ANY APPARENT INTRAOPERATIVE INJURY. PATIENT WAS DISCHARGED THE NEXT DAY. ON (B)(6) 2011, THE PATIENT REPORTED INCREASING ABDOMINAL PAIN AND PRESENTED TO THE EMERGENCY ROOM. SHE UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND INTRA-ABDOMINAL WASHOUT FOR POST-OPERATIVE PERITONITIS WITH PELVIC HEMATOMA. LATER THE SAME MONTH, THE PATIENT RECEIVED A RIGHT URETERAL STENT FOR RIGHT URETEROVAGINAL FISTULA. IN (B)(6) 2011, A CYSTOSCOPY REVEALED THAT THE URETEROVAGINAL FISTULA HAS HEALED AND THE STENT WAS REMOVED. IN NOVEMBER 2012, THE PATIENT HAD COMPLAINTS OF POST COITAL BLEEDING WITH NO PAIN. IN (B)(6) 2012, THE PATIENT UNDERWENT A REVISION OF VAGINAL CUFF FOR A SMALL VAGINAL CUFF DEFECT. THE PATIENT'S CURRENT CONDITION WAS NOT 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, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY ON (B)(6) 2011 FOR PELVIC PAIN, MENORRHAGIA, AND FIBROID UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. PER THE OPERATIVE REPORT, THE UTERUS AND CERVIX REQUIRED MORCELLATION TO REMOVE DUE TO SIZE. THE VAGINAL CUFF WAS ALSO LEFT TO CLOSE ON ITS OWN, AS IT WAS NOTED TO BE VERY DEEP AND HIGH AND PROVED TO BE TECHNICALLY VERY DIFFICULT TO CLOSE. THE VAGINA WAS SUBSEQUENTLY PACKED WITH 1 INCH IODOFORM TAPE. NO OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS 150 ML. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. A DISCHARGE SUMMARY WAS NOT AVAILABLE FOR REVIEW. THE PATIENT PRESENTED TO HER DOCTOR THE DAY AFTER DISCHARGE FOR A MASS IN HER VAGINA. HER VAGINAL PACKING WAS REMOVED AND SHE WENT HOME. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE ER WITH COMPLAINTS OF SEVERE FLANK PAIN AND WAS ADMITTED WITH PRESUMED PYELONEPHRITIS. SHE WAS TREATED WITH ANTIBIOTICS, AND A CT IVP SHOWED NO INJURY TO THE RIGHT URETER AND INCOMPLETE VISUALIZATION OF THE LEFT URETER. PERSISTENT COPIOUS WATERY VAGI

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 HYSTERECTOMY FOR CHRONIC PAIN AND UTERINE LEIOMYOMATA ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP MEDICAL NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. HOWEVER, THERE WAS AN INADVERTENT CYSTOTOMY PERFORMED AT THE APEX OF THE BLADDER DUE TO EXTENSIVE INTRAABDOMINAL ADHESIONS AND A SMALL BOWEL HERNIA INVOLVING SMALL BOWEL, BLADDER AND THE ANTERIOR ABDOMINAL WALL PERITONEUM. THIS CYSTOTOMY WAS CLOSED PRIMARILY WITH A WATERTIGHT TWO-LAYERED CLOSURE. ON (B)(6) 2011, THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND WAS FELT TO HAVE A DRAINING HEMATOMA. THE SYMPTOMS RESOLVED.

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 PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION FOR PROSTATE CANCER ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE FOLLOW UP OPERATIONS, BUT NO MEDICAL HISTORY OR IMAGING REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PROSTATECTOMY WAS STARTED WITH EXPOSURE AND SHARP TRANSECTION OF THE BLADDER NECK, FOLLOWED BY DIVISION OF VAS DEFERENS, DISSECTION OF THE SEMINAL VESICLES, AND PROSTATIC PEDICLES. THE LEFT NEUROVASCULAR BUNDLE WAS CLIPPED SECONDARY TO HIGH VOLUME DISEASE ON THE LEFT. THE APEX WAS DISSECTED, DORSAL VENOUS COMPLEX CAUTERIZED AND DIVIDED AND THE URETHRA SHARPLY DIVIDED. IN ADDITION THERE WAS SIGNIFICANT BLEEDING FROM THE BLADDER NECK AND PROSTATIC PEDICLE ON THE LEFT WHICH WAS CONTROLLED WITH SEVERAL SUTURES. THERE WAS NO EVIDENCE OF RECTAL INJURY AT THE TIME PELVIC LYMPH NODES WERE THEN DISSECTED, CLIPPED AND REMOVED TO THE OBTURATOR NERVE. THE URETHRAL/BLADDER NECK ANASTOMOSIS WAS COMPLETED. AFTER COMPLETION

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: CAUTERY SPATULA USED DURING A LUNG PROCEDURE WAS MISSING PART OF THE PROTECTIVE SHEATH ON THE END OF THE INSTRUMENT.

