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 HYSTERECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE PATIENT'S MEDICAL RECORDS, SHE SUSTAINED A SMALL RENT/TEAR IN THE POSTERIOR WALL OF THE BLADDER. ISI HAS REVIEWED THE MEDICAL RECORDS FOR THE PATIENT. BASED ON THE OPERATIVE REPORT OF THE HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, THERE IS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT AFTER CLOSING OFF THE VAGINAL CUFF WITH THE SUTURE, WE THEN PLACED INDIGO CARMINE IN THE PATIENT'S VESSELS. THE SURGEON ALSO INDICATED, WE THEN PERFORMED A CYSTOSCOPY AFTER WE REMOVED ALL THE TROCARS UNDER DIRECT VISUALIZATION. AT THE CYSTOSCOPY, BOTH URETERS WERE NOTED TO BE EJECTING INDIGO CARMINE. WE THEN SAW A SMALL LITTLE HOLE, PIN SIZE HOLE. THE OPERATIVE REPORT INDICATED THAT AN INTRAOPERATIVE CONSULT WAS PERFORMED BY A SURGEON FROM UROLOGY AND IT WAS CONFIRMED THAT THERE WAS AN INCIDENTAL CYSTOTOMY. THE PATIENT'S INCISION SITES WERE THEN REOPENED AND 2 ROBOTIC TROCARS WERE USED IN THE LATERAL PORTS 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: THE FOLLOWING PATIENT COMMENTS WERE FOUND POSTED ON INTUITIVE SURGICAL'S MARKETING FEEDBACK PATIENT SURVEY WEBSITE CONCERNING THE OUTCOME OF THEIR DA VINCI SURGICAL PROCEDURE: I DIDN'T RECOVER AS QUICKLY AS I THOUGHT. I WASN'T FULLY PREPARED FOR THE INCONTINENCE. I ALSO DEVELOPED A LEFT HIP PAIN THAT LASTED FOR A MONTH, MAYBE MORE BECAUSE I AM STILL IN RECOVERY. DOCTORS AREN'T SURE IF THE HIP PAIN IS RELATED TO THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDE. LATE SUBMISSION OF THIS MEDWATCH REPORT IS DUE TO AN OVERSIGHT DURING REVIEW OF THE SURVEY BY ISI MARKETING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI S HYSTERECTOMY PROCEDURE WAS SUBMITTED TO INTUITIVE SURGICAL ON (B)(6) 2012 THROUGH THE (B)(4) WEBSITE: MY EXPERIENCE WAS HORRIFIC. I HAD A RADICAL HYSTERECTOMY FOR CERVICAL CANCER. MY FAMILY WAS UNSUPPORTIVE AS WELL. I WOULD NOT EVER RECOMMEND DA VINCI. AND I CERTAINLY WOULD NOT RECOMMEND THE HOSPITAL WHERE MY SURGERY WAS PERFORMED. I WAS NOT PROVIDED ANY INFORMATION ABOUT WHAT TO EXPECT. THE ADMITTING NURSES DID NOT COMPLETE ALL PAPERWORK FOR PROPER ADMITTANCE. I WAS GIVEN TOO MUCH ANESTHESIA AND NOT FULLY RECOVERED IN THE RECOVERY ROOM. WHILE STILL GROGGY FROM SURGERY I WAS ASKED ALL KINDS OF MEDICAL QUESTIONS AND DIDN'T KNOW WHAT WAS GOING ON, WHICH I THINK IS JUST RIDICULOUS OF A MEDICAL STAFF. I WAS IN ICU FOR 1 DAY AND THERE WAS A TOTAL LACK OF PRIVACY FOR URINATING ONCE THE CATHETER WAS REMOVED. AT 10 WEEKS POST SURGERY, I HAD TO HAVE SURGERY AGAIN DUE TO VAGINAL CUFF DEHISCENCE. MY RECOVERY TIME WAS DOUBLE - MY HOSPITAL BILLS WERE MORE THAN DOUBLE. THE VAGINAL CUFF DEHISCENCE WAS VERY SCARY. I WAS A GREAT AMOUNT OF PAIN FOR 6 DAYS PRIOR TO THE SECOND SURGERY. THE RECOVERY TIMES FOR BOTH SURGERIES WERE MUCH LONGER THAN ADVER

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING POST-OPERATIVE TRAUMA AND HEMORRHAGING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR PELVIC MASS AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2012 DUE TO CARDIOPULMONARY COLLAPSE. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT ALONG WITH FOLLOW-UP HOSPITAL REPORTS. ACCORDING TO THE DA VINCI SURGERY OPERATIVE REPORT DATED (B)(6) 2012, THE PATIENT HAS A HISTORY OF A LIVER TRANSPLANT AND CROHN'S DISEASE. DURING SURVEILLANCE OF HER LIVER TRANSPLANT IN (B)(6) 2011, AN ABDOMINAL MRI REVEALED SHE HAD A LOBULATED, SEPTATED CYSTIC MASS IN THE LEFT ADNEXAL REGION THAT WAS NOT SEEN IN PRIOR EXAMS. AN ULTRASOUND ALSO REVEALED THAT THE PATIENT WAS FOUND TO HAVE A COMPLEX ADNEXAL MASS MEASURING 4.5 CM X 3.3 CM WITH CYSTIC AND SOLID COMPONENTS. A DECISION WAS MADE TO PROCEED WITH THE BILATERAL SALPINGO-OOPHORECTOMY. RISKS, BENEFITS AND ALTERNATIVES WERE DISCUSSED WITH THE PATIENT. THE PATIENT ALSO HAD A SIGNIFICANT PULMONARY HISTORY (COPD) AND A BRONCHOSCOPY WAS PERFORMED AT THE BEGINNING OF THE DA VINCI SURGICAL PROCEDURE. AFTER THE DA VINCI ROBOTIC CAMERA WAS INSERTED, DIFFUSE ADHESIONS

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 ADRENELECTOMY 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 TO HER PANCREAS AND DAMAGES THEREFROM.

