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 STAGING AND HYSTERECTOMY AND LEFT PARAMETRIAL DISSECTION WITH URETEROLYSIS AND BILATERAL PELVIC LYMPH NODE AND RIGHT PARA-AORTIC NODE DISSECTION ON (B)(6) 2010 FOR ENDOMETRIAL ADENOCARCINOMA. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT FOR THE PRIMARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION PROVIDED INCLUDED THE PATIENT'S HOSPITAL AND RADIOLOGY REPORTS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE PRIMARY SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION ON (B)(6) 2010 THE PATIENT REPORTED FEVER AND WAS READMITTED AND DIAGNOSED WITH PELVIC ABSCESS THOUGHT TO BE AN INFECTED HEMATOMA. ON (B)(6) 2010 THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS, DRAINAGE OF ABSCESS AND EVACUATION OF THE HEMATOMA. A SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS WAS ALSO PERFORMED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON SEPTEMBER 5, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, OMENTAL BIOPSY, AND BILATERAL PELVIC LYMPHADENECTOMY ON (B)(6) 2010. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF BIOPSY-PROVEN GRADE I ENDOMETRIAL CARCINOMA (ENDOMETRIOID TYPE) AND MORBID CENTRAL OBESITY ((B)(6)). DURING A PRE-OPERATIVE CONSULTATION ON (B)(6) 2010, THE PATIENT WAS INFORMED OF THE RISKS, BENEFITS, AND ALTERNATIVES OF LAPAROTOMY VERSUS MINIMALLY INVASIVE TECHNIQUE. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI SURGICAL PROCEDURES ON (B)(6) 2010 WERE COMPLETED WITH ADDED COMPLEXITY DUE TO THE PATIENT'S MORBID CENTRAL OBESITY. DURING THE BILATERAL STAGING PELVIC LYMPHADENECTOMY, DISSECTION WAS CARRIED OUT INFERIORLY TO THE BORDER OF THE OBTURATOR NERVE. THE SURGEON STATED IN THE OPERATIVE NOTE THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY DURING THE PROCEDURES. THE PATIENT WAS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, ABORTED DAVINCI LAPAROSCOPIC SACRAL COLPOPEXY, EXPLORATORY LAPAROTOMY WITH LEFT COMMON ILIAC VEIN REPAIR, ABDOMINAL SACRAL COLPOPEXY, IMPLANTATION OF SYNTHETIC Y MESH, SLING URETHROPEXY AND CYSTOSCOPY FOR UTEROVAGINAL PROLAPSE, URETHRAL HYPERMOBILITY, STRESS INCONTINENCE, INCOMPETENT PUBOCERVICAL FASCIA, INCOMPETENT RECTOVAGINAL FASCIA, ENDOMETRIOSIS, PELVIC CONGESTION SYNDROME, INTRAOPERATIVE LEFT COMMON ILIAC VEIN INJURY, TRIGONITIS, UMBILICAL HERNIA ON (B)(6) 2010. ISI WAS PROVIDED WITH 2 OPERATIVE REPORTS (GYN & VASCULAR). ADDITIONAL INFORMATION PROVIDED INCLUDED: A HANDWRITTEN, LIMITED H & P (B)(6) 2010, A DISCHARGE SUMMARY (B)(6) 2010 AND A ICU CONSULTATION NOTE ON (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS REPORT OF AN INTRAOPERATIVE COMPLICATION (LEFT COMMON ILIAC VEIN INJURY). AFTER A STANDARD ROBOTIC ASSISTED HYSTERECTOMY WAS PERFORMED WITHOUT DIFFICULTIES, FURTHER SEPARATION OF THE PELVIC O

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 PARTIAL SIGMOID COLECTOMY WITH A STAPLED PRIMARY ANASTOMOSIS AND LEFT SALPINGO-OOPHORECTOMY FOR A SIGMOID COLONIC STRICTURE AND LEFT OVARIAN CYST. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. NO ADDITIONAL INFORMATION SUCH AS PAST MEDICAL HISTORY, MEDICATIONS OR SOCIAL HISTORY WAS PROVIDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION. SPECIFICALLY THERE WAS A SEPARATION OF THE COLON AT THE CROTCH OF THE ANASTOMOSIS WHICH WAS SUTURE LIGATED X3. POSTOPERATIVELY THE PATIENT DEVELOPED A FEVER, TACHYCARDIA AND CONFUSION SO ON POSTOPERATIVE DAY 2 ((B)(6) 2010) THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A SUSPECTED ANASTOMOTIC LEAK. SHE WAS FOUND TO HAVE MURKY PELVIC FLUID AND AN EDEMATOUS ANASTOMOSIS BUT NO OBVIOUS LEAK AND NO STOOL/ENTERIC CONTENTS IN THE ABDOMEN/PELVIS. THE PATIENT UNDERWENT A RESECTION OF THE ANASTOMOSIS WITH A NEW HANDSEWN COLO-COLOSTOMY. THE PATIENT INITIALLY DID WELL BUT THEN DEVELOPED A FEV

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE PT COMPLAINED ABOUT INABILITY FOR LONGER EXERCISING DURING A FOLLOW-UP. IN VIEW OF PHYSICIAN, THE PT FOLLOW-UP DATA REVEALED THAT, DURING RECORDED PT EXERCISE EPISODE, THE DEVICE SWITCHED TO AN INADEQUATE PACING MODE.

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 (BSO) ON (B)(6) 2010. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT EXPERIENCED COMPLICATIONS INCLUDING BUT NOT LIMITED TO SEVERE BOWEL INJURIES, EXCESSIVE BLEEDING, INJURY TO THE SIGMOID COLON AND INTESTINES, PLUS POST OPERATIVE COMPLICATIONS AND INFECTION INCLUDING PAIN, BLEEDING, FEVER, CHILLS, NAUSEA AND OTHER SYMPTOMS INDICATIVE OF A BOWEL ISSUE, INFECTION AND COMPLICATIONS AS EARLY AS HER POST-OPERATIVE VISIT ON (B)(6) 2010, WITH A DOCTOR RESULTING IN FURTHER SUFFERING AND COMPLICATIONS TO THE PLAINTIFF INCLUDING BUT NOT LIMITED TO CONSTIPATION, UPPER ABDOMINAL PAIN, VOMITING, AN ABSCESS, A MASSIVE ABDOMINAL INFECTION AND THE NEED FOR FURTHER SURGERY INCLUDING A BOWEL RESECTION ON (B)(6) 2013.