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 LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT CLAIMED THAT THE ROBOTIC DEVICE IS DEFECTIVE AND THAT DURING THE COURSE OF THE SURGERY, THE PATIENT SUSTAINED SIGNIFICANT INJURIES TO THIS INTESTINES AND SMALL BOWELS BY THE USE OF THE DA VINCI SURGICAL ROBOT. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT THE ROBOTIC SURGERY WAS CONVERTED TO AN OPEN LAPAROTOMY SURGERY WITH REPAIR OF LACERATIONS AND TEARS OF THE INTESTINES AND SMALL BOWELS. THE LEGAL COMPLAINT ALSO CLAIMED THAT DUE TO THE LACERATIONS AND TEARS TO HIS SMALL BOWELS BY THE DA VINCI ROBOTIC SURGERY, THE PATIENT WOULD SPEND THE NEXT FORTY-FOUR DAYS IN THE HOSPITAL. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT DEVELOPED FEVERS, CONFUSION, ABDOMINAL DISTENSION AND TENDERNESS DUE TO HIS INJURIES, AND ALSO BOUTS OF SEPSIS, SUFFERED ABSCESSES AND GIANT FISTULA. AS A RESULT OF THE INJURIES, THE LEGAL COMPLAINT ALSO INDICATED THAT THE PATIENT HAD TO HAVE MULTIPLE ADDITIONAL OPERATIONS AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT 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 THAT UNDERWENT A DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011 FOR LOWER ANTERIOR RESECTION FOR OBSTRUCTING RECTOSIGMOID CANCER WHO SUBSEQUENTLY PASSED AWAY ON (B)(6) 2011. ISI WAS NOT PROVIDED WITH THE DA VINCI SURGICAL OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED BUT THEY ARE ALL RELATED TO SUBSEQUENT HOSPITALIZATIONS AND NON-ROBOTIC PROCEDURE. ULTIMATELY, THE PATIENT WAS FOUND TO HAVE EXPIRED AT HOME BY HIS SPOUSE ON (B)(6) 2011 AND AN AUTOPSY REPORT WAS 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 HOSPITAL AUTOPSY'S CLINICAL SUMMARY PROVIDED THE FOLLOWING INFORMATION: THE PATIENT HAD BEEN IN RELATIVELY GOOD HEALTH UNTIL (B)(6) 2011 AT WHICH TIME HE PRESENTED WITH MULTIPLE SYMPTOMS THAT INCLUDED GASTROINTESTINAL BLEEDING, ANEMIA, HYPONATREMIA, HYPERGLYCEMIA, AND FEBRILE ILLNESS. DURING HIS WORKUP, HE WAS ULTIMATELY FOUND TO HAVE NEARLY OBSTRUCTING RECTOSIGMOID MASS, AND UNDERWENT ROBOTIC LOW ANTERIOR RESECTION ON (B)(6) 2011, WITH SPLENIC

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 SI PROSTATECTOMY PROCEDURE SUSTAINED BLADDER AND PELVIC WALL INJURIES. REPORTEDLY THE INJURIES SUSTAINED BY THE PATIENT CAUSED A SMALL BOWEL OBSTRUCTION WITH FISTULA.

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 APRIL 16, 2012 ISI RECEIVED A LEGAL SUMMONS INDICATING ON (B)(6) 2011, THE PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE AT (B)(6). DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED INJURIES TO HER LEFT URETER AND BLADDER. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN LAPAROTOMY SURGERY WITH REPAIR OF THE BLADDER INJURY. THE PATIENT WAS GIVEN TWO UNITS OF PACKED RED BLOOD CELLS DUE TO BLOOD LOSS DURING SURGERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT BEGAN HAVING SEVERE PAIN IN HER BACK AND NOTICED THAT SHE WAS PASSING URINE THROUGH HER VAGINA. SECONDARY TO THIS, THE PATIENT WENT BACK TO THE HOSPITAL AND HAD RADIOLOGY TESTS PERFORMED WHICH, CONFIRMED THAT THE PATIENT HAD A URETERAL INJURY REQUIRING AN IMMEDIATE DIVERSIONARY NEPHROSTOMY TUBE TO BE PLACED BY A RADIOLOGIST. A PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED AND THE STENT WAS ABLE TO PASS FREELY INTO THE BLADDER. THE PATIENT WAS OUTFITTED WITH A NEPHROSTOMY BAG TO COLLECT HER URINE. THE PATIENT WAS THEN TAKEN BACK TO THE OPERATING ROOM AND THE URETERAL STENT IN THE LEFT URETER WAS INTERNALIZED. THIS ALLOWED FOR THE DISCONTINUATION OF THE NEPHROSTOMY BAG. ON (

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 TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR PERSISTENT POSTMENOPAUSAL VAGINAL BLEEDING ON (B)(6) 2011. 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. PATIENT WAS NOTED TO HAVE NORMAL EXTERNAL ANATOMY. LAPAROSCOPIC VISUALIZATION OF THE ABDOMEN AND PELVIS NOTED PARAOVARIAN ADHESIONS CONSISTENT WITH OLD INFLAMMATORY DISEASE. IT WAS ALSO NOTED THAT THERE WERE A FILMY CULD-DE-SAC ADHESIONS. THE UTERUS WAS NOTED AS UNREMARKABLE. THE FALLOPIAN TUBES WERE NOTED AS DEMONSTRATING PRIOR LIGATION. THE PATIENT WAS PLACED IN STANDARD POSITIONING FOR HYSTERECTOMY. A FOLEY CATHETER AND V-CARE UTERINE MANIPULATOR WERE PLACED. THE VERRES NEEDLE WAS INSERTED INTRAPERITONEALLY THROUGH A 12MM EPIGASTRIC INCISION. ALL PORTS WERE PLACED UNDER DIRECT VISUALIZATION IN 15MMHG OF INSUFFLATION. THE PROCEDURE FLOW WAS AS FOLLOWS: -OPENING OF THE PERITONEUM OVERLYING THE RIGHT PELVIC SIDEWALL -WIDE D