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 BOWEL INJURY WHILE UNDERGOING A DA VINCI S 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO SUSTAINED A VESSEL INJURY WHILE UNDERGOING A PLANNED DA VINCI-ASSISTED HYSTERECTOMY ON (B)(6) 2012 FOR A SYMPTOMATIC, 15 TO 16-WEEK SIZE FIBROID UTERUS. THE PATIENT SUBSEQUENTLY PASSED AWAY THAT SAME DAY. 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, AT THE BEGINNING OF THE SURGICAL PROCEDURE THE LAPAROSCOPE WAS INTRODUCED AND THE ABDOMEN WAS INSUFFLATED. AT THAT POINT, NO EVIDENCE OF SIGNIFICANT BLEEDING WAS OBSERVED. FOUR TROCARS WERE THEN PLACED WITHOUT DIFFICULTY AND UNDER DIRECT VISUALIZATION WITH THE LAPAROSCOPE. HOWEVER, 1-2 MINUTES AFTER THE LAST TROCAR WAS INSERTED, ANESTHESIA INFORMED THE SURGEON THAT THE PATIENT'S BLOOD PRESSURE HAD COMPLETELY BOTTOMED OUT. THE SURGEON BRIEFLY INSPECTED THE PELVIS AND ABDOMINAL CAVITY AND DID NOT SEE ANY EVIDENCE OF ACTIVE BLEEDING. THE SURGEON SUSPECTED A VASCULAR INJURY AND MADE THE DECISION TO CONVERT TO OPEN SURGERY. THE SURGEON IDENTIFIED

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 BOWEL INJURY WHILE UNDERGOING A DA VINCI S SURGICAL PROCEDURE.

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 BILATERAL SALPINGO OOPHORECTOMY PROCEDURE ON (B)(6) 2012 FOR HIGH GRADE CERVICAL DYSPLASIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED IS LIMITED TO A SINGLE FOLLOW UP NOTE. 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 HEADACHE, ABDOMINAL PAIN, AND VOMITING AND WAS ADMITTED TO A LOCAL HOSPITAL. SHE WAS FOUND TO HAVE SIGNIFICANT BLOOD PRESSURE ELEVATION AND A URINARY TRACT INFECTION. SHE WAS DEHYDRATED AND TESTED POSITIVE FOR OPIATES, MARIJUANA, AND BENZODIAZEPINES. FOR THE EVALUATION OF HEADACHE, A CT SCAN OF THE HEAD WAS PERFORMED AND SHOWED A POSSIBLE MICROANEURYSM OF THE LEFT VERTEBRAL ARTERY.

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 HYSTERECTOMY PROCEDURE, DAMAGE TO THE PATIENT'S BOWEL MAY HAVE OCCURRED. NO OTHER INFORMATION CONCERNING THE REPORTED EVENT HAS BEEN 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 SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012 FOR CHRONIC PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED FOLLOW UP OPERATIVE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. REPORTEDLY, THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE INFORMATION AS PROVIDED IN THE PATIENT'S MEDICAL RECORDS, SHORTLY AFTER UNDERGOING THE PRIMARY SURGERY, THE PATIENT COMPLAINED OF LEAKING URINE. WAS SENT BY HER GYN TO UROLOGIST AND WAS DIAGNOSED VESICOVAGINAL FISTULA. A CYSTOSCOPY CONFIRMED THE DIAGNOSIS. ON (B)(6) 2012 AND (B)(6) 2013 THE PATIENT UNDERWENT REPAIR OF FISTULA WITH VAGINAL APPROACH. THE REPAIRS FAILED AND ON (B)(6) 2013 THE PATIENT UNDERWENT A ABDOMINAL SURGICAL REPAIR OF THE 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: IT WAS REPORTED THAT IN THE (B)(6) 2008, A PATIENT UNDERWENT A DA VINCI S MITRAL VALVE REPAIR PROCEDURE. THE RECOVERY WAS QUICK AND EASY, HOWEVER, THE PATIENT ALLEGES THAT THE MITRAL VALVE REPAIR WAS NOT SUCCESSFUL AND HE STILL HAS A HEART MURMUR AND REGURGITATION OF BLOOD THROUGH THE VALVE.

