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 SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2010, WHICH RESULTED IN DAMAGE, INCLUDING A LARGE RECTAL LACERATION WITH RECTO-VESICAL FISTULA THAT REQUIRED INTRAOPERATIVE REPAIR WITH SUTURES, A LOOP ILEOSTOMY AND FURTHER INPATIENT HOSPITALIZATION. THE LEGAL COMPLAINT ALSO INDICATED THAT THE PATIENT CONTINUES TO SUFFER FROM CHRONIC ABDOMINAL PAIN, INCONTINENCE, MULTIPLE HERNIAS AND INTESTINAL SCARRING WHICH HAS REQUIRED HIM TO UNDERGO MULTIPLE ADDITIONAL SURGICAL PROCEDURES. IN ADDITION, THE LEGAL COMPLAINT INDICATED THAT DUE TO THE INJURIES SUSTAINED DURING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT HAD AND WILL CONTINUE TO HAVE MULTIPLE PAINFUL ADDITIONAL MEDICAL TESTS AND PROCEDURES, PHYSICIAN CONSULTATIONS AND ADDITIONAL SURGERIES AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY.

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 SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE THE PATIENT EXPERIENCED UNSPECIFIED 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: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED 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: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNSPECIFIED 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 MEDIATION EFFORT, ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE DOCUMENTATION RECEIVED STATES THAT THE PATIENT DEVELOPED A PELVIC ABSCESS FOLLOWING A DA VINCI SI HYSTERECTOMY PROCEDURE AND WAS READMITTED TO THE HOSPITAL FOR FURTHER TREATMENT. THE OPERATIVE REPORT FOR (B)(6) 2010, INDICATED THAT THE PATIENT UNDERWENT A DA VINCI ASSISTED PELVIC HYSTERECTOMY IN ADDITION TO PLICATION OF THE UTEROSACRAL LIGAMENTS AND DRAINAGE OF BILATERAL OVARIAN CYSTS. THE PATIENT WAS FOUND TO HAVE AN ENLARGED UTERUS OF APPROXIMATELY 18 WEEKS WITH ABDOMINAL CYSTS. THERE WAS A CYST ON BOTH OVARIES CONTAINING CLEAR LIQUID. ACCORDING TO THE OPERATIVE REPORT, THE PATIENT'S LARGE UTERUS WAS PULLED OUT THROUGH THE VAGINA WITH SOME DIFFICULTY. THE VAGINAL CUFF WAS CLOSED WITH VICRYL SUTURE. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. AS PER THE MEDICAL RECORD ON (B)(6) 2010, THE PATIENT CAME IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF NAUSEA, VOMITING, AND NOT FEELING WELL. THE PATIENT'S MEDICAL RECORDS INDICATED THAT S

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)(4) 2012 ISI RECEIVED A LEGAL SUMMONS AND COMPLAINT INDICATING ON (B)(6) 2010, THE PATIENT UNDERWENT A DA VINCI S PARTIAL NEPHRECTOMY PROCEDURE AT (B)(6) MEDICAL CENTER. DURING THE SURGICAL PROCEDURE THE PATIENT SUSTAINED PERFORATION OF THE DUODENUM. BETWEEN (B)(6) 2010, THE PATIENT DEVELOPED AN ABSCESS, INFECTION AND SEPSIS. THE PATIENT DECEASED 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: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT SUSTAINED POST-OPERATIVE COMPLICATIONS RELATED TO CHRONIC PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI S HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. PRIOR TO THE PROCEDURE, THE PATIENT WAS INFORMED OF THE RISK OF SURGERY INCLUDING BLEEDING, INFECTION, INJURY TO OTHER ORGANS, A ROUGHLY 10% RISK OF OPEN SURGERY, TRANSFUSION, AND RESUSCITATION, AND SIGNED CONSENT. BASED ON THE OPERATIVE REPORT, THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE PROCEDURE. FROM (B)(6) 2010 THROUGH (B)(6) 2012, THE PATIENT HAD NUMEROUS CONSULTATIONS WITH VARIOUS PHYSICIANS FOR COMPLAINTS OF CHRONIC ABDOMINAL AND PELVIC PAIN. DURING THAT TIME, ALTHOUGH MULTIPLE CT SCANS, ULTRASOUND TESTS, AND MRI'S WERE PERFORMED, A DEFINITIVE ETIOLOGY FOR THE PATIENT'S SYMPTOMS COULD NOT BE DETERMINED. IN ADDITION, DURING THAT TIME THE PATIENT WAS UNABLE TO ACHIEVE COMPLETE SYMPTOMATIC RELIEF WITH