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 AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT HAD A LONG HISTORY OF DYSFUNCTIONAL BLEEDING, MENORRHAGIA, AND PELVIC PAIN. THE PATIENT HAS HAD PREVIOUSLY 9 LAPAROSCOPIES, ONE OF WHICH RESULTED IN A RIGHT SALPINGO OOPHORECTOMY. IN ADDITION, SHE HAS HAD 2 PRIOR CESAREAN SECTIONS. ACCORDING TO THE OPERATIVE REPORTS, THERE WAS A LITTLE BIT OF OOZING COMING FROM THE OMENTUM, WHEN PUTTING IN THE VERESS NEEDLE AND TROCAR. THE SURGEON NOTED SOME BLOOD AROUND THE OMENTUM; HOWEVER, NO OBVIOUS BOWEL OR OTHER INJURY WAS IMMEDIATELY APPARENT. THE SURGEON DECIDED TO CONTINUE WITH THE HYSTERECTOMY PROCEDURE UNTIL MORE OOZING WAS NOTED TO BE COMING FROM THE UPPER ABDOMINAL AREA. THERE WAS AN AREA OF HEMATOMA OVER THE SACRAL REGION OBSERVED FOR SEVERAL MINUTES. SINCE IT WAS NOT EXPANDING, A DECISION WAS MADE TO CONTINUE TO RECHECK IT. THE SURGEON COMPLETED THE HYSTERECTOMY PROCEDURE AND THEN WENT BACK TO RECHECK THE AREA OF HEMATOMA. THE SURGEON DECIDED TO CONSULT WITH A VASCULAR SURGEON. THE VASCULAR SURGEON INSPECTED THE AREA LAPAROSCOPICALLY 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 FROM A FACILITY IN EUROPE THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE AND WHILE PERFORMING PARA-AORTIC LYMPH NODE DISSECTION, THE SURGEON POSITIONED THE RIGHT MASTER TOOL MANIPULATOR (MTMR) TOWARD THE UPPERMOST BOUNDARY OF HIS AVAILABLE MTM WORKSPACE. THE SURGEON REMOVED HIS FINGERS FROM THE MTMR WHILE HIS HEAD WAS IN THE SURGEON CONSOLE VIEWER (CONTRARY TO A WARNING IN THE LABELING), AND THE INSTRUMENT ASSOCIATED WITH THE MTMR DROPPED DOWN IN AN UNCONTROLLED MANNER, AND CUT THE PATIENT'S ABDOMINAL AORTA. THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGERY AND THE PATIENT'S AORTA WAS REPAIRED BY PLACEMENT OF A STENT. THE PLANNED HYSTERECTOMY PROCEDURE WAS ALSO COMPLETED. AS OF THE DATE OF THIS REPORT, THE PATIENT IS REPORTED TO BE RECOVERING WITH NO COMPLICATIONS AND WAS DISCHARGED FROM THE HOSPITAL A WEEK AFTER THE OPERATION.

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 ON (B)(6), 2011 A PATIENT PASSED AWAY 18 MONTHS AFTER A DA VINCI S PROCEDURE TO REMOVE THE LOWER LOBE OF THEIR LEFT LUNG DUE TO BRONCHIOLOALVEOLAR CARCINOMA. ACCORDING TO THE PATIENT'S HUSBAND, DURING THE PROCEDURE, THE PATIENT'S STOMACH AND DIAPHRAGM WERE PUNCTURED RESULTING IN SEPSIS. THE PATIENT UNDERWENT A 5 MONTH HOSPITAL STAY AND EIGHTEEN MONTHS AS A NEAR INVALID. TO DATE, (B)(6) HAS NOT PROVIDED THE PATIENT'S HUSBAND WITH INFORMATION REGARDING THIS EVENT. INTUITIVE HAS CONTACTED THE SITES RISK MANAGEMENT DEPARTMENT, WHO ADVISED THAT THEY WOULD INVESTIGATE THIS EVENT AND RESPOND BACK TO INTUITIVE WITHIN THE UPCOMING WEEKS.

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 PANCREATECTOMY AND SPLENECTOMY PROCEDURE ON (B)(6) 2011. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT FOR THE DA VINCI SI SURGICAL PROCEDURE. THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2011. THERE WERE NO REPORTS OF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE SURGICAL PROCEDURE. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO A HOSPITAL FOR A REPORTED COMPLAINT OF GRADUALLY WORSENING ABDOMINAL PAIN. A CT SCAN REVEALED THAT THE PATIENT HAD POST-OPERATIVE AND RECURRENT PANCREATITIS. THE CT SCAN ALSO FOUND SMALL CYSTIC MASSES ON THE PANCREAS. ON (B)(6) 2011, THE PATIENT UNDERWENT A PANCREATIC DEBRIDEMENT PROCEDURE AS WELL AS DEBRIDEMENT OF MULTIPLE PERIPANCREATIC ABSCESSES. TWO DRAINS WERE PLACED DURING THE PROCEDURE. THE OPERATIVE REPORT INDICATED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WITHOUT COMPLICATIONS. ACCORDING TO THE PATIENT'S MEDICAL RECO

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. RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI RIGHT ANTEGRADE PERCUTANEOUS URETEROSCOPY WITH STONE MANIPULATION (NON-ROBOTIC) FOLLOWED BY A ROBOTIC-ASSISTED BILATERAL URETERO NEOCYSTOSTOMIES WITH BILATERAL URETERAL STENT PLACEMENTS AND RIGHT PSOAS HITCH FOR REPAIR OF A PRIOR URETERAL INJURY ON (B)(6) 2011. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THE LEFT URETER WAS INADVERTENTLY CUT AND SUBSEQUENTLY REPAIRED BY THE SURGEON. THE PATIENT WAS DISCHARGED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WAS A REPORT OF A POST-OPERATIVE COMPLICATION, SPECULATED TO BE THE RESULT OF PATIENT ARM POSITION DURING THE 7 1/2 HOUR PROCEDURE. UPON WAKING UP FROM THE SURGERY ON (B)(6) 2011 THE PATIENT PRESENTED WITH BLISTERING AND UPPER EXTREMITY PAIN THAT WAS SIGNIFICANTLY REDUCED IN THE HOURS FOLLOWING THE PROCEDURE. COMPARTMENT SYNDROME, WHILE INITIALLY SUSPECTED, WAS SUBSEQUENTLY RULED OUT. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF THE 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: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL LAPAROSCOPIC HYSTERECTOMY WITH LEFT SALPINGO-OOPHORECTOMY AND RIGHT SALPINGECTOMY AND DIAGNOSTIC CYSTOSCOPY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS FOUND TO HAVE BOWEL ADHESIONS TO THE ANTERIOR UTERINE SURFACE AND OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL DURING THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2011. THE OPERATIVE REPORT STATES THAT GREAT USE OF CAUTERY WAS USED DURING THE PROCEDURE. A DIAGNOSTIC CYSTOSCOPY WAS PERFORMED AND FOUND TO BE UNREMARKABLE. THE DIAGNOSTIC CYSTOSCOPY ALSO REVEALED GOOD FLOW FROM BOTH URETERAL ORIFICES. THE PATIENT WAS REPORTEDLY DISCHARGED ON AN UNSPECIFIED DATE AFTER AN UNREMARKABLE STAY. ON AN UNSPECIFIED DATE IN LATE (B)(6) 2011, THE INFORMATION INDICATED THAT THE PATIENT BEGAN EXPERIENCING BROWN VAGINAL DISCHARGE AS WELL AS FLATULENCE FROM HER VAGINA. BASED ON VISITS WITH A PHYSICIAN IN LATE (B)(6) 2011, THE PHYSICIAN NOTED THAT THE PATIENT WAS HAVING INTERCOURSE WITH HER SPOUSE. HOWEVER, THE PATIENT ADAMANTLY DENIED THAT THIS WAS THE CASE