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, BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD AN ENLARGED FIBROID UTERUS, SEVERE DYSMENORRHEA, EXCESSIVE MENSTRUATION OR MENOMETRORRHAGIA, RIGHT LOWER QUADRANT ABDOMINAL PAIN, CHRONIC LOW BACK PAIN AND VAGINAL PRESSURE. AFTER THE PATIENT'S UTERUS WAS REMOVED DURING THE DA VINCI SURGICAL PROCEDURE, THE SURGEON STATED IN THE OPERATIVE REPORT THAT THE VAGINAL CUFF WAS CLOSED USING 2 V-LOCK SUTURES AND WITHOUT DIFFICULTY. INDIGO CARMINE DYE WAS THEN INJECTED INTO AN IV IN ORDER TO ENSURE THAT THE PATIENT'S GENITOURINARY TRACT WAS INTACT. THERE WAS NO INTRAPERITONEAL SPILLAGE OF INDIGO CARMINE DYE AND THE FOLEY CATHETER WAS TINTED BLUE WITH GOOD URINE OUTPUT AT THE END OF THE PROCEDURE. AT THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS SENT TO THE PACU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY ON (B)(6) 2

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT EXPIRED AFTER UNDERGOING A DA VINCI SI PROSTATECTOMY PROCEDURE.

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 LEFT SALPINGO-OOPHORECTOMY, ABDOMINAL AND PELVIC ADHESIOLYSIS FOR PELVIC PAIN AND A FIBROID UTERUS, MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL ON (B)(6) 2012; DISCHARGE INSTRUCTIONS (B)(6) 2012, WOUND/OSTOMY CONSULT ON (B)(6) 2012, CARE MANAGEMENT CONSULT ON (B)(6) 2012, GENERAL EVALUATION-PHYSICAL THERAPY ON (B)(6) 2012, REHABILITATION MEDICINE CONSULTATION ON (B)(6) 2012, INTERNAL MEDICINE CONSULTATION & CARDIOLOGY CONSULTATION ON (B)(6) 2012, DISCHARGE SUMMARY ON (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. DUE TO THE EXTENSIVE AMOUNT OF ADHESIONS INCLUDING COLON THAT WAS ADHERED TO THE ANTERIOR ABDOMINAL WALL, INITIAL OPEN SUPRAUMBILICAL ACCESS TO THE ABDOMEN FAILED AND ACCESS WAS CREATED IN THE LUQ BY MEANS OF A VISIBLE PORT. IT TOOK AROUND 1.5 HOURS OF ADHESIOLYSIS AND TO DETACH THE SMALL BOWEL AND COLON F

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 DYSMENORRHEA, MENORRHAGIA ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT . ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL NOTES, OPERATIVE REPORTS 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 UNDERWENT ROBOTIC HYSTERECTOMY. FOLLOWING SURGERY, DEVELOPED POSTOP FEVER, ABDOMINAL DISTENTION AND INCREASING FLUID IN THE PELVIS. ON (B)(6) 2012, THE PATIENT RETURNED TO SURGERY- DIAGNOSTIC LAPAROSCOPY CONVERTED TO OPEN LAPAROTOMY WITH SMALL BOWEL RESECTION AND PRIMARY ANASTOMOSIS FOR THROUGH AND THROUGH INJURY. THE SURGEON ALSO FELT THAT A BOWEL INJURY OCCURRED DURING THE ROBOTIC HYSTERECTOMY.

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, USING DUAL SURGEON SIDE CONSOLES (SSC) THE SURGEON WORKING FROM SSC 1 EXPERIENCED RESISTANCE WHILE MANIPULATING THE MASTER TOOL MANIPULATORS (MTM) AND WHEN THE SURGEON LET GO OF THE MTMS ON THE SSC1 THE PATIENT'S ABDOMINAL WALL WAS DAMAGED. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING (TSE) FOR TROUBLE-SHOOTING ASSISTANCE. WITH THE ASSISTANCE OF THE TSE, THE SITE SWITCHED FROM DUAL SSC SETUP TO SINGLE SSC SETUP TO PROCEED WITH THE PLANNED SURGICAL PROCEDURE. RESISTANCE ON THE SSC 2 MTMS WAS NOT EXPERIENCED BY THE SURGEON. THE TSE ASKED THE INITIAL REPORTER IF THE SURGEON WORKING FROM SSC1 HAD REMOVED HEAD FROM THE HIGH RESOLUTION STEREO VIEWER (HRSV) PRIOR TO RELEASING THE HIS HANDS FROM THE MTMS; HOWEVER, THE SURGICAL STAFF WAS UNABLE TO PROVIDE THIS INFORMATION. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND RECOVERABLE SYSTEM ERROR CODE 23002 OCCURRED ON THE MTMR AT THE TIME OF THE CUSTOMER'S REPORT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED.

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 PROCEDURE ON (B)(6) 2012. TYPE OF PROCEDURE WAS NOT PROVIDED. 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, INC. (ISI) RECEIVED INFORMATION AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012, WITH A PRE-OPERATIVE DIAGNOSIS OF MENORRHAGIA, LEIOMYOMATA UTERI AND COMPLEX OVARIAN MASS. ACCORDING TO THE PATIENT'S OPERATIVE (OP REPORT) THERE WERE NO ANOMALIES NOTED. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. REPORTEDLY, AT THE END OF THE SURGICAL PROCEDURE, THE ENTIRE SURGICAL AREA WAS INSPECTED FOR HEMOSTASIS AND THERE WAS NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE PAR IN STABLE CONDITION. REPORTEDLY, DURING HOSPITALIZATION THE PATIENT COMPLAINED OF CHEST PAIN, SHORTNESS OF BREATH AND ABDOMINAL PAIN AND ON (B)(6) 2012. A CHEST CT SCAN SHOWED NO EVIDENCE OF PULMONARY EMBOLISM. ON (B)(6) 2012, THE PATIENT UNDERWENT AN ABDOMINAL AND PELVIS CT SCAN. THE CT SCAN SUGGESTED SUBCUTANEOUS EMPHYSEMA AND PNEUMOPERITONEUM WITH SMALL BO