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE PERFORMED ON (B)(6) 2008, THE SURGEON EXPERIENCED INTERFERENCE IN THE LEFT EYE IMAGE VIEWED FROM THE SURGEON'S CONSOLE. THE SURGEON SWITCHED THE IMAGE FROM 3-DIMENSIONAL (3-D) TO 2-DIMENSIONAL (2-D) TO PROCEED WITH THE PROCEDURE. THE PLANNED SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED. THE CUSTOMER-REPORTED-EVENT DOES NOT IN ITSELF CONSTITUTE A REPORTABLE EVENT, HOWEVER, ON JUNE 17, 2010, ISI RECEIVED A LEGAL SUMMONS AND COMPLAINT FILED BY THE PATIENT, ALLEGING THAT DUE TO THE AMOUNT OF TIME ADDED BY COMPLETING THE SURGERY IN 2-D (THE SURGERY LASTED OVER 8 HOURS) THE PATIENT SUSTAINED A SEVERE AND PERMANENT RIGHT LEG INJURY, SPECIFICALLY RIGHT CALF COMPARTMENT SYNDROME. THE COMPLAINT FURTHER ALLEGES THAT THE PATIENT HAS UNDERGONE NUMEROUS AND EXTENSIVE MEDICAL PROCEDURES, INCLUDING SURGERY AND THERAPY.

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 25TH, 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE WITH RIGHT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2010. THE PATIENT WAS DIAGNOSED WITH A LARGE 16 WEEK SIZED FIBROID UTERUS AND RIGHT OVARIAN ADHESIONS TO THE UTERUS. THE DA VINCI HYSTERECTOMY PROCEDURE WITH RIGHT SALPINGO-OOPHORECTOMY WAS COMPLETED AS PLANNED AND THE PATIENT WAS PLACED IN THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE PATIENT'S POSTOPERATIVE COURSE WAS SIGNIFICANT FOR DEVELOPMENT OF ANEMIA, WHICH REQUIRED A TRANSFUSION OF TWO UNITS OF PACKED CELLS. THE PATIENT WAS DISCHARGED AS PLANNED. ON (B)(6) 2010 THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL EXPERIENCING A LOW GRADE FEVER, NAUSEA, VOMITING, ABDOMINAL PAIN AND A FEELING OF MALAISE. UPON EVALUATION THE PATIENT WAS FOUND TO HAVE DEVELOPED A FLUID COLLECTION IN HER PELVIS AND UNDERWENT A CT GUIDED PERCUTANEOUS DRAINAGE OF THE COLLECTION ON (B)(6) 2010. APPROXIMATELY 16 ML OF DARK BLOODY SEROSANGUINOUS FLUID WAS REMOVED. THE CT SCAN ALSO REVEALED THAT THE PATIENT'S SIGMOID COLON HAS PERICOLONIC INFLAMMATION. AN X-R

Robotic lawnmower — original manufacturers type designation: TC-G158Robotic lawnmower Hazard (Cuts, Injuries): The product poses a risk of cuts and injuries because: - the enclosure for the cutting mechanism does not extend below the cutting plane resulting in risk of objects being fired out and of body parts coming into contact with the cutting mechanism; - it is possible for a person to raise the machine horizontally from its normal working position and hence get access to the rotating blades, or to lift the m...

Robotic lawnmower — original manufacturers type designation: GardenerRobotic lawnmower Hazard (Cuts, Injuries): The product poses a risk of cuts and injuries because: - the enclosure for the cutting mechanism does not extend below the cutting plane resulting in risk of objects being fired out and the possibility of body parts coming into contact with the cutting mechanism; - it is possible for a person to raise the machine horizontally from its normal working position and hence get access to the rotating blades ...