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH LYSIS OF ADHESIONS ON (B)(6) 2011. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF CHRONIC PELVIC PAIN, CHRONIC BACK PAIN, AND AN ENLARGED UTERUS. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI SURGICAL PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THERE WERE NO REPORTS THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE PROCEDURE. AFTER LYSIS OF ADHESIONS WAS PERFORMED BY THE SURGEON, COPIOUS IRRIGATION OF THE PELVIS WAS RE-PERFORMED AND THE PELVIS WAS AGAIN NOTED TO BE HEMOSTATIC. THE SURGEON STATED THAT AFTER THE UTERUS WAS REMOVED THROUGH VAGINA WITHOUT DIFFICULTY, THE PELVIS WAS COPIOUSLY IRRIGATED AND FOUND TO BE HEMOSTATIC. THE PATIENT'S VAGINAL CUFF WAS THEN CLOSED WITH A V-LOC SUTURE IN A RUNNING FASHION. THE PATIENT WAS EXTUBATED WITHOUT DIFFICULTY. SHE WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. POST-OPERATIVELY, THE PATIENT WAS FOUND TO BE ACUTELY HYPOTE

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 RECEIVED A TELEPHONE MESSAGE FROM A PATIENT WHO UNDERWENT A DA VINCI SI OVARIAN CYST REMOVAL PROCEDURE ON (B)(6) 2011. THE PATIENT REPORTED THAT DURING THE SURGICAL PROCEDURE SHE SUSTAINED INJURIES AND THAT POST-OPERATIVELY, SHE HAS CONTINUED TO EXPERIENCE PAIN. THE PATIENT INDICATED THAT SHE IS ONLY ABLE TO GET OUT OF BED TO GO TO THE HOSPITAL OR DOCTOR'S APPOINTMENTS. THE PATIENT UNDERWENT A POST-OPERATIVE CHECK UP WITH THE SURGEON; HOWEVER, SHE HAS NOT HAD ANY SUBSEQUENT CARE BY THE SURGEON SINCE THAT TIME. DURING A FOLLOW-UP WITH AN ASSOCIATE PHYSICIAN, THE PATIENT WAS TOLD THAT MORE DAMAGE WOULD OCCUR IF SHE UNDERWENT ANOTHER SURGICAL PROCEDURE. PER THE INFORMATION PROVIDED BY THE PATIENT, FOR THE LAST TWO YEARS SINCE THE SURGERY, SHE HAS NOT HAD A LIFE.

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 LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT WAS ADMITTED WITH THE DIAGNOSIS OF SYMPTOMATIC UTERINE FIBROIDS WITH ANEMIA SECONDARY TO ABNORMAL UTERINE BLEEDING. ACCORDING TO THE OPERATIVE REPORT, NEAR THE CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT RECEIVED INDIGO CARMINE AND A SPILL FROM THE BLADDER WAS OBSERVED. THE SURGEON THEN PLACED 180 ML OF METHYLENE BLUE DILUTED IN NORMAL SALINE INTO THE BLADDER AND NO LEAKAGES WERE OBSERVED FROM THE BLADDER OR THE URETERS INSIDE THE PELVIS. THE BLADDER WAS ALSO FOUND TO BE INTACT DURING A CYSTOSCOPIC EXAMINATION OF THE BLADDER. THE SURGEON NOTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND SHE WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL COMPLAINING OF ABDOMINAL PAIN ASSOCIATED WITH NAUSEA, VOMITING, AND DIARRHEA. THE PATIENT WAS ALSO FOUND TO HAVE PROFOUND DEHYDRATION AND LOW-GRADE FEVER. A CAT SCAN OF THE PATIENT'S ABDOMEN R

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) 2011. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED A LEFT URETER CAUTERY INJURY DURING THE PROCEDURE. THE REPORTED INJURY PREVENTED A SUCCESSFUL POST-OPERATIVE STENT AND THE PATIENT WAS REQUIRED TO UNDERGO AN URETERAL REIMPLANTATION ON AN UNSPECIFIED DATE. DETAILS REGARDING THE EVENTS LEADING TO THE PATIENT'S REPORTED INJURIES WERE NOT REPORTED. THE LEGAL DOCUMENT PROVIDES A DA VINCI SYSTEM SERIAL ; HOWEVER, THE SYSTEM SERIAL IS INCORRECT SINCE THE SYSTEM SERIAL IS NOT ASSOCIATED WITH THE REPORTED SITE'S NAME. AT THIS TIME, THE SYSTEM SERIAL ASSOCIATED WITH THE REPORTED PROCEDURE CANNOT BE CONFIRMED. ISI ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT GROUP TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

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 AND UTEROSACRAL LIGAMENT VAGINAL VAULT SUSPENSION PROCEDURE ON (B)(6) 2011 FOR A 20-WEEK LEIOMYOMATOUS UTERUS AND STAGE 1 UTEROVAGINAL PROLAPSE MENOMETRORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE URETERS WERE IDENTIFIED IN THE BROAD LIGAMENT. ESTIMATED BLOOD LOSS WAS 100 ML. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN EXCELLENT CONDITION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ON (B)(6) 2011, THE PATIENT PRESENTED WITH A LARGE AMOUNT OF FLUID DRAINAGE FROM THE VAGINA. A PREVIOUS METHYLENE BLUE TEST WAS NEGATIVE FOR VESICOVAGINAL FISTULA. A CYSTOSCOPY WAS PERFORMED AS WERE BILATERAL PYELOGRAMS. THE LEFT RETROGRADE PYELOGRAM SHOWED MEDIAL EXTRAVASATION OF CONTRAST AND SCAR TISSUE A THE DISTAL MOST 3CM. IT WAS NOTED THAT IT WAS EXTREMELY DIFFICULT TO IDENTIFY THE TRUE LUMEN OF THE URETER. PLACEMENT OF A URETERAL STENT FAILED SO A NEPHROSTOMY TUBE WAS PLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2011