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 OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND DEVELOPED POST-OPERATIVE COMPLICATIONS. ON (B)(6) 2012, THE PATIENT WAS ADMITTED FOR PERSISTENT DYSFUNCTIONAL UTERINE BLEEDING, PERSISTENT PELVIC PAIN, DYSMENORRHEA AND PROBABLE ADENOMYOSIS. THE PATIENT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE WITH PRESERVATION OF THE OVARIES ON (B)(6) 2012. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WAS NO INDICATION IN THE OPERATIVE REPORTS THAT A MALFUNCTION OCCURRED WITH THE DA VINCI SYSTEM OR INSTRUMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012 IN SATISFACTORY CONDITION. ON (B)(6) 2012, THE PATIENT CONTACTED THE HOSPITAL WITH COMPLAINT OF PASSAGE OF SOME RED TISSUE IN A SMALL CLUMP. SHE HAD NO ACTIVE BLEED AT THAT TIME. SEVERAL HOURS LATER HER BLEEDING WAS HEAVY AND SHE WAS ADVISED TO COME INTO THE ER. SHE WAS TRANSFERRED TO THE HOSPITAL AND UPON ARRIVAL; THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH HYPOTENSION, UNRESPONSIVENESS AND PERSISTENTLY HEAVY VAGINAL BLEEDING. ULTRASOUND WAS PERFORMED AND REVEALED AN 8X6CM CLOT AND FLUID

CyberKnife — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: COMPLICATIONS WERE DESCRIBED IN A ORAL PRESENTATION (B)(6). ACCURAY PREVIOUSLY CONTACTED THE PHYSICIAN AND CONFIRMED THAT THE REPORTED COMPLICATIONS WERE NOT DUE TO A MALFUNCTION OF THE CYBERKNIFE SYS. THE PTS HAD RECEIVED PRIOR RADIOTHERAPY AND WERE UNDERGOING RE-IRRADIATION BY THE CYBERKNIFE SYS IN AN ATTEMPT TO CONTROL RECURRENT DISEASE. DUE TO THE NATURE AND EXTENT OF DISEASE, CYBERKNIFE TREATMENT WAS THE ONLY TREATMENT OPTION FOR THE PTS IN THE STUDY. THE TOXICITIES EXPERIENCED BY THE PTS ARE KNOWN TO BE ASSOCIATED WITH RE-IRRADIATION.

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 ROBOTIC HYSTERECTOMY PROCEDURE FOR UTERINE ENLARGEMENT AND FIBROID TUMORS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE REPORTS AND MEDICAL 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 ABDOMINAL PAIN, NAUSEA, LEFT FLANK PAIN. ADMISSION FOR OBSERVATION. CT SCAN RESULT WAS NORMAL. ON (B)(6) 2012, THE PATIENT VISITED THE ER FOR SIMILAR COMPLAINTS. CT SCAN WAS REPEATED AND SHOWED PELVIC FLUID, AND DILATED URETER. SUSPECT LEFT URETERAL TRANSECTION AND URINOMA. CYSTOSCOPY WITH LEFT RETROGRADE PYELOGRAM SHOWED A DAMAGED TRANSECTED LEFT URETER AS WELL AS AN OPEN BLADDER LACERATION. ON (B)(6) 2012, THE PATIENT WENT FOR URETERAL RE-IMPLANTATION AND BLADDER REPAIR. 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY FOR MENORRHAGIA ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL MEDICAL RECORDS WERE PROVIDED FOR HER POST OPERATIVE CARE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION ON (B)(6) 2009 THE PATIENT DEVELOPED SYMPTOMS OF PNEUMONIA WITH COUGH. SHE REQUIRED HOSPITAL ADMISSION AND ICU TREATMENT. ON (B)(6) 2010 THE PATIENT PRESENTED WITH VAGINAL BLEEDING AND LEAKING FLUID AFTER INTERCOURSE. ON (B)(6) 2010 THE PATIENT UNDERWENT A VAGINAL REPAIR OF PARTIAL VAGINAL CUFF DEHISCENCE USING MULTIPLE SUTURES. NO FISTULA WAS DETECTED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT UNDERWENT A HEMICOLECTOMY PROCEDURE ON (B)(6) 2012 IN WHICH TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI SI SYSTEM WERE USED. AN UNRECOGNIZED BOWEL PERFORATION OCCURRED WHILE PERFORMING TRADITIONAL LAPAROSCOPIC TECHNIQUES DURING ADHESIOLYSIS. THE PATIENT EXPIRED ON (B)(6) 2012.

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 ROBOTICALLY-ASSISTED MINI TVR (TRICUSPID VALVE REPAIR) PROCEDURE VIA RIGHT THORACOTOMY ON (B)(6) 2012. THE LEGAL DOCUMENT PROVIDED CLAIMS THAT AS A RESULT OF THE SURGICAL PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS AND DAMAGES INCLUDING BUT NOT LIMITED TO RESPIRATORY FAILURE AND HD INSTABILITY, PORTAL VEIN THROMBOSIS WITH ELEVATED BILIRUBIN, AND EVENTUALLY, DEATH. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING SURGERY.

