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 TO ISI THAT A FEW DAYS AFTER A DA VINCI SI PYLOROPLASTY PROCEDURE, THE PATIENT EXPERIENCED PROBLEMS WITH HIGH FEVER. AFTER CONSULTING WITH HIS SURGEON, HE WAS BROUGHT BACK TO THE EMERGENCY ROOM FOR AN EXPLORATORY SURGERY. IT WAS ALLEGED THAT DURING THE OPEN TRADITIONAL SURGERY A 3CM HOLE WAS FOUND ON THE PATIENT'S BOWEL. IT WAS REPORTED THAT THE SURGEON REMOVED 6 OF THE PATIENT'S COLON AND A COLOSTOMY BAG WAS INSTALLED. THE PATIENT WAS LATER TRANSFERRED FROM THE INTENSIVE CARE UNIT TO A PRIVATE ROOM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER OF A SUCCESSFUL DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE CANNULA FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED BURN MARKS ON THE SURFACE OF THE SKIN ASSOCIATED WITH PATIENT SIDE MANIPULATOR (PSM) ARM 2.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED INJURIES AND DAMAGES. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER OF A SUCCESSFUL DAVINCI SI HYSTERECTOMY PROCEDURE, WHILE THE SURGICAL STAFF WAS REMOVING THE CANNULA FROM THE PATIENT, IT WAS NOTED THAT THE PATIENT SUSTAINED BURN MARKS ON THE SURFACE OF THE SKIN. THIS MDR WAS CREATED TO ADDRESS THE EVENT OCCURRED ON (B)(6) 2013; REPORTED BY DAVINCI COORDINATOR ON RELATED MDR 2955842-2013-00666.

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 AND CYSTOSCOPY FOR ENDOMETRIAL HYPERPLASIA, MENORRHAGIA AND DYSMENORRHEA ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, AND THE PROCEDURE REPORTS FOR URETERAL STENT PLACEMENT AND STENT REMOVAL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. THE SURGERY WAS PERFORMED WITH FENESTRATED BIPOLAR AND AN UNSTATED INSTRUMENT WITH ROUTINE CAUTERIZATION AND TRANSECTION OF UTERO-OVARIAN LIGAMENTS, ARTERIES AND FALLOPIAN TUBES WITH VAGINAL DELIVERY OF THE UTERUS, CAUTERY OF BLEEDERS ON THE VAGINAL VAULT, AND CLOSURE WITH BARBED SUTURE. UPON ROUTINE CYSTOSCOPY WITH INDIGO CARMINE, IT WAS NOTED THAT THERE WAS NO EFFLUX FROM THE RIGHT URETERAL ORIFICE. A UROLOGIST WAS CONSULTED WHO PERFORMED BILATERAL RETROGRADE PYELOGRAMS. HE PLACED A 6 FRX26 CM DOUBLE PIGTAIL STENT IN THE RIGHT URETER BECAUSE OF THE CONCERN THAT THE HYDROURETERAL NEPHROSIS INDICATED THERMAL INJURY TO THE URETER. THE SURGERY WAS COMPLETED, AND PATIENT DISCHARGED WITH STENT. ON (B)(6) 2013, PATIENT HAD A C

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 WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2013. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF UTERINE FIBROIDS AND HISTORY OF BREAST CANCER. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON STATED THAT THE SURGICAL STAFF HAD DIFFICULTY WITH VISUALIZATION SINCE THERE WAS A LARGE FIBROID THAT WAS ANTERIOR IN THE LOWER UTERINE SEGMENT. AT THAT POINT, THE 30-DEGREES CAMERA WAS REPLACED WITH A STRAIGHT CAMERA AND VISUALIZATION WAS NOTED AS BEING BETTER. DUE TO THE LARGE SIZE OF THE UTERUS, THE SURGICAL STAFF FACED DIFFICULTIES REMOVING THE UTERUS VAGINALLY. HENCE, AFTER THE VAGINAL CUFF WAS CLOSED, THE DA VINCI SYSTEM WAS UNDOCKED AND THE UTERUS, TUBES, AND OVARIES WERE REMOVED BY LAPAROSCOPIC MORCELLATION. THE PELVIS WAS WELL IRRIGATED AND THE PATIENT HAD GOOD HEMOSTASIS. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. SHE WAS DISCHARGED FROM THE HOSPITAL 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: AN ARTICLE ENTITLED PATIENT SAYS BROKEN DA VINCI ROBOT CAUSED A PERFORATED COLON THAT LED TO DISTURBING GI COMPLICATIONS PUBLISHED ON (B)(4) 2011 BY (B)(4) WAS PROVIDED TO INTUITIVE SURGICAL ON (B)(4) 2013. THE ARTICLE ALLEGES THAT DURING THE PATIENT'S PROSTATECTOMY PROCEDURE IN JANUARY 2007 THE SYSTEM MALFUNCTIONED AND THE SURGICAL PROCEDURE WAS CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. THE PATIENT WAS REPORTED TO HAVE GONE INTO RECOVERY IN GOOD CONDITION, HOWEVER, ON HIS WAY HOME FROM THE HOSPITAL HE SENSED THAT THE PROSTATECTOMY HAD GONE WRONG. THE ARTICLE ALLEGED THAT THE PATIENT BEGAN URINATING OUT OF HIS RECTUM AND NOTICED THAT DARK MATTER WAS COMING OUT OF HIS PENIS.