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 AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE WITH LYSIS OF ADHESIONS AND CYSTOSCOPY ON (B)(6) 2011. THE CYSTOSCOPY AND RIGHT RETROGRADE PYELOGRAM WAS PERFORMED FOR HYDRONEPHROSIS BEFORE THE DA VINCI SURGICAL PROCEDURE BEGAN. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S URETERAL ORIFICES APPEARED NORMAL. THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS DYSMENORRHEA, PELVIC PAIN, AND OVARIAN CYST. THE PATIENT HAD A LONG HISTORY OF DYSMENORRHEA AND GASTROINTESTINAL ISSUES. THE OPERATIVE REPORT STATED THAT THE PATIENT HAD A NORMAL-APPEARING LEFT OVARY, SURGICALLY ABSENT RIGHT OVARY, RIGHT HYDRONEPHROSIS AND HISTORY OF RIGHT OVARIAN CYST. THERE WAS ALSO PELVIC SCARIFICATION DUE IN PART TO SIGNIFICANT ENDOMETRIOSIS AND NORMAL OVARY WITH A SMALL CYST. NO COMPLICATIONS WERE NOTED FOR BOTH PROCEDURES. THE PATIENT WAS DISCHARGED HOME 2 DAYS AFTER THE SURGERY ON (B)(6) 2011. APPROXIMATELY, 1 WEEK AFTER THE PROCEDURE ((B)(6) 2011), SHE CONTACTED THE DOCTOR AND REPORTED BURNING WITH URINATION AND LOW GRADE TEMPERATURE. SHE WAS PRESCRIBED CIPRO. ON (B)(6) 2011, THE PATIENT

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 WITH DRAINAGE OF TWO RIGHT OVARIAN CYSTS AND CYSTOSCOPY PROCEDURE ON (B)(6) 2011 FOR PELVIC PAIN AND MENOMETRORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. A PATHOLOGY REPORT OF THE REMOVED SPECIMENS WAS ALSO PROVIDED. 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. WHEN THE PATIENT WAS PRESENTED WITH THE OPTION OF A LAPAROSCOPIC EXAM AND ABLATION SHE ADAMANTLY DESIRED A HYSTERECTOMY. THIS WAS A STANDARD SURGERY WITH THE EXCEPTION OF DRAINAGE OF TWO CYSTS ON THE PATIENT'S RIGHT OVARY. AS THE LEFT OVARY HAD BEEN REMOVED DURING A PRIOR SURGERY, THE REMAINING PORTION OF THE LEFT TUBE WAS SURGICALLY REMOVED DURING THE HYSTERECTOMY PROCEDURE. CYSTOSCOPY WAS PERFORMED, WITH INDIGO CARMINE EFFLUXING FROM BOTH URETERAL ORIFICES. THE PATIENT WAS TAKEN TO THE PACU IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT PRESENTED WITH POSTOPERATIVE BLEEDING AND WAS DIAGNOSED WITH VAGINAL DEHISCENCE. A 1.5-2CM OPENING AT THE VAGINAL CUFF

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 AND THE MEDICAL RECORDS OF A PATIENT WHO PLANNED FOR ROBOTIC ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ,BUT WAS CONVERTED TO LAPAROTOMY DUE TO INTRA-OPERATIVE COMPLICATION. THE PATIENT WAS ADMITTED IN THE HOSPITAL ON (B)(6) 2011 FOR ENDOMETRIAL HYPERPLASIA. DURING THE TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011, THE 8MM TROCAR WAS PLACED IN THE ABDOMEN BUT ITS TIP COULD NOT BE IDENTIFIED. AFTER FURTHER EVALUATION, THE TROCAR WAS PLACED THROUGH THE ADHESIONS ON THE SCAR THAT THE PATIENT ACQUIRED FROM THE PREVIOUS CHOLECYSTECTOMY. THE SURGEON PULLED RIGHT SIDED 8MM TROCAR. AT THE EVALUATION OF THE TROCAR, SURGEON NOTICED MATERIAL ON ITS TIP RESEMBLING STOOL. THE DECISION WAS TO PROCEED WITH A LAPAROTOMY. THE PATIENT HAD BEEN OOZING MORE THAN TYPICAL,DUE TO THE PATIENT BEING ON PLAVIX. THE PATIENT'S BOWEL WAS PACKED CEPHALAD WITH MOIST LAPAROTOMY SPONGES. THE PATIENT'S INJURY WAS REPAIRED. THE PATIENT TOLERATED THE PROCEDURE WELL. POST-OPERATIVELY, THE PATIENT HAD MENORRHAGIA REQUIRING MULTIPLE BLOOD TRANSFUSIONS AND SUBSEQUENTLY BECAME HYPOTOXOIC. THE PATIENT HAD A CHEST X-RAY P

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 CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. THE PROVIDED DOCUMENT STATED THAT THE PATIENT SUSTAINED PERFORATIONS OF THE SMALL BOWEL DURING THE SURGICAL PROCEDURE. THE PATIENT'S OPERATIVE REPORT, DATED (B)(6) 2011, NOTED THAT THE PATIENT HAD SIGNIFICANT COMORBIDITIES AND PRIOR SURGERIES OF EXPLORATORY LAPAROTOMY, COLECTOMY, COLOSTOMY AND CLOSURE OF COLOSTOMY. THE SURGEON INCLUDED IN THE OPERATIVE REPORT THAT THE PATIENT HAD SEVERE ADHESIONS PARTICULARLY ON THE LEFT SIDE WHERE THE COLOSTOMY WAS PRESENT. THE ROBOTIC PORTS WERE PLACED IN A SPECIFIC WAY TO TAKE DOWN THE ADHESIONS. THE PROVIDED DOCUMENT STATED THAT WITH MINIMAL CAUTERY THE ADHESIONS WERE TAKEN DOWN IN ORDER FOR THE ROBOTIC PORTS TO ALL BE PLACED, EXCEPT FOR THE ONE ON THE LEFT HAND SIDE. THE SURGEON WAS ABLE TO PERFORM LYSIS OF THE ADHESIONS TO GAIN ADEQUATE EXPOSURE OF THE PROSTATE GLAND. THE LEFT SIDED ADHESIONS WERE NOT FULLY TAKEN DOWN. THE REMAINDER OF THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DIFFICULTIES. THE OPERATIVE NOTE INDICAT