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 A DA VINCI PARTIAL NEPHRECTOMY WAS COMPLETED, IT WAS DETERMINED THAT THE PATIENT REQUIRED ANOTHER PROCEDURE. THE PATIENT THEN UNDERWENT AN OPEN PROCEDURE, FOR A TOTAL NEPHRECTOMY. AFTERWARDS, THE PATIENT WAS TRANSFERRED TO (B)(6), WHERE THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE DELAY IN REPORTING IS DUE TO AN ADMINISTRATIVE OVERSIGHT WHERE THE AWARE DATE WAS INADVERTENTLY NOT UPDATED BY A CUSTOMER SERVICE REPRESENTATIVE.

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 SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2012 FOR UTERINE BLEEDING, PELVIC PAIN AND DYSPAREUNIA. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT PRESENTED TO THE EMERGENCY ROOM WITH DIFFUSE ABDOMINAL PAIN, LEUKOPENIA AND ELEVATED LACTIC ACID. A CT SCAN DEMONSTRATED FREE AIR AND FREE FLUID IN THE PELVIS AND RIGHT SIDED HYDRONEPHROSIS. SHE WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE CLOT AND BLEEDING IN HER ABDOMEN, SUTURE MATERIAL AROUND THE AREA WHERE THE URETER WAS OBSTRUCTED BUT NO EVIDENCE OF A THERMAL INJURY TO THE URETER AND BRUISING OF THE COLONIC MESENTERY WITH NO INTESTINAL INJURY. THE UROLOGIST FELT THE URETERAL OBSTRUCTION WAS DUE TO SUTURE MATERIAL FROM THE VAGINAL CUFF OR THE VASCULAR PEDICLE. THE BLEEDING WAS CONTROLLED, A URETEROLYSIS AND STENT PLACEMENT WAS PERFORMED. THE URETERAL STENT WAS REMOVED 6 WEEKS LATER THEN THE PATIENT DEVELOPED A URETERAL-VAGINAL

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 WITH LEFT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT SUSTAINED AN INTRA-OPERATIVE COMPLICATION. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF CHRONIC PERSISTENT PELVIC PAIN AND OVARIAN CYST. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI SI SURGICAL PROCEDURE, THE SURGEON STATED THAT AFTER THE UTERUS WAS REMOVED AND THE VAGINA WAS CLOSED, AN APPROXIMATELY 1.5 CM DEFECT IN THE URINARY BLADDER WAS NOTED WHICH WAS REPAIRED BY A UROGYNECOLOGIST WITH GOOD RESULTS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012, WITHOUT ANY REPORTED ONGOING COMPLICATIONS. NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY WAS REPORTED DURING THE DA VINCI SI SURGICAL PROCEDURE.

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 INJURIES INCLUDING URETER INJURY, URETEROVAGINAL FISTULA, CERVICAL ABSCESSES AND INFECTION. 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 MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS AND OPERATIVE REPORTS OF A PATIENT WHO UNDERWENT A ROBOTIC HYSTERECTOMY PROCEDURE ON (B)(6) 2012. DURING THE ROBOTIC PROCEDURE IT WAS REPORTED THAT THE PATIENT SUSTAINED RIGHT URETERAL INJURY. THE PATIENT'S PRE-OPERATIVE DIAGNOSIS INCLUDED FIBROID UTERUS,MENORRHAGIA AND ANEMIA. ACCORDING TO THE REPORT, A TRANSECTED URETER WAS NOTED DURING THE PROCEDURE. THE ATTENDING UROLOGIST, REIMPLANTED THE URETER INTO THE BLADDER WITH STENT PLACEMENT AFTER UNDOCKING THE DA VINCI SYSTEM. AT THE END OF THE REIMPLANTATION A JACKSON- PRATT DRAIN WAS PLACED IN THE PELVIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN A STABLE CONDITION. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 WITH NO REPORTED ONGOING COMPLICATIONS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PATIENT'S CURRENT STATUS.

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: 'DAMAGE TO URETER (CUT OR BURNED), SURGICAL CORRECTION'.

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: LASER CUT SOMETHING WHICH CAUSE INTESTINES AND OTHER INTERNAL ORGANS TO FALL OUT

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 INJURIES INCLUDING A PERFORATED BOWEL, ABDOMINAL ABSCESSES, SEPTIC SHOCK, AND RESPIRATORY FAILURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2012, THE PATIENT LATER EXPIRED ON (B)(6) 2012. DURING THE SURGICAL PROCEDURE, THE SURGEON DECIDED TO REMOVE THE PATIENT'S GALL BLADDER USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND WITHOUT USING A BAG. AN ISI REPRESENTATIVE IN ATTENDANCE DURING THE SURGICAL PROCEDURE INDICATED THAT NO SYSTEM MALFUNCTIONS OCCURRED DURING THE CASE AND THE PLANNED PROCEDURE WAS COMPLETED WITHOUT ANY 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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON EXPERIENCED NON-INTUITIVE MOVEMENT WITH THE INSTRUMENT AND HAD TO RESEAT THE INSTRUMENT STERILE ADAPTER AND DRAPE. POST-SURGERY, THE PATIENT DEVELOPED AN INFECTION CAUSED BY A HOLE FOUND IN HER BOWEL. AS A RESULT, THE PATIENT'S BOWEL WAS RESECTED.

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 SURGICAL PROCEDURE ON (B)(6) 2012. INTUITIVE SURGICAL WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR MEDICAL RECORDS. THERE WAS NO REPORT THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. PER THE LEGAL DOCUMENT, THE PATIENT SUFFERED A PERFORATED BOWEL AND DIED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THIS EVENT.