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 RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT WAS BLEEDING A LOT AFTER SURGERY AND WAS LEAKING URINE FROM CATHETER, TRIED TO GET HELP FROM MEDICAL CENTER THE HEALTH CARE WORKER PUSHED CATHETER THROUGH BODY AND TWISTED 180 DEGREES, IT RIPPED OUT BLADDER NECK.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE PATIENT UNDERWENT A SUCCESSFUL AND UNEVENTFUL DA VINCI S RIGHT COLECTOMY PROCEDURE. TWO DAYS POST PROCEDURE, ON (B)(6), 2010, THE PATIENT WAS TAKEN BACK TO SURGERY FOR INTERNAL BLEEDING AT THE HEPATIC FLEXURE. THE BLEEDING WAS STOPPED AND THE PATIENT WAS BROUGHT TO ICU. AFTER RECOVERY THE PATIENT WAS DISCHARGED HOME AND IS REPORTED AS DOING WELL.

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 CARDIAC PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGED THAT THE PATIENT'S MAIN ARTERY WAS CUT DURING SURGERY AND SHE BLED TO DEATH. THE DATE OF THE PATIENT'S DEATH WAS NOT PROVIDED. INTUITIVE SURGICAL, INC. (ISI) WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI RADICAL PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION AND REPAIR OF A RECTAL TEAR FOR ADENOCARCINOMA OF THE PROSTATE ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORTS. CONSULTATION REPORTS FROM VARIOUS SURGEONS INVOLVED IN HIS SUBSEQUENT CARE ARE ALSO INCLUDED. 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 - A RECTAL TEAR. OPENING DENONVILLIERS' SPACE WAS NOTED TO BE DIFFICULT DUE TO THE PRESENCE OF A PARTICULARLY LARGE, FLOPPY BLADDER. THE BLADDER WAS ADHERED TO THE ANTERIOR ABDOMINAL WALL, WHICH MADE DISSECTION INTO THE SPACE OF RETZIUS PARTICULARLY DIFFICULT. LOCATION OF THE BLADDER NECK REQUIRED FURTHER DISSECTION, AS THE BLADDER WAS CONSTANTLY FLOPPING ON TO THE PROSTATE. SPECIMENS OF THE BLADDER NECK WERE FROZEN TO DETERMINE THE EXTENT OF DISSECTION REQUIRED, AND ADDITIONAL RESECTION WAS REQUIRED UPON RECEIPT OF THE RESULTS. UPON COMPLETION OF SEPARATING THE PROSTATE FROM THE REMAINING DENONVILLER FASCIA, A

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2010, THE PATIENT SUFFERED FROM NECROSIS AND DEVASCULARIZATION ALLEGEDLY FROM THE ELECTROCOAGULATION PROCESS, WHICH PREVENTED PROPER HEALING. POST SURGERY, THE PATIENT EXPERIENCED CONTINUOUS PAIN AND DRAINAGE. DURING A POSTSURGICAL VISIT, IT WAS DISCOVERED THAT THE PATIENT'S BOWEL WAS PROTRUDING INTO HER VAGINA AND SURGERY WAS PERFORMED ON (B)(6) 2010, TO ADDRESS THIS ISSUE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT APPROXIMATELY 1 TO 2 HOURS DURING A DA VINCI SI COLECTOMY / ABDOMINOPERINEAL RESECTION PROCEDURE, THE PATIENT BEGAN TO ABNORMALLY BLEED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGERY. NO PATIENT HARM WAS REPORTED. TWO DAYS POST THE DA VINCI SI PROCEDURE, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY 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 INJURIES AND DAMAGES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE PAIN, KIDNEYS SHUT DOWN, ANOTHER SURGERY ON (B)(6) 2010 SHOWED A 6 INCH TEAR IN BOWELS, SEPTIC AND PUT ON LIFE SUPPORT AND VENTILATOR, HERNIA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PT SCHEDULED FOR ROBOTIC LAPAROSCOPIC PROSTATECTOMY. AFTER THE PROCEDURE BEGAN AND THE ROBOT WAS DOCKED TO THE TROCARS, THE THIRD ARM WAS NOT BEING RECOGNIZED FROM THE ROBOTIC CONSOLE. SALES REP WAS PRESENT FOR CASE AND TRIED TROUBLESHOOTING AND SPEAKING WITH COMPANY REP. ALL ATTEMPTS WERE MADE TO RESOLVE THE ISSUE. THE SURGEON SPOKE WITH THE PT'S FAMILY AND A DECISION WAS MADE TO ABORT THE CASE AND RESCHEDULE FOR A LATER TIME. THE SURGICAL SERVICES DEPT. DIRECTOR CONTACTED THE COMPANY AND THE EQUIPMENT WAS SERVICED THE SAME DAY OF THE INCIDENT. THE EQUIPMENT WAS REPAIRED AND CLEARED FOR USE.