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 PELVIC PAIN AND DYSMENORRHEA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES DISCHARGE SUMMARIES, HISTORY AND PHYSICAL, ADDITIONAL OPERATIVE REPORTS,AND PATHOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION. THE BLADDER WAS UNINTENTIONALLY ENTERED DURING THE DISSECTION OF THE SCAR TISSUE BETWEEN THE BLADDER AND THE VAGINA. ON (B)(6) 2011, THE PATIENT UNDERWENT A DAVINCI ROBOTIC HYSTERECTOMY PROCEDURE. IT WAS NOTED THAT THERE WAS ADHESIONS BETWEEN LOWER UTERINE SEGMENT AND BLADDER FROM PREVIOUS CESAREAN SECTIONS. INCIDENTAL CYSTOSTOMY REPAIRED DURING SURGERY. THE CYSTOTOMY WAS REPAIRED ROBOTICALLY AT THE TIME OF THE INITIAL SURGERY. SUBSEQUENTLY AT HOME THE PATIENT NOTED URINARY INCONTINENCE AND LEAKING URINE THROUGH THE VAGINA. ON (B)(6) 2011 THE PATIENT UNDERWENT CYSTOSCOPY WITH RETROGRADE PYELOGRAPHY. THE PATIENT WAS DIAGNOSED WITH A VESICOVAGINAL

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 APRIL 4, 2012 INTUITIVE SURGICAL WAS CONTACTED BY THE PATIENT'S GRAND-DAUGHTER THAT THE PATIENT UNDERWENT A KIDNEY BIOPSY PROCEDURE USING THE DA VINCI S SURGICAL SYSTEM ON (B)(6) 2011. REPORTEDLY, DURING THE BIOPSY PROCEDURE, THE PATIENT'S RENAL ARTERY WAS DAMAGED. THE PLANNED PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES TO REPAIR THE AFFECTED VESSEL AND THE PATIENT REQUIRED A PARTIAL NEPHRECTOMY AS A RESULT OF THE DAMAGE. THE PATIENT LOST 13 PINTS OF BLOOD. ON (B)(6) 2012, THE PATIENT EXPIRED DUE TO PNEUMONIA, MULTIPLE ORGAN FAILURE AND RENAL FAILURE.

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) 2011 FOR VAGINAL BLEEDING PROBLEM FROM A FIBROID UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. 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) 2011, SHE WAS READMITTED FOR ABDOMINAL PAIN, FEVER AND FOUND TO HAVE PERITONITIS. MULTIPLE ENTEROTOMIES WERE FOUND AFTER EXPLORATORY LAPAROTOMY. A COLOSTOMY WAS REQUIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT DEVELOPED A DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. ON (B)(6) 2011, A TAKEDOWN OF COLOSTOMY AND CREATION OF ILEOSTOMY WAS PERFORMED. ON (B)(6) 2012, A REVERSAL OF ILEOSTOMY WAS PERFORMED. NO OTHER 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: A PT TREATED FOR A MID-PARENCHYMAL LEFT LOWER LOBE MASS EXPERIENCED A COLLAPSE OF THE LEFT LOWER LOBE EIGHT MONTHS AFTER TREATMENT. THIS EVENT IS CONSIDERED A KNOWN RISK OF TREATING SUCH A TUMOR IN THIS LOCATION AND IS NOT ATTRIBUTED TO MALFUNCTION OF THE CYBERKNIFE SYSTEM. THE PT HAS DEMONSTRATED FAVORABLE RESPONSE TO TREATMENT WITH MARKED REGRESSION IN TUMOR SIZE AND IMPROVED CONTROL OF DISEASE.

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 UNDERGOING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE ON (B)(6) 2011, THE PATIENT CLAIMED THAT HE HAS BEEN "COMPLETELY INCONTINENT." ACCORDING TO THE PATIENT, THE SURGEON¿S OPERATIVE REPORT NOTED NO COMPLICATIONS. PER THE PATIENT, A NURSING NOTE INDICATED HE HAD ¿EXTRAORDINARILY STRONG PAIN IN THE ABDOMINAL CAVITY AFTER THE OPERATION.¿ THE PATIENT WAS DISCHARGED ON (B)(6) 2011, WITH A ¿LYING BLADDER CATHETER.¿ THE CATHETER WAS REMOVED ON AN UNSPECIFIED DATE AT A REHABILITATION CLINIC AND ¿CLEAR URINARY INCONTINENCE WAS OBSERVED.¿ FOUR WEEKS POST-OPERATIVELY, THE PATIENT CLAIMED THAT ¿20-25 URINARY CATHETERS WERE NEEDED PER DAY.¿ SIX MONTHS POST-OPERATIVELY, THE PATIENT INDICATED THAT 15 CATHETERS WERE NEEDED. ON (B)(6) 2012, THE PATIENT REPORTEDLY UNDERWENT ¿URODYNAMIC TESTING¿ BY A PHYSICIAN AT ANOTHER HOSPITAL. THE PATIENT INDICATED THAT THE PHYSICIAN NOTED THE FOLLOWING IN HIS MEDICAL REPORT: ¿THERE¿S COMPLETE INCONTINENCE AFTER RADICAL PROSTATECTOMY WITH DAVINCI.¿ IN RELATION TO A LOW FILLING CAPACITY OF THE BLADDER, THE PATIENT QUESTIONED AS TO WHETHER "SERIOUS ERRORS WERE MADE IN THE RECONSTRUCTION OF THE BLADDER NECK."