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 UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY, LYSIS OF ADHESIONS AND CYSTOSCOPY FOR ABNORMAL UTERINE BLEEDING AND PELVIC PAIN ON (B)(6) 2013. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. MULTIPLE SEVERE ADHESIONS WERE ENCOUNTERED DURING THE PROCEDURE, THE UTERUS WAS STUCK TO THE ANTERIOR ABDOMINAL WALL. OVARIAN CYSTS WERE PRESENT. A CYSTOSCOPY WAS PERFORMED POST-PROCEDURE TO ENSURE THAT NO DAMAGE WAS DONE TO THE BLADDER OR URETERS. THE PATIENT WAS DISCHARGED TO HER RESIDENCE THE FOLLOWING DAY, (B)(6)2013 IN STABLE CONDITION. DURING A POST-OPERATIVE VISIT ON (B)(6) 2013 THE PATIENT COMPLAINED OF POST-OPERATIVE PELVIC PAIN. SHE WAS ADMITTED TO THE HOSPITAL, WHERE A CT SCAN REVEALED A MIXED-DENSITY MASS ABOVE THE PATIENT'S BLADDER AND POTENTIAL URETERAL DILATION, BUT THE IMAGES WERE OF POOR QUALITY. BLOOD TEST SHOWED CREATININE IS 0.71, SODIUM 139, POTASSIUM 3.5, CALCIUM 9.4. LIVER FUNCTION WAS NORMAL. HEMO

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THIS INITIAL MDR IS ACTUALLY BEING SUBMITTED AS A FOLLOW-UP #1 MDR REPORT FOR MFR REPORT #2955842-2014-02551 (PATIENT IDENTIFIER (B)(6)). THE COMPLAINT HANDLING SYSTEM THAT WAS USED TO SUBMIT THE INITIAL MDR IS NO LONGER AVAILABLE FOR MDR REPORT SUBMISSIONS. IN RELATION TO THE REPORTED EVENT, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE PLAINTIFF¿S ATTORNEY: THE DEATH CERTIFICATE INDICATED THAT THE PATIENT¿S CAUSE OF DEATH WAS ¿SEPSIS¿ DUE TO OR AS A CONSEQUENCE OF ¿ACUTE OR CHRONIC RESPIRATORY FAILURE,¿ DUE TO OR AS A CONSEQUENCE OF ¿FALLOPIAN TUBE DAMAGE,¿ DUE TO OR AS A CONSEQUENCE OF ¿COPD AND OSA.¿ BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: THE PATIENT DEVELOPED A PELVIC ABSCESS AND SEPTIC SHOCK, AND SUBSEQUENTLY PASSED AWAY APPROXIMATELY 6 WEEKS AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S ALLEGED PELVIC ABSCESS IS STILL UNKNOWN.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY FOR FIBROIDS ON (B)(6) 2013. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND SUPPLEMENTAL HOSPITAL MEDICAL RECORDS. ACCORDING TO THE OPERATIVE REPORT, THE SURGEON NOTED THAT THERE WAS SOME DIFFICULTY PLACING TROCARS DUE TO DENSE INTRA-ABDOMINAL ADHESIONS. PERTINENT FINDINGS INCLUDED ADHESIONS OF THE BOWEL AND OMENTUM TO THE ANTERIOR ABDOMINAL WALL. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT, AND/OR AN ACCESSORY DURING THE OPERATION. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. AFTER THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED, THE PATIENT PRESENTED WITH THE FOLLOWING: ON (B)(6) 2013 THE PATIENT PRESENTED WITH LEAKING FLUID FROM HER VAGINA. A CYSTOSCOPY WAS PERFORMED WITH BILATERAL RETROGRADE PYELOGRAPHY. NO URINARY INJURY WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY WAS INITIATED BUT THEN ABANDONED DUE TO ADHESIONS. ON (B)(6) 2013, AN EXPLORATORY LAPAROTOMY WAS THEN PERFORMED. THE BOWEL WAS FOUND TO BE DENSELY ADHERENT TO THE UPPER ANTERIOR ABDOMINAL WALL. PELVIC ABSCESSES WERE IDENTIFIED AND