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 SUCCESSFUL DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST AND EXPIRED. 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 AFTER A DA VINCI SI HYSTERECTOMY PROCEDURE WAS PERFORMED ON (B) (6), 2010, THE PT CLAIMED TO HAVE NEUROPATHY. NO SYSTEM MALFUNCTION OCCURRED AND THE PLANNED PROCEDURE WAS SUCCESSFULLY 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 WHO UNDERWENT A DA VINCI ROBOTIC HYSTERECTOMY PROCEDURE FOR HYPERPLASIA ON (B)(6) 2011. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW-UP HOSPITAL AND 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) 2011,THE PATIENT UNDERWENT LAPAROSCOPY, LYSIS OF ADHESIONS, ROBOTIC HYSTERECTOMY, BILATERAL PELVIC LYMPHADENECTOMY, AND CYSTOSCOPY. IT WAS NOTED THAT THERE WAS EXTENSIVE ADHESIONS AND EXPOSURE. IT WAS ALSO NOTED THAT THE SITE USED A HARMONIC SCALPEL AND CAUTERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 IN STABLE CONDITION. ON (B)(6) 2011, THE PATIENT RETURNED TO HOSPITAL AFTER CT NOTED POSSIBLE ABSCESS VERSUS ENTEROCUTANEOUS FISTULA. ON (B)(6) 2011, THE PATIENT UNDERWENT EXPLORATORY LAPAROTOMY AND NOTED EXTENSIVE ADHESIONS AS WELL AS SMALL DEFECT IN SMALL BOWEL RESECTED WITH END-TO-END ANASTOMOSIS. NOTED OF AREAS OF INDURATION ON BOWEL. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON (B

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, RSO, BILATERAL PELVIC LYMPHADENECTOMY FOR ENDOMETRIAL CANCER ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: MEDICAL RECORDS RELATED TO POST OPERATIVE CARE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY . ON (B)(6) 2010, THE PATIENT PRESENTED TO ER WITH VAGINAL PRESSURE. RETURNED ON (B)(6) 2010 FOR VAGINAL CUFF DEHISCENCE AND SMALL BOWEL EVISCERATION. PATIENT UNDERWENT REPAIR OF VAGINAL CUFF VIA VAGINAL APPROACH AND CYSTOSCOPY. PATIENT WAS PLACED ON RESTRICTIONS AT DISCHARGE. DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2010. PATIENT WAS READMITTED 7/26/201 FOR ILEUS AND DISCHARGED ON (B)(6) 2010. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. (B)(6)

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 RADICAL CYSTECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION INCLUDING EXTERNAL ILIAC, INTERNAL ILIAC AND OBTURATOR NODES, AND ILEAL CONDUIT CREATION FOR BACILLUS CALMETTE-GUERIN (BCG) REFRACTORY INVASIVE BLADDER CANCER ON (B)(6) 2010. THE LEGAL DOCUMENT ALLEGES, PT HAD BLADDER REMOVED AND THEY BELIEVED THE SURGERY WENT WELL. PT BECAME ILL ON THE EVENING OF THE SURGERY AND WAS MOVED TO ICU. PT'S COLON WAS NICKED AND PT DIED 6 DAYS LATER. ISI WAS PROVIDED WITH THE OPERATIVE (OP) REPORT OF THE DA VINCI RADICAL CYSTECTOMY PROCEDURE. THERE WAS NO INDICATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IN ADDITION, THERE WAS NO REPORT OF AN INTRA-OPERATIVE COMPLICATION. AFTER COMPLETION OF THE ROBOTIC PORTION OF THE SURGERY, THE ROBOT WAS UNDOCKED. ISI WAS ALSO PROVIDED THE OP REPORT FOR THE SURGICAL PROCEDURE THAT IMMEDIATELY FOLLOWED THE ROBOTIC PORTION OF THE SURGERY. THE OP REPORT WAS FOR AN ILEAL CONDUIT URINARY DIVERSION AND URETEROILEAL REIMPLANTATION FOR BLADDER CANCER, MUSCLE-INVASI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED A HIGHER THAN NORMAL BLOOD LOSS REQUIRING A BLOOD TRANSFUSION. THE PATIENT WAS REPORTED AS BEING STABLE WHEN THE SURGICAL STAFF MADE THE DECISION TO CONTINUE WITH THE PROCEDURE WITHOUT INCIDENT. ONE DAY POST OPERATION, THE PATIENT WAS OBSERVED TO HAVE INTERNAL BLEEDING AND WAS BROUGHT IN THE OPERATING ROOM WHERE IT WAS DETERMINED THAT HER ILIAC ARTERY HAD BEEN NICKED. THE SURGICAL STAFF CONTROLLED THE BLEEDING BY PACKING THE AFFECTED AREA AND KEEPING THE PATIENT OVER THE WEEKEND. TWO DAYS LATER THE BLEEDING WAS FOUND TO BE UNDER CONTROL AND THE PACKING WAS REMOVED. NO ADDITIONAL PATIENT INJURY OR ADVERSE EVENT HAS BEEN REPORTED. THE SURGEON HAS REPORTED THAT THE PATIENT IS DOING WELL WITH NO FURTHER ISSUES.