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 LYSIS OF ADHESIONS PROCEDURE ON (B)(6) 2010 FOR MENORRHAGIA AND PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES MEDICAL NOTES AND OPERATIVE REPORTS FROM FOLLOW UP 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. SIGNIFICANT INTRA-ABDOMINAL ADHESIONS WERE ENCOUNTERED. ON (B)(6) 2010, THE PATIENT PRESENTED WITH COMPLAINTS OF URINARY LEAKING. VARIOUS STUDIES CONFIRMED THE PRESENCE OF A RIGHT URETEROVAGINAL FISTULA WITHOUT EVIDENCE OF HYDRONEPHROSIS. ON (B)(6) 2010, THE PATIENT DEVELOPED A RIGHT PYELONEPHRITIS WITH CULTURE POSITIVE FOR ENTEROCOCCUS. ON (B)(6) 2010, THE PATIENT UNDERWENT A RIGHT URETERONEOCYSTOTOMY WITH URETERAL RE-IMPLANTATION. FOLLOW UP CYSTOSCOPY WITH REMOVAL OF STENT WAS CONSIDERED NORMAL WITH NORMAL RIGHT URETERAL FUNCTION.

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 THE ROBOTIC PORTION OF A COLON RESECTION WAS SUCCESSFULLY PERFORMED, THE PATIENT SUFFERED A HEART ATTACK WHILE THE SURGEONS WERE CLOSING THE PATIENT USING STANDARD MEDICAL PROCEDURE. THE PATIENT WAS UNABLE TO BE RESUSCITATED AND EXPIRED ON THE TABLE.

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 PROSTATECTOMY PROCEDURE, WHEN THE SURGEON ACTIVATED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT, SLIGHT ENERGY ACTIVATION COULD BE SEEN AT THE MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENT TIPS RESULTING IN A SUPERFICIAL BURN TO THE PATIENT'S PELVIC FASCIA. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER (TSE), THE SITE EXCHANGED THE INSTRUMENT ENERGY CORDS, CHECKED THE PATIENT GROUNDING PAD AND EXCHANGED THE MCS INSTRUMENT FOR ANOTHER INSTRUMENT OF THE SAME TYPE, HOWEVER, THE ISSUE CONTINUED TO OCCUR. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO FURTHER PATIENT HARM WAS REPORTED. ADDITIONALLY, THE PATIENT DID NOT REQUIRE SURGICAL REPAIR DUE TO THE SUPERFICIAL BURN.

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 TOTAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010 FOR PELVIC PAIN AND MULTIPLE UTERINE LEIOMYOMA. 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. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION DURING THE PROCEDURE ON (B)(6) 2010 TO REMOVE THIS 274G UTERUS WITH MULTIPLE SUBSEROSAL FIBROIDS. THE UTERINE AND OVARIAN VASCULATURE WERE TRANSECTED IN A STANDARD FASHION. AFTER DISCONNECTION OF THE UTERUS PNEUMOPERITONEUM WAS TEMPORARILY LOST. GOOD CLOSURE OF THE VAGINAL CUFF OCCURRED WITH NO BLEEDING. ESTIMATED BLOOD LOSS WAS 100ML. THE PATIENT WAS AWOKEN AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2010, THE PATIENT PRESENTED WITH MILD ILEUS AND A PARTIAL LEFT URETERAL OBSTRUCTION WITH EXTRAVASATION OF URINE INTO THE ABDOMEN. A CT SCAN SHOWED EXTRAVASATION OF URINE INTO THE ABDOMINAL CAVITY ON (B)(6) 2010. ON (B)(6) 2010, A LEFT URETERAL STENT WAS EASILY PLACED. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. SHE WAS TREATED FOR URETERAL STRICT

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 PT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B) (6), 2010, PASSED AWAY ON (B) (6), 2010. THE ATTENDING SURGEON INDICATED THAT THE SURGICAL PROCEDURE WENT WELL AND THERE WERE NO SYS MALFUNCTIONS. POSTOPERATIVELY, THE PT'S ABDOMINAL PAIN WAS MINIMAL AND HER VITAL SIGNS WERE STABLE, HOWEVER, SHE HAD A SEVERE MIGRAINE HEADACHE THE MORNING OF HER DISCHARGE. THE PT DECLINED MEDICATION FOR HER HEADACHE AND WAS DISCHARGED ON (B) (6), 2010. LATER THAT EVENING, THE PT COMPLAINED OF FATIGUE AND BECAME UNCONSCIOUS. THE PT EXPIRED THE FOLLOWING DAY. ON (B) (6), 2010, THE SURGEON ALSO INDICATED THAT THE AUTOPSY WAS NOT YET COMPLETE AND ISI WILL BE FORWARDED A COPY OF THE AUTOPSY REPORT WHEN IT BECOMES AVAILABLE.