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S PROSTATECTOMY PROCEDURE, DURING STARTUP OF THE DA VINCI S SYSTEM, THE CUSTOMER EXPERIENCED A PROBLEM WITH ERROR CODE 45341. THE SITE CONTACTED ISI FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND THAT THE SYSTEM ERROR CODE 45341 WAS RELATED TO THE VIDEO PROCESS ASSEMBLY ON THE DA VINCI S ROBOT SYSTEM. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM OR INJURY WAS INITIALLY 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 ON (B)(6) 2013, INTUITIVE SURGICAL RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE DUE TO ABNORMAL UTERINE BLEEDING. ACCORDING TO THE PATIENT'S OPERATIVE (OP) REPORT THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. ACCORDING TO THE INFORMATION IN THE OP REPORT, DURING THE SURGICAL PROCEDURE, A SMALL ARTERIAL BLEEDER FROM WHAT APPEARED TO BE FROM AN ASCENDING CERVICAL BRANCH WAS APPRECIATED. THERE WERE CONCERNS ABOUT FURTHER CONTINUATION OF CAUTERY ENERGY IN THIS AREA AND A CLIP WAS APPLIED TO CONTROL THE BLEEDING. BASED ON THE INFORMATION AS PROVIDED IN THE OP REPORT THERE WERE NO OTHER ISSUES ENCOUNTERED DURING THE SURGICAL PROCEDURE. AFTER COMPLETION OF THE SURGICAL PROCEDURE THE PATIENT'S URINE WAS FOUND TO BE CLEAR. A CYSTOSCOPE WAS PLACED AND IT WAS CONFIRMED THAT THERE WAS NO TRAUMA TO THE PATIENT'S URINARY COLLECTING SYSTEM, AS THE BLADDER MUCOSA WAS CLEAR. INDIGO CARMINE FROM BOTH URETERS WAS OBSERVED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD 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: IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER SUCCESSFUL COMPLETION OF A DA VINCI SI SINGLE SITE CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AS A RESULT OF AN ALLEGED BOWEL PERFORATION. REPORTEDLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES 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 HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: RUPTURED BLOOD VESSELS, PATIENT STILL HAS NO FEELING IN HER THIGHS, NOW PRONE TO UTIS AND PAINFUL INTERCOURSE.

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 TRANSORAL ROBOTIC SURGERY (TORS), THE PATIENT SUFFERED A LIP BURN. IT WAS CONFIRMED THAT THE INCORRECT 3-PRONGED GROUNDING PAD WAS USED. THE SITE WAS PHYSICALLY REMOVING THE THIRD PIN IN ORDER TO CONNECT IT TO THE CANNULA. THIS COULD BE A POSSIBLE FAILURE MECHANISM AS THIS WOULD CONSTITUTE AN UNVALIDATED USE OF THE PRODUCT.