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), 2010 (B)(6), RISK MANAGER AT (B)(6) HOSPITAL, SUBMITTED A LETTER AFTER REVIEWING MEDWATCH MANUFACTURER REPORT NUMBER 2955842-2010-00306 STATING: AT NO TIME DURING THE LAPAROSCOPIC PROCEDURE DID THE DA VINCI SI SURGEON SIDE CONSOLE EXPERIENCE A LOSS OF POWER WHILE IN USE NOR WAS THE AORTA NICKED AS INDICATED IN THE MEDWATCH REPORT. ALTHOUGH A CALL WAS PLACED BY OPERATING ROOM PERSONNEL TO AN INTUITIVE SURGICAL TECHNICAL SUPPORT FIELD ENGINEER ON (B)(6), THIS CALL WAS PLACED AFTER THE PROCEDURE CONCLUDED. IT WAS NOTED DURING A CHECK OF THE EQUIPMENT AFTER THE PROCEDURE THAT THE SURGICAL SIDE CONSOLE WOULD NOT POWER ON. IT IS MY UNDERSTANDING THAT DURING THE TROUBLESHOOTING CONVERSATION BETWEEN THE OPERATING ROOM PERSONNEL AND THE TECHNICAL SUPPORT FIELD ENGINEER THAT IT WAS REPORTED TO THE TECHNICAL SUPPORT FIELD ENGINEER THAT A DEFIBRILLATOR HAD BEEN PLUGGED INTO THE SAME ELECTRICAL WALL SOCKET AS THE SURGICAL SIDE CONSOLE AND THAT THE DEFIBRILLATOR HAD BEEN ACTIVATED. PLEASE BE ADVICED THAT THE DEFIBRILLATOR WAS NOT ACTIVATED DURING THE DA VINCI 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: IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI S PROSTATECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLINDNESS. THE PATIENT HAS BEEN SEEN BY A NUERO OPTOMOLOGIST WHO CONFIRMED THAT THE BLINDNESS WAS PERMANENT.

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 SUPRACERVICAL HYSTERECTOMY WITH RIGHT SALPINGO-OOPHORECTOMY FOR SYMPTOMATIC FIBROIDS THAT DISPLACED THE ENDOMETRIAL CANAL, DYSFUNCTIONAL IRREGULAR HEAVY UTERINE BLEEDING, AND ANEMIA ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH ALL OPERATIVE REPORTS. ADDITIONAL INFORMATION PROVIDED INCLUDES: HISTORY AND PHYSICAL (H&P) (B)(6) 2010, HOSPITALIST CONSULTATION (B)(6) 2010, DISCHARGE SUMMARY (B)(6) 2010, MEDICAL CONSULTATION (B)(6) 2010, INTRAOPERATIVE GEN. SURGICAL CONSULTATION (B)(6) 2010, DISCHARGE SUMMARY (B)(6) 2010. 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, A SUBUMBILICAL INCISION WAS MADE THROUGH A PREVIOUS LAPAROSCOPIC SCAR AND A TROCAR INSERTED. AFTER PLACEMENT OF 3 ADDITIONAL TROCARS THE LEFT FALLOPIAN TUBE WAS CLAMPED, CAUTERIZED AND CUT WITH THE LIGASURE DEVICE LAPAROSCOPICALLY. MOBILIZATION OF THE UTERUS WAS CONTINUED BY TAKING DOWN FIRST THE LEFT-SIDED LATERAL LIGAMENTS (UTERO-OVARIAN L

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.