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 LEGAL SUMMONS INDICATING THAT POST OP A DA VINCI SI LYSIS OF ADHESIONS WITH LEFT OVARIAN ENDOMETRIOMA ASPIRATION PROCEDURE PERFORMED ON (B)(6) 2010 AT (B)(6), IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A BOWEL INJURY. REPORTEDLY, POST-OPERATIVELY, THE PATIENT EXPERIENCED SYMPTOMS COMPATIBLE WITH A BOWEL INJURY AND AS A RESULT THE PATIENT WAS HOSPITALIZED UNTIL (B)(6) 2010. THE LEGAL SUMMONS INDICATED THAT ON (B)(6) 2010, THE PATIENT WAS ADMITTED INTO THE EMERGENCY ROOM AT (B)(6) WITH PERITONEAL SIGNS. REPORTEDLY, THE PATIENT HAD TO BE RESUSCITATED AND A CT SCAN PERFORMED FOUND THAT THE PATIENT HAD DEVELOPED MASSIVE PNEUMOPERITONEUM WITH A MASSIVE AMOUNT OF FREE FLUID. REPORTEDLY, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY WITH RESECTION AND ANASTOMOSIS OF THE DISTAL ILEUM AND A WASHOUT OF THE PERITONEAL CONTAMINATION. REPORTEDLY, THE PATIENT HAS CONTINUED TO EXPERIENCE COMPLICATIONS AS A RESULT OF THE BOWEL INJURY AND 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: UROLOGIST CALLED TO REPORT PROBLEMS WITH ROBOTIC EQUIPMENT. THE UROLOGIST HAD TO CONVERT THE ROBOTIC PROSTATECTOMY CASE TO OPEN WHEN THE SYSTEM STOPPED WORKING. THE NEXT WEEK, THE SURGEON HAD TWO ROBOTIC PROSTATECTOMIES. DURING THE FIRST CASE THERE WERE 10 ALARMS WITH THE ERROR #20013, THAT SAID PRESS FAULT OVERRIDE BUTTON. DESPITE THIS PROBLEM THE FIRST CASE WENT AS PLANNED WITHOUT ANY OTHER ISSUES. DURING THE SECOND CASE THE SAME PROBLEM WITH THE FAULT ALARM OCCURRED THREE TIMES; ON THE THIRD TIME THE FAULT DID NOT OVERRIDE. THE MANUFACTURER WAS CONTACTED USING THE DAVINCI HELP NUMBER. WE WERE INSTRUCTED TO UNDOCK THE ROBOT COMPLETELY AND POWER DOWN. I WAS INSTRUCTED TO CHECK SOME CONNECTIONS ON THE CONSOLE, WHICH WERE FINE. THEN WE TURNED ON THE ROBOT AND STARTED AGAIN. WE HAD ANOTHER FAULT THAT WE COULD NOT OVERRIDE, SO I CALLED THE COMPANY AGAIN, HAD THE SURGEON PRESS THE EMERGENCY STOP BUTTON AND THEN FAULT OVERRIDE. THIS WAS TO RELEASE THE INSTRUMENTS' GRASPS ON THE TISSUE. AT THAT TIME THERE WAS A BLEEDER THAT HADN'T FULLY GOTTEN UNDER CONTROL BECAUSE THE ROBOT WAS FROZEN. THERE WERE THREE MORE FAULTS BEFORE WE HAD ANOTHER IRRECOVERABLE FAULT. THE SURGEON DECIDED TO COMPLET

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 OVARIAN CYST ON (B)(6) 2009. 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) 2009, THE PATIENT UNDERWENT ROBOTIC HYSTERECTOMY WITH BSO. ON (B)(6) 2009, PATIENT WENT FOR A FOLLOW-UP VISIT WITH OB/GYN NOTES OF NOT DOING WELL. SEVERAL ER VISITS FOR PAIN AND DISCHARGE. THE PATIENT IS ON ANTIBIOTICS. ON (B)(6) 2009, PATIENT WAS PRESENTED TO ER WITH COMPLAINTS OF PAIN, BLEEDING AND BLOOD IN URINE- FOLLOWING INTERCOURSE. PATIENT HAD A FULL VAGINAL CUFF DEHISCENCE REPAIR WITH BOWEL PROTRUDING INTO THE UPPER PORTION OF VAGINA. VAGINAL AND LAPAROSCOPIC APPROACH FOR REPAIR. THE PATIENT WAS DISCHARGED HOME NEXT DAY. ON (B)(6) 2010 SUBSEQUENT SECOND DEHISCENCE FOLLOWING INTERCOURSE, UNDERWENT LAPAROTOMY WITH EXCISION OF SUPERIOR VAGINAL CUFF AND RECLOSURE. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING SYSTEM SETUP FOR A DA VINCI SI SURGICAL PROCEDURE, A HOSPITAL EMPLOYEE FELT A LITTLE SHOCK WHEN ASSISTING WITH DRAPING OF THE CAMERA. THE HOSPITAL EMPLOYEE HAD THE CAMERA HEAD IN HER RIGHT HAND AND THE SHOCK OCCURRED WHEN SHE GRABBED THE CAMERA CABLE AND THE SILVER HANDLES ON THE CAMERA WITH HER LEFT HAND. NO ADDITIONAL HARM WAS REPORTED.

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 PARTIAL NEPHRECTOMY FOR L RENAL MASS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES SUBSEQUENT OPERATIVE 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 . POSTOPERATIVELY, THE PATIENT DEVELOPED OLIGURIA, ELEVATIONS IN CREATININE, AND FEVER. ON VENTILATOR FOR AN EXTENDED PERIOD OF TIME. ACUTE RENAL FAILURE ENSUED. RADIOLOGY CONSULTATION NOTES COLON PERFORATION SECONDARY TO ROBOTIC INTERVENTION. ALSO NOTED BY PATHOLOGY. ON (B)(6) 2010- EXPLORATORY LAPAROTOMY, LEFT COLECTOMY WITH END TRANSVERSE COLOSTOMY. ABDOMINAL WASHOUT FOR PERITONITIS. ON (B)(6) 2010 -CYSTOSCOPY WITH LEFT RETROGRADE PYELOGRAM AND DOUBLE J STENT PLACEMENT FOR A SMALL HOLE IN URETER DISCOVERED AT TIME OF BOWEL SURGERY. HAD TWO ROBOTIC INJURIES. DISCHARGED HOME ON (B)(6) 2010 AFTER A ONE MONTH ADMISSION. HOWEVER, NOT TO HOME- WAS SENT TO SKILLED NURSING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE WAS PERFORMED, THE PATIENT HAD A REDDENED AREA ON THEIR LEFT SHOULDER WHERE THE SHOULDER PADS WERE USED. THE PATIENT WAS ALSO COMPLAINING OF INTENSE SHOULDER PAIN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION, INCLUDING MEDICAL RECORDS, OF A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. ON (B)(6) 2010, APPROXIMATELY 1 WEEK BEFORE THE HYSTERECTOMY PROCEDURE, THE PATIENT UNDERWENT A LOOP ELECTROSURGICAL EXCISION PROCEDURE (LEEP) AND ENDOCERVICAL CURETTAGE TO EVALUATE A HIGH-GRADE DYSPLASIA WITH FINDINGS OF SMALL FOCUS OF MICROINVASIVE SQUAMOUS CELL CARCINOMA OF THE CERVIX. ON (B)(6) 2010, THE PATIENT UNDERWENT THE DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO OOPHORECTOMY. ACCORDING TO THE OPERATIVE REPORT, THE NEOVASCULARIZATION AND HYPERTROPHY OF SMALL VESSELS WERE NOTED WITH INCREASED OOZING OF BLOOD, WHICH WAS CONTROLLED WITH CAUTERY AND CLOSURE OF THE VAGINAL CUFF. THE VAGINAL CUFF WAS CLOSED BY TAKING GENEROUS BITES BACK FROM THE DIVIDED EDGES OF THE VAGINA AS THE PATIENT WAS AT INCREASED RISK OF POOR WOUND HEALING AND SEROMA FORMATION, AS WELL AS POSTOPERATIVE HEMATOMA FORMATION. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION; NO COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THE OPERATIVE REPORTS DID NO