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. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE OPERATIVE (OP) REPORT FOR THE PATIENT'S HYSTERECTOMY PROCEDURE ON (B)(6) 2013 WAS NOT PROVIDED. THE PATIENT'S MEDICAL SUMMARY ALLEGES THAT THE PATIENT UNDERWENT THE DA VINCI HYSTERECTOMY PROCEDURE SECONDARY TO FAILED MEDICAL MANAGEMENT OF DYSMENORRHEA AND MENORRHAGIA. THE SURGICAL PROCEDURE WAS APPARENTLY COMPLICATED DUE TO DENSE PELVIC ADHESIONS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH HER POSTOPERATIVE COURSE COMPLICATED BY PANIC ATTACK. POST OPERATIVELY THE PATIENT REPORTED THAT SHE HAD SOME RIGHT SHOULDER PAIN AS WELL AS BLOATING AND WAS MANAGED CONSERVATIVELY WITH REST, HYDRATION AND STOOL SOFTENERS, HOWEVER, HER PAIN WORSENED. THE PATIENT'S MEDICAL REPORTS PROVIDED STATE THAT WHEN THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013, THE PATIENT DESCRIBED HER PAIN AS BEING SO INTENSE THAT SHE COULD NOT EAT OR DRINK. THE PATIENT ALSO REPORTED FEVER AND VOMITING. ABDOMEN AND PELVIC CT TESTS WERE ORDERED. NO SIGNIFICANT INTRA-ABDOMINAL FINDINGS NOTED. IN THE RIGHT

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 TWO WEEKS AFTER COMPLETION OF A DA VINCI SI HYSTERECTOMY PROCEDURE, IT WAS DISCOVERED DURING A POST-SURGICAL CHECK-UP THAT THE PATIENT DEVELOPED ERYTHEMA AT TWO OF THE PORT SITE INCISIONS. THE AFFECTED PORT SITES WERE LOCATED AT THE UPPER LEFT AND UPPER RIGHT QUADRANTS. REPORTEDLY, A PK DISSECTOR INSTRUMENT WAS INSTALLED IN THE UPPER LEFT QUADRANT PORT SITE AND A MONOPOLAR CURVED SHEARS (MCS) INSTRUMENT WAS INSTALLED IN THE UPPER RIGHT QUADRANT DURING THE SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE INFORMATION ALLEGES THAT DURING THE SURGICAL PROCEDURE, THE PATIENT'S SIGMOID COLON WAS DAMAGED PER THE ON (B)(6) 2013, PER THE INFORMATION RECEIVED. THE PATIENT VISITED THE HOSPITAL EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. THE PATIENT UNDERWENT A DIAGNOSTIC LAPAROSCOPY AND EXPLORATORY LAPAROTOMY ON (B)(6) 2013 TO REPAIR DAMAGE TO THE SIGMOID COLON. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013 THE PATIENT RETURNED TO THE HOSPITAL WITH EXCESSIVE SWELLING TO HER LEGS. HER PHYSICIANS REPORTEDLY SUSPECTED DEEP VEIN THROMBUS; HOWEVER, THAT WAS RULED OUT AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2013 THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH A C-DIFF INFECTION. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT'S URETER WAS DAMAGED. DURING REPAIR OF THE PATIENT'S URETER BY THE SITE'S UROLOGIST, THE UROLOGIST NOTED THAT THE JAW ON THE ENDOWRIST INSTRUMENT INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WAS NOT ARTICULATING CORRECTLY. REPORTEDLY, THE SITE REPLACED THE INSTRUMENTS MULTIPLE TIMES AND REPLACED THE DRAPE; HOWEVER, THE ISSUE PERSISTED. THE SITE REPORTED THAT DURING INSTALLATION OF THE STERILE ADAPTER ONTO THE PSM, IT WAS NOTED THAT THE STERILE ADAPTER DID NOT APPEAR TO ENGAGE FULLY WITH THE PSM. UNABLE TO RESOLVE THE ISSUE, THE SURGEONS MADE THE DECISION TO REPAIR PATIENT'S URETER AND COMPLETE THE SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A SUCCESSFUL ESOPHAGECTOMY PROCEDURE, THE PATIENT WAS DOING WELL FOR EIGHT DAYS POST SURGERY, ACCORDING TO THE SURGEON. HOWEVER, THE PATIENT LEAKED ON THE EVENING OF THE EIGHTH DAY AND HAD TO GO TO THE EMERGENCY ROOM. REPORTEDLY, THE ANASTAMOSIS HAD TO BE TAKEN APART AND CERVICAL ESOPHAGECTOMY HAD TO BE PERFORMED INSTEAD, ENDING THE ESOPHAGUS AS AN OSTOMY AT THE NECK. NO FURTHER INFORMATION WAS PROVIDED 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: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON HAD ARTICULATION ISSUES WITH ONE OF THE PATIENT SIDE MANIPULATORS (PSM). THE STAFF REPORTEDLY RE-SEATED THE INSTRUMENT AND EVENTUALLY REPLACED THE DRAPE ON THAT PSM. HOWEVER, THE ISSUE PERSISTED INTERMITTENTLY. IT WAS STATED THAT THE ARM JUMPED, CAUSING THE INSTRUMENT HELD IN THAT PSM TO STAB AN ARTERY, WHICH LED TO SOME BLEEDING THAT THE SURGEON WAS ABLE TO CONTROL WITHOUT CONVERTING THE PROCEDURE. THE SCHEDULED PROCEDURE WAS COMPLETED SUCCESSFULLY.