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 AND LYMPHADENECTOMY ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES PATHOLOGY REPORT AND OFFICE NOTES. ACCORDING TO THE PATIENT'S OPERATIVE REPORT, DURING THE PRIMARY SURGICAL PROCEDURE, A SMALL RECTOTOMY DISCOVERED WHICH WAS CLOSED AT THE END OF THE SAME PROCEDURE. THIS WAS DISCOVERED DURING DISSECTION OF LEFT SIDE OF PROSTATE GLAND. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PATIENT HAD NO APPARENT POST OPERATIVE COMPLICATIONS AND HE WAS DISCHARGED HOME ON (B)(6) 2012. THE PATIENT'S FOLLOW UP CARE WAS NORMAL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE FOLLOWING PATIENT STORY CONCERNING A DA VINCI SI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2012, AT (B)(6) WAS FOUND POSTED ON THE (B)(6) BY INTUITIVE SURGICAL ON (B)(6) 2012. AFTER TRYING OTHER MEASURES FAILED TO STOP THE BLEEDING AND PAIN OF FIBROIDS A HYSTERECTOMY WAS NECESSARY. THE PROCEDURE WAS SIMPLE AND SCARING AND BLEEDING WERE MINIMAL. THE FIRST 2 WEEKS WENT BY SMOOTHLY AND THE PAIN WAS GONE WITHIN THE FIRST FEW DAYS. THE BIGGEST INCONVENIENCE WAS NOT BEING ABLE TO DRIVE FOR 2 WEEKS. THEN I HAD A TURN FOR THE WORSE. THE DAY AFTER MY 2 WEEK FOLLOW UP APPOINTMENT I STARTED TO BLEED HEAVILY. I WAS SOAKING A PAD AN HOUR. THE ON-CALL SURGEON DID NOT SEEM TO THINK IT WAS SERIOUS AND ADVISED TO WAIT 4 HOURS AND GO TO THE ER IF IT CONTINUED. THE ER DOCTOR DID AND PHYSICAL EXAM AND DID NOT SEE ANY SIGNS OF A RUPTURE. HE TOO CONSULTED THE ON-CALL SURGEON WHO SUGGESTED I BE RELEASED AND TO CONTACT MY DOCTOR THE FOLLOWING MORNING. ON THE WAY HOME FROM THE ER I BEGAN TO EXPERIENCE INTENSE PAIN IN MY LOWER BACK AND CRAMPS EQUIVALENT TO CONTRACTIONS. I FELT A HUGE GUSH OF BLOOD AND FAINTED. THE AMBULANCE WAS CALLED AND I WAS TAKEN BACK TO THE ER BY THIS TIME I HAD BEEN BLEEDING FOR

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 SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6), 2012 DUE TO MENORRHAGIA, PELVIC PAIN AND HYDROSALPINX. ISI WAS PROVIDED WITH THE PATIENT'S PRIMARY OPERATIVE REPORT. ADDITIONAL INFORMATION REGARDING THE PATIENT WAS PROVIDED IN THE PATIENT'S ATTORNEY CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S CLAIM FORM, ON (B)(6), 2012, THE PATIENT EXPERIENCED HEAVY BLEEDING AND WAS HAVING PAIN. THIS OCCURRED AFTER PICKING UP HER (B)(6) CHILD. THE PATIENT WAS INFORMED TO GO TO ER FOR URTGENT CARE EVALUATION. REPORTEDLY, ON (B)(6), 2012 THE PATIENT PRESENTED TO THE ER, COMPLAINING OF PAIN AFTER ENGAGING IN INTERCOURSE THE PREVIOUS NIGHT. THE PATIENT WAS EVALUATED AND IT WAS DISCOVERED THAT THE PATIENT HAD CUFF SEPARATION. SEROSAGINOUS FLUID IN THE VAULT, CUFF DEHISCED. THE PATIENT UNDERWENT A PROCEDURE TO REPAIR HER CUFF. ON (B)(6) 2012, THE PATIENT CONT

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO SUSTAINED AN INJURY TO HER MESENTERIC VEIN PRIOR TO THE START OF A PLANNED DA VINCI SI BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY PROCEDURE ON (B)(6), 2012. ACCORDING TO THE PROCEDURE NOTE, THE INJURY OCCURRED DURING TROCAR PLACEMENT FOR AN EXPLORATORY LAPAROTOMY FOR STAGING OF UTERINE CANCER. THE PATIENT HAD NOT YET BEEN DOCKED TO THE DA VINCI SI SURGICAL SYSTEM AT THE TIME THE INJURY OCCURRED. THE PATIENT'S MEDICAL HISTORY INCLUDED RECENT TOTAL VAGINAL HYSTERECTOMY ((B)(6) 2012) THAT REVEALED STAGE IB ENDOMETRIAL CARCINOMA THAT REQUIRED SURGICAL STAGING. PRIOR TO THE START OF THE PLANNED SURGICAL PROCEDURE, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, PERIOPERATIVE COMPLICATIONS, AND CONVALESCENCE RELATED TO THE PROCEDURE AND SURGICAL CONSENT WAS SIGNED. ACCORDING TO THE OPERATIVE REPORT, AT THE BEGINNING OF THE PLANNED SURGICAL PROCEDURE, A 12 MM TROCAR WAS PLACED SUPRAUMBILICALLY. THE PATIENT WAS NOTED TO HAVE MASSIVE OMENTAL ADHESIONS TO THE PELVIS, SMALL BOWEL, DESCENDING COLON, AND ANTERIOR ABDOMINAL WALL. UPON DIRECT INSERTION