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 NOTICED A BURN MARK ON THE PATIENT'S ABDOMEN, LOCATED AT ONE OF THE PORT INCISIONS WHERE A CANNULA ACCESSORY WAS USED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO ADDITIONAL PATIENT HARM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY FOR REFRACTORY MENORRHAGIA ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS. IN ADDITION, A PATHOLOGY REPORT WAS 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. THE PROCEDURE WAS UNEVENTFUL - OVARIES WERE LEFT IN PLACE PER PATIENT'S WISHES. THE UTERUS WEIGHED 134 GRAMS. SHE WAS MOVED TO THE POST-ANESTHESIA CARE UNIT IN GOOD CONDITION. ESTIMATED BLOOD LOSS WAS 450ML. SHE WAS DISCHARGED HOME ON (B)(6) 2010 FOR A TOTAL STAY OF ONE DAY. ON (B)(6) 2010 THE PATIENT PRESENTED WITH NAUSEA, VOMITING AND ABDOMINAL PAIN. SHE REPORTED A BROWNISH RED VAGINAL DISCHARGE. A DIAGNOSIS OF POSTOP ILEUS WAS MADE. A CT SCAN WAS CONDUCTED ON (B)(6) 2010 AND NOTED ATELECTASIS IN BOTH LOWER LUNG FIELDS. A PULMONARY THROMBOEMBOLISM WAS NOT NOTED, BUT POSSIBLE EARLY INFILTRATES WERE NOTICED IN THE RIGHT BASE COULD BE EARLY PNEUMONIA. KIDNEYS WERE NOTED AS NORMAL. A LATER PYELOGRAM NOTED LEFT HYDRONEPHROSIS AND A DILATED

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 AFIB PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'DEATH'.

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 POST A DA VINCI SI THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS DUE TO RADIAL NERVE DAMAGE.

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 BILATERAL SALPINGO-OOPHORECTOMY FOR A PELVIC MASS, AN ENLARGED UTERUS, ATYPICAL CELLS ON ENDOMETRIAL BIOPSY, AND UNSATISFACTORY ENDOMETRIAL BIOPSY PLUS UTERINE FIBROIDS ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: DISCHARGE SUMMARY FROM (B)(6) 2010, SURGICAL PATHOLOGY REPORT (B)(6) 2010, HISTORY AND PHYSICAL (H&P) (B)(6) 2010, OR REPORT (B)(6) 2010 AND THE ATTORNEYS CLAIM FORM. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. AFTER PLACEMENT OF THE UTERINE MANIPULATOR AND DEVELOPMENT OF A PNEUMOPERITONEUM THROUGH AN OPEN INCISION IN THE LUQ, ALL PORTS WERE PLACED UNDER DIRECT VISUALIZATION. THEN, THE ROUND LIGAMENTS WERE BILATERALLY SEALED AND DIVIDED, THE BLADDER FLAP DEVELOPED USING SHARP DISSECTION, BOTH URETERS IDENTIFIED AND THE INFUNDIBULOPELVIC LIGAMENTS SEALED AND DIVIDED. COLPOTOMY WAS PERFORMED CIRCUMFERENTIALLY ONTO THE UTERINE MANIPULATOR CUP AND THE

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PT WHO UNDERWENT A DA VINCI S TORS PROCEDURE ON (B) (6), 2010, EXPIRED ON (B) (6), 2010. ON MAY 4, 2010, THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE INFORMED ISI THAT THERE WERE NO ACUTE COMPLICATIONS WITH THE CASE AND THE PT WAS DISCHARGED 4-5 DAYS AFTER THE PROCEDURE WAS PERFORMED. THE SURGEON ALSO MENTIONED THAT FOLLOW-UP WAS CONDUCTED WITH THE PT APPROX ONE WEEK AFTER THE OPERATION AND THE PT WAS FOUND TO BE DOING WELL. SHORTLY AFTER, THE PT BEGAN EXPERIENCING POST-OPERATIVE BLEEDING AND PASSED AWAY. THE SURGEON INDICATED THAT HE DOES NOT BELIEVE THAT THE ROBOTIC PROCEDURE WAS THE DIRECT CAUSE OF THIS UNFORTUNATE EVENT, BUT RATHER THIS IS THE TYPE OF COMPLICATION THAT IT ASSOCIATED WITH THESE TYPE OF SURGICAL PROCEDURES. ON MAY 20, 2010, THE SURGEON INDICATED THAT THEY DO NOT HAVE ACCESS TO THE PT'S DEATH CERTIFICATE OR THE HOSPITAL RECORDS FROM THE INSTITUTION THAT THE PT WAS TAKEN TO ON (B) (6), 2010. ADDITIONALLY, THE PT'S FAMILY INFORMED THE SURGEON VIA TELEPHONE THAT THEY DID NOT SEEK AN AUTOPSY.

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 MENORRHAGIA AND ENDOMETRIOSIS PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDE HOSPITAL NOTES, OFFICE NOTES, RADIOLOGY 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) 2010 THE PATIENT WAS ADMITTED FOR ROBOTIC TOTAL HYSTERECTOMY. THE PATIENT WAS DISCHARGED HOME THE NEXT DAY IN STABLE CONDITION. ON (B)(6) 2010, THE PATIENT WAS RE-ADMITTED FOR VAGINAL CUFF DEHISCENCE AND UNDERWENT SURGICAL REPAIR VIA A VAGINAL APPROACH. THIS PATIENT HAD A VERY SMALL CUFF PELVIC HEMATOMA AND RESULTANT CUFF SEPARATION WITHOUT EVISCERATION, INFECTION OR COMPLICATION.