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 RECEIVED INFORMATION INCLUDING A MEDICAL SUMMARY REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY ON (B)(6) 2011. THE MEDICAL HISTORY SUMMARY STATES THAT THIS PATIENT WAS PLANNED TO UNDERGO A DA VINCI HYSTERECTOMY WITH PLANNED URETERAL STENT PLACEMENT. THE PATIENT HAD EVIDENCE OF NORMAL URETHRA AND BLADDER. THE URETERAL STENTS WERE PLACED SUCCESSFULLY BY THE UROLOGIST AND FOLEY CATHETER WAS PLACED AT THE END OF THE PROCEDURE. THE PATIENT WAS RE-OPENED FOR THE DA VINCI HYSTERECTOMY PROCEDURE. THE MEDICAL HISTORY SUMMARY STATES THAT THE SURGEON WHO WAS PERFORMING THE HYSTERECTOMY PROCEDURE NOTED AN APPROXIMATELY 1-1.5CM OF BLADDER CYSTOTOMY WHILE PERFORMING THE ANTERIOR COLPOTOMY. THE BLADDER CYSTOTOMY WAS REPAIRED WITH NO FURTHER COMPLICATION. THE SURGEON MADE THE DECISION TO PERFORM A SUPRACERVICAL HYSTERECTOMY TO AVOID ANY ADDITIONAL TRAUMA OR INJURY TO THE PATIENT'S BLADDER. THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE MEDICAL HISTORY INFORMATION PROVIDED, PRIOR TO THE DA VINCI SURGICAL SYSTEM BEING DOCKED TO THE PATIENT, THE PATIENT UNDERWENT A PLANNED BLADDER CYSTOSCOPY WITH PLACEMEN

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) 2011. 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. 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: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT ALLEGED THAT THE USAGE OF THE DA VINCI ROBOT RESULTED IN AN INJURY TO THE BLADDER, WHICH CAUSED THE CLIENT TO ENDURE OVER A YEAR OF PAIN, MEDICATION, DOCTORS' VISITS, AND FINALLY ANOTHER SURGERY TO FURTHER CORRECT THE DAMAGE DONE BY THE DA VINCI.

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 LAPAROSCOPIC SIGMOID COLECTOMY WITH RECTOPEXY FOR CHRONIC RECTAL PROLAPSE ON (B)(6) 2011. THE PATIENT HAD A CONDITION OF CHRONIC SMALL BOWEL OBSTRUCTION PRIOR TO HER SURGERY FOR RECTAL PROLAPSE. INTUITIVE SURGICAL, INC. (ISI) WAS PROVIDED WITH THE OPERATIVE REPORT FROM (B)(6) 2011. ADDITIONAL INFORMATION PROVIDED INCLUDES CLINIC NOTES (B)(6) 2011, ER VISIT (B)(6) 2011, HOSPITAL ADMISSION (B)(6) 2011, CT SCAN (B)(6) 2011, ABDOMINAL X-RAY (B)(6) 2011, CT SCAN (B)(6) 2011, CT SCAN (B)(6) 2011, CT SCAN (B)(6) 2011, X-RAY (B)(6) 2011, ER VISIT (B)(6) 2011, CT (B)(6) 2011, X-RAY (B)(6) 2011, CLINIC NOTE (B)(6) 2011, AND COLONOSCOPY (B)(6) 2010. THERE WAS NO ALLEGATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ACCORDING TO THE OPERATIVE REPORT, THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER THE PROLAPSE SURGERY, HER RECOVERY WAS PROLONGED BY THE DEVELOPMENT OF A POSSIBLE ABSCESS IN THE PRE-SACRAL AREA FOR WHICH SHE WAS ADMITTED TO A HOSPITAL. SHE WAS TREATED WITH ANTIBIOTICS AND DRAINAGE BEGINNING (B)(6) 2011. SHE

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 SI HYSTERECTOMY, LEFT SALPINGO-OOPHORECTOMY AND ABLATION OF ENDOMETRIOSIS PROCEDURE ON (B)(6) 2011. THERE WAS NO REPORT IN THE PATIENT'S OPERATIVE (OP) REPORT THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORIES OCCURRED OR THAT THE PATIENT EXPERIENCED ANY INTRA-OPERATIVE COMPLICATIONS. ACCORDING TO THE OP REPORT, AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED, EXCELLENT HEMOSTASIS WAS NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM (ER) COMPLAINING OF ABDOMINAL PAIN, HAD A FEVER OF 101 AND HAD DRY NON-PRODUCTIVE DRY COUGH. THE PATIENT DENIED ANY ABNORMAL VAGINAL DISCHARGE, VOMITING OR DIARRHEA. REPORTEDLY, A CHEST X-RAY WAS PERFORMED. THE FINDINGS WERE NORMAL. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL'S ER ON (B)(6) 2011 COMPLAINING OF RIGHT SIDED PELVIC PA

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 HYSTERECTOMY WITH BILATERAL SALPINGOOPHERECTOMY FOR OVARIAN SUPPRESSION DUE TO BREAST CANCER ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION NAMELY AN INADVERTENT CYSTOTOMY WHICH WAS REPAIRED PRIMARILY, AND DID NOT CONTRIBUTE TO THE SUBSEQUENT ADVERSE EVENT, NAMELY THE VAGINAL CUFF DEHISCENCE. ON (B)(6) 2011, THE PATIENT NOTED AN EPISODE OF PAIN AND VAGINAL BLEEDING AND WAS FOUND TO HAVE A VAGINAL CUFF DEHISCENCE AND SOME DEGREE OF EVISCERATION (RECORDS ARE HANDWRITTEN). THIS WAS REPAIRED VIA LAPAROTOMY ON (B)(6) 2011 THE PATIENT PRESENTED WITH SYMPTOMS OF VAGINAL BLEEDING AND WAS FOUND TO HAVE A 1CM AREA AT THE TOP OF THE VAGINA THAT WAS OPENING AGAIN. THIS WAS CALLED A DEHISCENCE AND THE PATIENT WAS TAKEN ONCE AGAIN FROM A LAPAROTOMY. MESH WAS PLACED AT THE TOP OF THE VAGINA TO HOPEFULLY PREVENT ANOTHER SIMILAR INCIDENT.