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 AN IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: PATIENT HAD ROBOTIC HYSTERECTOMY, THERE WERE TWO LARGE TEARS IN BOTH RIGHT AND LEFT LATERAL WALLS NEAR THE 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DAVINCI ROBOTIC HYSTERECTOMY 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 REPORTED AN INCIDENTAL CYSTOTOMY DURING THE CREATION OF THE BLADDER FLAP AS AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2012 PATIENT UNDERWENT HYSTERECTOMY WITH BSO AND CYSTOSCOPY WITH REPAIR OF INCIDENTAL CYSTOTOMY. THIS WAS CLOSED BY UROLOGIST DURING PROCEDURE. URETERS WERE IDENTIFIED AND PATENT AT END OF SURGERY, NOTED IN CYSTOSCOPY. DISCHARGED HOME THE NEXT DAY. ON (B)(6) 2012, THE PATIENT RETURN TO HOSPITAL FOR RIGHT URETERAL INJURY, LEAKING URINE FROM VAGINA. CYSTOSCOPY WITH BILATERAL RETROGRADE AND RIGHT URETEROSCOPY WITH STENT PLACEMENT PERFORMED. PATIENT WAS DISCHARGED NEXT DAY. THE PATIENT DID WELL WITH STENT AND RE-IMPLANTATION WAS NOT REQUIRED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI POLYP REMOVAL PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'SURGERY TOOK 5 1/2 HOURS INSTEAD OF 2 DUE TO SCAR TISSUE , HAD TO INTUBATE HIM BECAUSE HE COULD NOT BREATHE, A TEAR IN HIS INTESTINE, DEVELOPED A RASH WHOLE BACK TURNED BACK DOCTORS DID NOTHING, PASSED AWAY FOLLOWING MORNING AUTOPSY SHOWS AN INFECTION.'

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY ON (B)(6) 2012. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT SUSTAINED VAGINAL DEHISCENCE AND PARTIAL EVISCERATION. ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT WAS FOUND TO HAVE ADENOMYOSIS AND COLON ADHESIONS DURING THE SURGICAL PROCEDURE. A POST-OPERATIVE CYSTOSCOPY WAS FOUND TO BE NORMAL. THE LEGAL COMPLAINT ALSO INDICATED THAT THE SURGEON LATER NOTED IN AN OFFICE NOTE THAT SHE HAD TAKEN EXTRA CARE TO TAKE WIDE BITES OF TISSUE WITH CUFF CLOSURE DUE TO PATIENT HISTORY OF HEAVY SMOKING. THE PATIENT WAS REPORTEDLY DISCHARGED HOME IN STABLE CONDITION ON THE FIRST POST-OPERATIVE DAY. THE PATIENT WAS FOUND TO HAVE NO COMPLICATIONS DURING A POST-OPERATIVE FOLLOW-UP VISIT ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS REPORTEDLY ADMITTED TO A HOSPITAL FOR A VAGINAL CUFF DEHISCENCE AND PARTIAL EVISCERATION. THE PATIENT UNDERWENT AN OPEN EXPLORATORY LAPAROTOMY WITH CLOSURE OF THE VAGINAL CUFF. THE INFORMATION RECEIVED STATED THE PATIENT HAS RECOVERED AND APPEARS TO BE DOING WELL. NO ADDITIO

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 S TOTAL HYSTERECTOMY FOR MENORRHAGIA AND FIBROIDS. PROCEDURE DATE IS UNKNOWN. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES MEDICAL RECORDS AND FOLLOW UP OPERATIVE AND PROGRESS REPORTS THERE WAS NOT AN INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY .THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION . LAPAROSCOPIC ROBOTIC HYSTERECTOMY ON (B)(6) 2012. DISCHARGED HOME NEXT DAY IN STABLE CONDITION. ON (B)(6) 2012 VISIT TO UROLOGIST, BEGAN EXPERIENCING RIGHT FLANK AND GROIN PAIN AROUND 2-3 WEEKS POST OP. THEN LEAKAGE IN VAGINA.. ON (B)(6) 2012 CYSTOSCOPY WITH RETROGRADE PYELOGRAM. ATTEMPTED RIGHT URETERAL STENT PLACEMENT. COULD NOT PASS STENT. ON (B)(6) 2012- ROBOTIC RIGHT URETERAL REIMPLANTATION WITH PSOAS HITCH. ON (B)(6) 2012- STENT REMOVAL.