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 POST A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS IN HER HANDS AND FINGERS AND SHARP PAIN AND TINGLING IN HER LEGS. PER THE SURGEON THAT PERFORMED THE OPERATION, THE MYOMECTOMY PROCEDURE TOOK LONGER THAN ANTICIPATED, APPROXIMATELY 5 HOURS, WITH THE PATIENT IN THE TRENDELENBURG POSITION. PER THE OPERATIVE REPORT THE PATIENT TOLERATED THE ENTIRE PROCEDURE WELL WITH GOOD HEMOSTASIS AND MINIMAL BLOOD LOSS.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST A DA VINCI S COX CRYO-MAZE ATRIAL FIBRILLATION PROCEDURE, THE PATIENT SUFFERED FROM HEPATORENAL FAILURE AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC). IT WAS REPORTED THAT THE PATIENT EXPIRED TWO DAYS AFTER THE PROCEDURE. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI PROSTATECTOMY PROCEDURE, WHILE THE SURGEON WAS PERFORMING A DISSECTION, THE MONOPOLAR FOOT PETAL WAS PRESSED, HOWEVER, THE BIPOLAR ENERGY BECAME ACTIVATED. THE BIPOLAR INSTRUMENT WAS HOLDING TISSUE AND CREATED A SUPERFICIAL LACERATION TYPE BURN TO THE PATIENT'S BOWEL. A GENERAL SURGEON REVIEWED THE INJURY AND DETERMINED THAT THE BURN WAS NOT THROUGH AND THROUGH AND DID NOT REQUIRE REPAIR, HOWEVER, THE SURGEON PLACED ONE SUTURE IN THE PATIENT'S BOWEL AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE SAME EQUIPMENT AND NO FURTHER INSTANCES OF THE EVENT WAS REPORTED.

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 HAD UNDERWENT A DA VINCI HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, PLICATION OF THE UTEROSACRAL LIGAMENT AND LYSIS OF ADHESIONS FOR THE INDICATION OF FIBROID UTERUS AND MENOMETRORRHAGIA PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY AND FOLLOW UP SURGERY AND OFFICE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE PATIENT'S UTERUS WAS NOTED TO BE LARGE AND DEFORMED WITH SEVERAL FIBROIDS, AND AN ADHESION OF THE LEFT OVARY TO THE PELVIC SIDEWALL WITH A CLEAR FLUID CYST. THE STANDARD PROCEDURE WAS PERFORMED WITH ISOLATION, CAUTERIZATION AND CUTTING OF THE LATERAL LIGAMENTS AND UTERINE ARTERIES BILATERALLY. THE RIGHT SIDE WAS NOTED TO BE ADHERED TO THE RIGHT ABDOMINAL WALL MAKING ACCESS TO THE IP LIGAMENT DIFFICULT. THE VAGINAL INCISION WAS MADE AROUND A VCARE AND THE UTERUS DELIVERED VAGINALLY. THE VAGINAL CUFF WAS CLOSED WITH 0 VICRYL, THE UTEROSACRAL LIGAMENT PLICATED. NO COMPLICATIONS WERE NOTED DURING THE SURGERY. ON (B)(6), THE PATIENT PRESENTED WITH A HIS

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON JULY 25, 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2010. NO INTRA-OPERATIVE COMPLICATIONS WERE DOCUMENTED IN THE OPERATIVE REPORT. AFTER THE PATIENT'S UTERUS WAS RESECTED AND MORCELLATED, HER PELVIS WAS IRRIGATED. THE OPERATIVE REPORT STATED THAT EXCELLENT HEMOSTASIS WAS NOTED. UPON CONCLUSION OF THE SURGICAL PROCEDURE, THE PATIENT'S SKIN INCISIONS WERE CLOSED. SHE WAS THEN EXTUBATED AND ESCORTED TO RECOVERY IN EXCELLENT CONDITION. BASED ON THE PATIENT'S MEDICAL RECORDS, THE PATIENT EXPERIENCED VAGINITIS AND VAGINAL INFECTIONS ON MULTIPLE OCCASIONS BETWEEN (B)(6) 2010 AND (B)(6), 2012. ON (B)(6) 2012, THE PATIENT HAD AN OFFICE VISIT AND WAS EVALUATED FOR HYDRONEPHROSIS. THE OFFICE VISIT REPORT STATED THAT THE PATIENT HAD AN MRI THAT REVEALED LEFT SIDED HYDRONEPHROSIS. IT IS UNKNOWN WHAT DATE THE MRI WAS PERFORMED. THE OPERATIVE REPORT ALSO STATED THAT THE PATIENT HAS BEEN TOLD THAT SHE HAS HAD HYDRONEPHROSIS IN THE PAST. ON (B)(6) 2012, A CT SCAN WAS PERFORMED ON THE PATIENT'S ABDOMEN AND PELVIS. THE CT SCAN

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 MAY 4, 2010, A WALL STREET JOURNAL (WSJ) ARTICLE TITLED "SURGICAL ROBOT EXAMINED IN INJURIES" WAS PUBLISHED. THE ARTICLE INCLUDED DETAILS CONCERNING PT INJURIES AND A PT DEATH AT (B) (6) HOSPITAL. NONE OF THE ALLEGATIONS OF PT INJURIES IN THE WSJ ARTICLE WERE REPORTED TO ISI, HOWEVER, ON (B) (6) 2010, UPON FOLLOW UP WITH THE HOSPITAL, (B) (6), THE VP OF COMMUNITY RELATIONS, CONFIRMED ONE PT INJURY. REPORTEDLY, AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE PT DID NOT HAVE URINE OUTPUT. ON (B) (6) 2009, A CYSTOSCOPY WITH URETEROSCOPY AND EXPLORATORY LAPAROSCOPY PROCEDURE WAS PERFORMED WHICH REVEALED THAT THE PT HAD BILATERAL URETERAL TRANSECTION. BILATERAL URETERAL REIMPLANTATIONS AND A BILATERAL URETERAL STENT PLACEMENT WAS REQUIRED TO REPAIR THE AFFECTED AREA. IN ADDITION, (B) (6) STATED THAT (B) (6) HAS NO RECORD OF THE OTHER PT INJURIES/PT DEATH RELATED TO THE DA VINCI S SURGICAL SYSTEM AS INDICATED IN THE WSJ ARTICLE. DAMAGE TO THE PT'S URETER PROLONGED THE PT'S HOSPITALIZATION AND THE PT HAS RETURNED TO THE HOSPITAL DUE TO POST OPERATIVE COMPLICATIONS. THE HOSPITAL WAS UNABLE TO PROVIDE ADDITIONAL INFO CONCERNING THE PT'S 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 MEDIATION EFFORT, ON (B)(4) 2013 INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION CONCERNING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE INFORMATION RECEIVED STATES THAT THE PATIENT SUSTAINED A THERMAL MONOPOLAR INJURY TO HER URETER DURING THE SURGICAL PROCEDURE WHICH CAUSED DOCUMENTED EXTRAVASATION OF URINE INTO THE PERITONEAL CAVITY AND THAT THIS WAS DIRECTLY CAUSATIVE TO THE FLUID COLLECTION AND INCREASED PELVIC PAIN THAT WAS THEN MISDIAGNOSED AS AN OVARIAN CYST. THE INFORMATION STATES THAT THE PATIENT UNDERWENT SURGICAL CASTRATION AS A DIRECT RESULT OF A COMPLICATION FROM HER DA VINCI HYSTERECTOMY. THE DOCUMENTATION STATES THAT AT THE TIME OF THE SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE A SMALL UTERUS, NORMAL OVARIES BILATERALLY, AND NO EVIDENCE OF EXTRA-CERVICAL DISEASE. DURING POST OPERATIVE FOLLOW UP THE PATIENT EXPERIENCED SHOULDER PAIN AND RECEIVED PHYSICAL THERAPY FOR A DIAGNOSIS OF COMPRESSION FROM SURGICAL POSITIONING. THE PATIENT RECEIVED NON STEROID ANTI-INFLAMMATORY TREATMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2010, THE DOCUMENTATION STATES THAT THE PATIENT RETURNED T