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. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO REPORTED TO HAVE POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE PATIENT'S OPERATIVE (OP) REPORT FOR THE SURGICAL PROCEDURE OF (B)(6) 2011, STATES THAT DURING THE VINCI TOTAL HYSTERECTOMY, THE PATIENT PRESENTED SOME OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL THAT WERE EASY TO LYSE, OTHERWISE NORMAL APPEARING UTERUS, TUBES AND OVARIES. THE PATIENT'S CERVIX AND UTERUS WERE REMOVED WITHOUT COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT PRESENTED TO THE DOCTOR OFFICE FOR A POST-OPERATIVE VISIT. PATIENT WAS DOING WELL WITH NO COMPLAINTS. PER THE MEDICAL RECORDS, ON (B)(6) 2011,THE PATIENT RETURNED TO HER DAILY ROUTINE AND SHE REPORTED HAVING HEAVY BLEEDING AND PASSING CLOTS. PATIENT WAS ADMITTED TO THE EMERGENCY ROOM, TO REPAIR THE CUFF DEHISCENCE. THE PATIENT 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: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT DEVELOPED A PELVIC ABSCESS AS A RESULT OF UNDERGOING THE SURGICAL PROCEDURE AND WAS HOSPITALIZED. THE PATIENT'S PROCEDURE NOTES STATE THAT THE PRE-OPERATION DIAGNOSIS WAS SYMPTOMATIC UTERINE FIBROIDS, PELVIC PAIN, AND MENOMETRORRHAGIA. THE PATIENT WAS NOTED TO HAVE A RELATIVELY LARGE UTERUS, APPROXIMATELY 16 WEEKS WITH ONE LARGE "FUNDUAI" FIBROID. OVARIES AND TUBES REPORTED TO BE NORMAL. AFTER REMOVAL OF THE UTERUS, A SMALL VAGINAL LACERATION WAS NOTED TO BE REPAIRED WITH 2.0 VICRYL WITHOUT INCIDENT. THE VAGINAL CUFF WAS CLOSED USING THE V-LOC RUNNING SUTURE WITH REPORTED EXCELLENT CLOSURE. THERE WERE NO SIGNS OF LEAKAGE OF URINE AND NO REPORTED EVIDENCE OF INJURY. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 (ONE DAY AFTER SURGERY) WITH NO REPORTED COMPLICATIONS. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM WITH SY

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 WHO UNDERWENT A DA VINCI S PROSTATECTOMY ON (B)(6) 2011 DUE TO PROSTATE CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION WAS PROVIDED INCLUDED THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION IN THE PATIENT'S OPERATIVE REPORT, THE SURGEON ENCOUNTERED EXTENSIVE ADHESIONS THROUGHOUT THE PATIENT'S PELVIS DURING CREATION OF THE PATIENT'S PORT SITES. THE ADHESIONS WERE TAKEN SHARP AND CAUTERY DISSECTION. AFTER THE ADHESIONS WERE TAKEN DOWN, THE DA VINCI SURGICAL SYSTEM WAS DOCKED TO THE PATIENT. REPORTEDLY, THE PATIENT TOLERATED THE SURGICAL PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN GOOD CONDITION. THE ESTIMATED BLOOD LOSS WAS 250CC. ACCORDING TO THE PATIENT'S CLAIM FORM, ON (B)(6) 2011 THE PATIENT UNDERWENT EXPLORATORY CELIOTOMY WITH EXTENSIVE LYSIS OF ADHESIONS AND SMALL BOWEL RESECTION. THE PATIENT UNDERWENT A CT SCAN WITH ORAL CONTR

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 S PROSTATECTOMY PROCEDURE A VERY SMALL AMOUNT OF BLOOD WAS OBSERVED ON THE PATIENT'S DESCENDING COLON, AROUND THE SIGMOID. ANOTHER SURGEON WAS BROUGHT IN TO ASSESS THE ISSUE AND CONFIRMED THAT THE PATIENT'S BOWEL HAD BEEN PERFORATED. SINCE THE DAMAGE WAS LOCATED ON THE UNDERSIDE OF THE PATIENT'S BOWEL, VISIBILITY WAS LIMITED AND THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO REPAIR THE DAMAGED BOWEL AND COMPLETE THE PLANNED PROCEDURE. POSTOPERATIVELY, 4 UNITS OF BLOOD WERE GIVEN TO THE PATIENT TO HELP WITH THEIR BOWEL RECOVERY AND BLEEDING FROM THE DEEP DORSAL VEIN COMPLEX. IT WAS REPORTED THAT THE PATIENT IS IN STABLE CONDITION.

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 AND MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE HYSTERECTOMY OPERATIVE REPORT, THE PATIENT'S PREOPERATIVE AND POSTOPERATIVE DIAGNOSES WERE NOTED AS MENORRHAGIA. THE OPERATIVE REPORT INDICATED THAT THE PATIENT'S UTERUS WAS NORMAL IN SIZE AND THE OVARIES WERE COMPLETELY NORMAL BILATERALLY. AFTER THE UTERUS WAS REMOVED VAGINALLY, ALL PEDICLES WERE INSPECTED. HEMOSTASIS WAS NOTED AND BOTH URETERS WERE FOLLOWED FROM THE PELVIC SIDEWALL. THE PATIENT'S URINE WAS DRAINING ADEQUATELY AND CLEAR. NO COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6) 2011. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. ON (B)(6) 2011 (APPROXIMATELY 3.5 MONTHS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE), THE PATIENT HAD COMPLAINTS OF VAGINAL BLEEDING AND ABDOMINAL PAIN AFTER INTERCOURSE IN THE MORNING. THE PATIENT WAS TRANSPORTED TO THE DOCTOR'S OFFICE AND THEN TO THE EMERGENCY ROOM VIA AN EMERGENCY MEDICAL SERVICE. WHEN SHE ARRIVED AT THE EMERGENCY ROOM (ER), HER ABDO