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 PROSTECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION ON (B)(6) 2013 FOR PROSTATE CANCER. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORTS FOR THE PRIMARY SURGERY AND THE EXPLORATORY LAPAROTOMY AND THE DISCHARGE SUMMARY. AFTER STANDARD ENTRY, THE ABDOMEN WAS INSPECTED FOR TROCAR OR VERESS NEEDLE INJURY WITH NO PATHOLOGY OBSERVED. ABUNDANT LOOPS OF SMALL BOWEL WERE FOUND SLIDING INTO THE PELVIS WHICH WERE RETRACTED. THE SURGEON PERFORMED A STANDARD PROSTATECTOMY WITH DISSECTION AND TRANSECTION OF SEMINAL VESICLES AND VAS DEFERENS. IT WAS NOTED THAT DURING THE DISSECTION LOOPS OF BOWEL KEPT SLIDING INTO THE PELVIS REQUIRING REPOSITIONING OF THE PROGRASP TO IMPROVE RETRACTION. THE PELVIC LYMPHNODE DISSECTION WAS COMPLETED TO THE LEVEL OF THE OBTURATOR NERVES. DURING THE LYMPHATIC DISSECTION THERE WAS INDICATION OF AN UNINTENTIONAL SUPERFICIAL CAUTERY INJURY TO THE EXTERNAL ILIAC VEIN BECAUSE OF A CRACK IN THE INSULATION SHEATH OF THE RIGHT ROBOTIC INSTRUMENT WHICH IS INTERPRETED TO BE A MONOPOLAR CURVED SHEARS. THE SHEATH COVER WAS REPLACED, AND THERE WE

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 REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE INFORMATION PROVIDED STATES THAT A FEW WEEKS POST OP, THE PATIENT DEVELOPED SIGNIFICANT URINARY INCONTINENCE. A CT SCAN SHOWED THAT THE PATIENT HAD RIGHT HYDRONEPHROSIS AND HYDROURETER DOWN TO THE PELVIS WITHOUT DISCREET FLUID COLLECTION TO THE VAGINAL WALL. THE FLUID WAS FOUND TO BE CONSISTENT WITH URINE. ON (B)(6) 2012, THE PATIENT UNDERWENT A 2ND DA VINCI SURGICAL PROCEDURE TO REPAIR HER URETER AND A CYSTOSCOPY WITH BILATERAL RETROGRADE PYELOGRAMS. URETERAL STENTS WERE PLACED TO REPAIR THE PATIENT'S URETER. HOWEVER, THE STENT PLACEMENT WAS UNSUCCESSFUL DUE TO URETERAL OBSTRUCTION AND A POSSIBLE URETEROVAGINAL FISTULA. A RIGHT NEPHROSTOMY TUBE WAS THEN PLACED. THE PATIENT TOLERATED THE PROCEDURE WELL AND AFTER COMPLETION OF THE PROCEDURE THE PATIENT WAS EXTUBATED AND TAKEN TO THE POST-ANESTHESIA CARE UNIT FOR ROUTINE POST-SURGICAL CARE. THE PATIENT WAS TRANSFERRED TO THE FLOOR AFTER BEING STABILIZED. THE PATIENT DID WELL POSTOPERATIVELY. THE PATIENT VOIDED SPONTANEOUSLY, HAD ADEQUATE 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 MEDIATION EFFORT ON 08/16/2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S PROCTECTOMY AND OOPHRECTOMY PROCEDURE FOR HER RECTAL CANCER ON (B)(6) 2012. IN THE MEDICAL RECORDS PROVIDED, THERE ARE SEVERAL NOTATIONS BY THE SURGEON THAT THE OPERATIVE RISKS, INCLUDING BLEEDING,ILEOSTOMY, AND INFECTION, WERE DISCUSSED WITH THE PATIENT. PER THE OPERATIVE REPORT, THE SURGERY FIRST COMMENCED LAPAROSCOPICALLY BEFORE THE DA VINCI SI SYSTEM WAS USED. DURING THE INITIAL LAPAROSCOPIC PART OF THE PROCEDURE, THE OPERATIVE REPORT DESCRIBED DISSECTION OF THE STRUCTURES (URETER, OMENTUM, KIDNEY, AND TRANSECTION OF THE INFERIOR MESENTERIC ARTERY AND INFERIOR MESENTERIC VEIN AS WELL AS THE COLON, WHICH WERE CARRIED OUT LAPAROSCOPICALLY WITH THE TAN GIA STAPLER. THE OPERATIVE REPORT DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. LATER THE SAME DAY, THE PATIENT DEVELOPED HYPOTENSION AND RETURNED TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROSCOPY FOLLOWED BY LAPAROTOMY TO CONTROL HER BLEEDING FROM MULTIPLE INTRA-ABDOMINAL BLOOD VESSELS AND CREATION OF ILEOSTOMY.

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 PELVIC LYMPHADENECTOMY FOR STAGE A SQUAMOUS CELL CANCER OF THE CERVIX WITH ADENOPATHY OF THE OMENTUM ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP CARE REPORTS FROM THE HOSPITAL. 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 PRESENTED WITH ABDOMINAL PAIN AND DISTENSION. ON (B)(6) 2012, A CT SCAN WITH CONTRAST OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED MULTIPLE PELVIC FLUID COLLECTIONS CONSISTENT WITH ABSCESSES. THE PATIENT UNDERWENT CT GUIDED DRAINAGE OF A MODERATE-SIZED COLLECTION IN THE RIGHT PARACOLIC SPACE. A CYSTOSCOPY SHOWED A RIGHT URETERAL INJURY WITH LEAKAGE INTO THE PERITONEAL CAVITY. A RIGHT URETER STENT WAS PLACED. ON (B)(6) 2012, THE PATIENT DRAINAGE OF A PELVIC ABSCESS PER THE VAGINA AND REMOVAL OF A PERCUTANEOUS. ON (B)(6) 2013 A RETROGRADE PYELOGRAM REVEALED DAMAGE TO THE DISTAL RIGHT URETER. ON (B)(6) 2013 THE