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2012, INTUITIVE SURGICAL RECEIVED A LEGAL SUMMONS INDICATING THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012, WHILE THE SURGEON WAS PERFORMING NODE DISSECTION, THE SURGEON CUT THE PATIENT'S ILIAC ARTERY AND VEIN CAUSING BLEEDING FROM THOSE VESSELS. A HEMO-CLIP WAS APPLIED TO THE AFFECTED AREA, HOWEVER, THE CLIP TORE THROUGH THE AREA WHERE THE CLIP WAS APPLIED CAUSING SIGNIFICANT HEMORRHAGE FROM THE PELVIC VESSELS. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED SURGICAL PROCEDURE TO OPEN LAPAROTOMY TECHNIQUES. THE PATIENT EXPIRED ON (B)(6) 2012.

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, ADHESIOLYSIS, AND REPAIR OF VAGINAL WALL LACERATION PROCEDURE ON (B)(4) 2010 FOR AN ENLARGED FIBROID UTERUS, ANEMIA, PERSISTENT OVARIAN CYST, AND CHRONIC PELVIC PAIN. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES AN UNDATED OPERATIVE REPORT OF A FISTULA REPAIR, A PATHOLOGY REPORT FROM (B)(6) 2010, AND OFFICE NOTES FROM THE PRIMARY SURGEON DOCUMENTING THE PATIENT'S RECOVERY ON (B)(6) 2010. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. ACCORDING TO THE DA VINCI SURGICAL PROCEDURE OPERATIVE REPORT, THE PATIENT WAS NOTED TO HAVE A UTERUS THAT WAS ENLARGED, IRREGULAR, FIRM CONSISTENCY, AND HAD FIBROIDS. BOWEL ADHESIONS TO ANTERIOR ABDOMINAL WALL ON RIGHT WERE NOT IN DIRECT FIELD OF OPERATION; THEY WERE MORE LATERAL. ADHESIONS ON LEFT SIDE WERE LYSED TO GET BOWEL AWAY FROM INFUNDIBULOPELVIC LIGAMENTS. ON CONTRALATERAL SIDE, THE SURGEON LOOKED TO SEE IF MORE ROOM TO MANEUVER THE BULKY UTERUS AND NOTED IT WAS 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 ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY, COLLECTION OF PERITONEAL CYTOLOGY AND PELVIC LYMPHADENECTOMY ON (B)(6) 2010. THE PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF GRADE 2 ENDOMETRIAL CARCINOMA. ACCORDING TO THE PATIENT'S OPERATIVE (OP REPORT) THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. REPORTEDLY, AT THE END OF THE SURGICAL PROCEDURE, EXCELLENT HEMOSTASIS WAS NOTED AFTER CLOSURE OF THE PATIENT'S VAGINAL CUFF WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS EXPERIENCED BY THE PATIENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. REPORTEDLY DURING A POST-OPERATIVE EXAMINATION ON (B)(6) 2010, IT WAS DISCOVERED THAT THE PATIENT HAD A SLIGHT VAGINAL CUFF DEHISCENCE AT THE APEX AND ON THE SAME DAY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR THE AFFECTED AREA.

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), 2010. 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 URINARY INCONTINENCE AND ERECTILE DYSFUNCTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI'S PARTIAL NEPHRECTOMY PROCEDURE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE PATIENT'S PRIMARY OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDED THE HOSPITAL CONSULTATION AND OPERATIVE NOTES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT EXPERIENCED PERSISTENT PAIN POST OPERATIVELY AND WAS FOUND TO HAVE A POSSIBLE SMALL BOWEL PERFORATION. ON (B)(6) 2010, AN EXPLORATORY LAPAROTOMY WAS PERFORMED WITH LYSIS OF ADHESIONS AND A SMALL BOWEL RESECTION. HE ALSO DEVELOPED A DEEP VEIN THROMBOSIS WITH PULMONARY EMBOLI AND DEVELOPED SOME EXTRAVASATION FROM THE OPERATIVE AREA OF HIS LEFT KIDNEY. HE ALSO DEVELOPED SOME PROBLEMS WITH ATRIAL FIBRILLATION. ACCORDING TO THE PATIENT'S DISCHARGE SUMMARY REPORT, DURING THE PATIENT'S PRIMARY SURGICAL PROCEDURE, THE OPERATION INVOLVED A FAIR AMOUNT OF LYSIS OF ADHESION IN ORDER TO GET THE TROCARS IN.

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 LAPAROSCOPIC SUBTOTAL COLECTOMY WITH ILEOSIGMOID ANASTOMOSIS WITH DA VINCI-ASSISTED MOBILIZATION OF THE DISTAL SIGMOID DUE TO UNRESECTABLE, PREMALIGNANT TRANSVERSE COLON POLYPS AND CHRONIC CONSTIPATION ON (B)(6) 2010. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND THE PATIENT'S MEDICAL RECORDS. THE OPERATIVE REPORT DOES NOT CONTAIN ANY ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. PER THE OPERATIVE REPORT, AFTER TROCAR PLACEMENT WAS PERFORMED, THE SURGEON NOTED THAT THE ROBOT WAS NOT AVAILABLE FOR USE. ONCE THE ENTIRE SMALL BOWEL, CECUM, HEPATIC, TRANSVERSE, SPLENIC, AND DESCENDING COLON WERE MOBILIZED LAPAROSCOPICALLY, THE ROBOT WAS DOCKED FROM THE LEFT SIDE AND THE REST OF THE SIGMOID WAS MOBILIZED DOWN TO THE LEVEL OF THE PELVIC BRIM. THE SURGEON NOTED THAT THE LEFT URETER WAS IDENTIFIED AND KEPT OUT OF HARMS WAY. THE ROBOT WAS THEN UNDOCKED. THE SURGEON NOTED THE TOTAL ROBOT TIME WAS LESS THAN 10 MINUTES. THE PROCEDURE CONTINUED WITH DISSECTION OF THE COLON AND ANTIMESENTERIC SIDE-TO-SIDE FUNCTIONAL END-TO-END ANASTOMOSIS.

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 PELVIC AND PARA-AORTIC LYMPH NODE SAMPLING, URETEROLYSIS, AND CYSTOSCOPY WITH STENT PLACEMENT ON (B)(6) 2010. THE PATIENT WAS DIAGNOSED WITH STAGE IB-1 CERVICAL ADENOSQUAMOUS CARCINOMA. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HISTORY AND PHYSICAL EXAM, PATHOLOGY REPORTS, DISCHARGE SUMMARY, SUBSEQUENT OPERATIVE NOTES FROM UROLOGY, UROLOGY CONSULTATIONS AND HOSPITAL DISCHARGE SUMMARIES. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ACCORDING TO THE INFORMATION PROVIDED, ON (B)(6) 2010, THE PATIENT PRESENTED WITH LOWER ABDOMINAL PAIN AND WAS ADMITTED FOR EVALUATION AND WAS FOUND TO HAVE A LEFT URETERAL INJURY. A PERITONEAL FLUID COLLECTION WAS DRAINED ON (B)(6) 2010, A LEFT PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED, CT AND X-RAYS WERE OBTAINED AND A RETROGRADE UROGRAM WAS PERFORMED. THE PATIENT THEN WENT TO SURGERY WHERE A CYSTOSCOPY, A NEPHROSTOG

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 PROSTATECTOMY PROCEDURE, THE PHYSICIAN AT THE SURGEON SIDE CONSOLE INTERMITTENTLY FELT A SHOCK IN HIS FINGERTIPS FROM THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE SURGEON SWITCHED TO THE SITE'S SECOND SURGEON SIDE CONSOLE TO COMPLETE THE PLANNED PROCEDURE AND NO FURTHER OCCURRENCES OF SHOCK WERE REPORTED. NO HARM TO THE PHYSICIAN OR PATIENT WAS REPORTED.

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 AND CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL FILING CLAIMS THAT AT SOME POINT DURING THE DA VINCI SI SURGICAL PROCEDURE THE PATIENT'S RIGHT OVARY WAS REMOVED WITHOUT HER CONSENT OR KNOWLEDGE. THE PATIENT REPORTEDLY DISCOVERED THAT HER RIGHT OVARY WAS MISSING AFTER UNDERGOING A SURGICAL PROCEDURE ON (B)(6) 2013 TO REMOVE HER LEFT OVARY. AFTER COMPLETION OF THE SURGICAL PROCEDURE PERFORMED ON (B)(6) 2013, THE SURGEON INFORMED THE PATIENT THAT THERE WAS SCAR TISSUE WHERE HER RIGHT OVARY SHOULD HAVE BEEN, AND THAT THE RIGHT OVARY WAS GONE. THE LEGAL FILING INDICATES THAT THE ONLY SURGICAL PROCEDURE THE PATIENT HAD PRIOR TO (B)(6) 2013, WAS THE DA VINCI PROCEDURE PERFORMED ON (B)(6) 2010.

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 APPROXIMATELY 2.5 HOURS INTO A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON BEGAN TO INITIATE A TOOL CHANGE TO SWITCH INSTRUMENTS. AT THIS TIME THE NURSE ASSISTANT WHO WAS RETRACTING THE PATIENT'S UTERUS, DROPPED THE UTERUS CAUSING THE SURGEON TO LOSE SITE OF THE TENNACULUM FORCEPS INSTRUMENT IN USE. THE PATIENT SIDE MANIPULATOR (PSM) ARM THAT THE TENNACULUM FORCEPS INSTRUMENT WAS INSTALLED ON BECAME UNRESPONSIVE. THE ISI REPRESENTATIVE ONSITE HAD THE SURIGCAL STAFF EMERGENCY STOP THE SYSTEM AND PERFORM A FAULT OVER-RIDE, HOWEVER, THE PSM CONTINUED TO BE UNRESPONSIVE. THE PATIENT'S UTERUS WAS MOVED, AND THE SURGICAL STAFF FOUND THAT THE TENNACULUM FORCEPS INSTRUMENT WAS CLOSED ON THE PATIENT'S RECTUM AND THEY WERE UNABLE TO RELEASE THE INSTRUMENT. WITH THE ASSISTANCE OF AN ISI TECHNICAL SUPPORT ENGINEER, THE INSTRUMENT WAS RELEASED AND REMOVED FROM THE PSM. A GENERAL SURGEON WAS REQUESTED TO ATTEND THE PROCEDURE AND ALTHOUGH THERE WERE NO VISIBLE HOLES, TEARS, OR PINCHES IN THE PATIENT'S RECTUM, HE PLACED A FEW SUTURES AS A PRECAUTION. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH OUT ANY FURTHER PATIENT HARM, INJURY OR ADVERSE OUTCOME REPORTED.

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 S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF MENORRHAGIA AND FIBROIDS. ACCORDING TO THE OPERATIVE REPORT OF THE DA VINCI S HYSTERECTOMY, THE SURGEON STATED THAT ENDOMETRIOSIS AND FIBROIDS WERE FOUND AROUND THE LEFT SIDE OF THE BROAD LIGAMENT. THE SURGEON ALSO STATED THAT THE URETER WAS DIFFICULT TO SEE AND IN TRYING TO DISSECT OUT THE FIBROIDS FROM THE PREPERITONEAL SPACE, THE URETER WAS INADVERTENTLY TRANSECTED. UROLOGY WAS CALLED FOR ASSISTANCE. A FIBROID WAS FOUND EXTENDING AROUND THE URETER ON THE LEFT AND WAS REMOVED. AT THAT POINT, THE SURGEON MADE THE DECISION TO COMPLETE THE PROCEDURE AS A SUPRACERVICAL HYSTERECTOMY. AFTER COMPLETION OF THE HYSTERECTOMY, A SURGEON FROM UROLOGY MADE THE DECISION TO OPEN THE PATIENT FOR OPEN REANASTOMOSIS OF THE URETER INTO THE BLADDER. THE SURGEON PERFORMED A LEFT URETERAL RE-IMPLANT WITH STENT PLACEMENT. THE PATIENT'S FOLEY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2010 AND ALLEGED TO HAVE INJURIES INCLUDING POSTOPERATIVE HEMORRHAGING. 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: ON MAY 8, 2012, INTUITIVE SURGICAL RECEIVED A LEGAL COMPLAINT THAT ALLEGED THE FOLLOWING: ON (B)(6) 2010, A PATIENT UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE WITH A LEFT SALPINGO-OOPHORECTOMY AT (B)(6). THERE WERE NO RECORDS OF ANY COMPLICATIONS DURING THE SURGERY AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT EXPERIENCED SEVERE PAIN IN HER LOWER ABDOMEN AND FEVER AND WAS SUBSEQUENTLY RE-ADMITTED TO (B)(6). THE PATIENT WAS IMMEDIATELY STARTED ON TRIPLE INTRAVENOUS ANTIBIOTIC THERAPY INCLUDING ROCEPHIN, GENTAMICIN, AND FAGYL. A DIAGNOSIS OF PELVIC ABSCESS ALONG THE VAGINAL CUFF WAS MADE. SECONDARY TO THIS, THE PATIENT HAD RADIOLOGY TESTS DONE, INCLUDING A CT SCAN OF THE ABDOMEN AND PELVIS WITH ORAL AND INTRAVENOUS CONTRAST, THAT CONFIRMED A LARGE MASS IN THE LEFT LOWER QUADRANT AND PELVIS HAVING INFLAMMATORY-TYPE FEATURES AND CONTAINING AIR MOST SUGGESTIVE OF AN ABSCESS. THE MASS WAS MEASURED TO BE 7.3 X 5.1 CENTIMETERS IN SIZE. THE READING RADIOLOGIST ALSO NOTED THAT THIS COULD ALSO BE A NECROTIC TYPE MASS WHICH COMMUNICATES WITH BOWEL. THE PATIENT WAS NOTED TO HAVE AN ELEVATED WHITE BLOOD CELL COUNT WITH A LEFT SHIFT CONSISTENT WITH SEPSIS. ON (B)(6

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY FOR PROSTATE CANCER ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: FOLLOW UP NOTES 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 OF A LOST NEEDLE. THE NEEDLE BECAME DISLODGED INTO THE PATIENT AND CONVERSION TO AN OPEN LAPAROTOMY WAS REQUIRED ADDING 2 HOURS TO THE CASE. TOTAL OPERATING TIME WAS 10 HOURS. THE SURGEON NOTED IN THE OPERATIVE REPORT THAT AT AROUND THE 1 O'CLOCK POSITION THE NEEDLE SNAPPED FROM THE SUTURE. I ATTEMPTED TO GRAB THE SUTURE TO KEEP TENSION IN ORDER TO PLACE A LAPRATY TO COMPLETE THE ANASTOMOSIS, HOWEVER, DURING THIS, THE NEEDLE HAD FALLEN AND WAS OUT OF MY SIGHT. WE LOOKED FOR THE NEEDLE DEEP IN THE PELVIS IN THE AREA WHERE IT HAD BECOME DETACHED FROM THE SUTURE, HOWEVER, WE WERE UNSUCCESSFUL IN SEARCHING FOR IT. KNOWING THAT THE LAPAROSCOPIC VISION WITH THE CAMERA WAS SUPERIOR THAN OPENING, WE DID TAKE OUR TIME SEARCHING FOR THE NEEDLE. INTRAO

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) 2009. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:HAD A FISTULA, HAD TO WEAR A CATHETER AND COLOSTOMY FOR 10 MONTHS, HOLE BETWEEN URETHRA AND BOWELS.

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 WHILE MOBILIZING THE LEFT INTERNAL MAMMARY ARTERY DURING A DA VINCI S CABG PROCEDURE, THE MICRO BIPOLAR FORCEPS (MBF) INSTRUMENT JUMPED FORWARD AND PUNCTURED THE PATIENT'S ARTERY. THE DAMAGED SECTION OF THE ARTERY WAS TRANSECTED AND THE HEALTHY PORTION OF THE ARTERY WAS USED TO COMPLETE THE BYPASS. IT WAS ALSO REPORTED THAT THROUGHOUT THE CASE, PNEUMO WAS ESTABLISHED AND LOST SEVERAL TIMES. THE ISI REPRESENTATIVE PRESENT DURING THE PROCEDURE INDICATED THAT PRIOR TO THE MBF INSTRUMENT JUMP, THE SURGEON NOTED THAT WHEN THE MASTER TOOL MANIPULATOR WAS MOVED, THE INSTRUMENT FELT STUCK AND THEN MOVED. IT IS BELIEVED THAT THE SURGEON CAUGHT THE MBF INSTRUMENT IN THE PATIENT'S RIB. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES OR PATIENT HARM.

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 BY THE PT THAT SHE RECENTLY HAD A DA VINCI HYSTERECTOMY PROCEDURE AND WAS UNDER ANESTHESIA FOR 8 HOURS INSTEAD OF THE EXPECTED 4 HOURS DUE TO HER BEING SEVERELY OVERWEIGHT. SHE STATED THAT SHE WOKE UP AND WAS UNABLE TO MOVE EITHER OF HER ARMS, HOWEVER, AFTER TIME, SHE WAS ABLE TO GET FULL USE OF HER LEFT ARM. SHE STATED HER RIGHT ARM IS STILL IN A LOT OF PAIN.

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 ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL OPERATIVE REPORTS AND HISTORY AND PHYSICAL DICTATION 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. 6 WEEKS AFTER SURGERY, THE PATIENT PRESENTED WITH COMPLAINED OF HAVING INTERCOURSE COMPLICATED BY SLIGHT VAGINAL BLEEDING AND THE LEAKAGE OF A WATERY FLUID. ON (B)(6) 2010, THE PATIENT WAS TAKEN BACK TO SURGERY FOR CYSTOSCOPY, AND INSPECTION OF URINARY TRACT. INDIGO CARMEN DYE TESTING FAILED TO SHOW ANY VESICO VAGINAL FISTULA AND THE URETERS APPEARED NORMAL ON RETROGRADE PYELOGRAM. A SINGLE SUTURE WAS USED TO CLOSE THE VAGINA. NO FURTHER INFORMATION WAS OBTAINED