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 INITIALLY REPORTED THAT DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE, THE BIPOLAR INSTRUMENT FIRED UNINTENTIONALLY DURING A PROCEDURE ACCORDING TO THE INFORMATION PROVIDED TO THE CLINICAL SALES REPRESENTATIVE (CSR), THE CUSTOMER ALLEGED THAT WHILE THEY WERE INSTALLING THE BIPOLAR INSTRUMENT TO THE DAVINCI ROBOT SYSTEM, AS THEY CONNECTED THE BIPOLAR INSTRUMENT CABLE TO THE VALLEYLAB GENERATOR, THE ELECTROSURGICAL UNIT (ESU) MADE A FIRING TONE AND THE BIPOLAR INSTRUMENT FIRED. THE INSTRUMENT TIP DID TOUCH THE PATIENT'S UTERUS (WHICH WAS EVENTUALLY REMOVED). ACCORDING TO THE INFORMATION PROVIDED TO THE CSR, THE CUSTOMER WAS ABLE TO SUCCESSFULLY COMPLETE THE CASE PLUS TWO ADDITIONAL CASES USING THE SAME GENERATOR WITH NO FURTHER INCIDENTS.

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 S HYSTERECTOMY PROCEDURE, A BOWEL PERFORATION WAS DISCOVERED POST SURGERY. THE SURGEON REPORTEDLY STATED THAT THE INJURY MAY HAVE OCCURRED WHILE INSERTING THE CAMERA CANNULA, OR WHEN CUTTING THROUGH THE FASCIA. NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENT(S) AND/OR ACCESSORIES WERE REPORTED DURING THE COURSE OF THIS PROCEDURE.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED ALLOGRAFT COLPOPEXY, CYSTOCELE REPAIR, TVT MID URETHRAL TAPE WITH CYSTOSCOPY FOR TOTAL VAGINAL PROLAPSE WITH SEVERE CYSTOCELE, RECTOCELE AND ENTEROCELE AND URINARY INCONTINENCE ON (B)(6) 2012. ISI WAS PROVIDED WITH THE DA VINCI SURGERY OPERATIVE REPORT AND ADDITIONAL MEDICAL RECORDS. PER THE OPERATIVE REPORT, SURGICAL FINDINGS INCLUDED SIGNIFICANT ADHESIONS OF LOOPS OF SMALL BOWEL TO THE PELVIS, CUL-DE-SAC IN THE MIDLINE, AND RIGHT SIDE WALL. THE SURGEON PERFORMED THE LYSIS OF ADHESIONS ROBOTICALLY AND THE SACRAL COLPOPEXY AND TVT PORTIONS OF THE SURGERY. ANOTHER SURGEON PERFORMED THE RECTOCELE AND ENTEROCELE REPAIR PROCEDURES. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING THE DA VINCI SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2012. ON (B)(6) 2013, PER A UROGYNECOLOGY OFFICE NOTE, THE FOLLOWING WAS NOTED, FEELING SORE IN ABD, REPORTED 'PURPLE LINES' NO EVIDENCE OF INFECTION, AND NO ANTIBIOTICS. IN ADDITION, THE PATIENT WAS USING IBUPROFEN FOR PAIN. THERE WAS NO OXYCODONE USE. TH

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 DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AN EMERGENCY CONVERSION TO OPEN SURGERY DUE TO LACK OF VISUALIZATION HAD OCCURRED. THE PATIENT EXPIRED DURING THE OPEN PROCEDURE. THERE WERE NO REPORTS OF ANY SYSTEM, INSTRUMENT(S) AND/OR ACCESSORY(IES) MALFUNCTION DURING THE COURSE OF THE PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2012 AND ALLEGED TO HAVE INJURIES INCLUDING A THERMAL INJURY TO THE URETER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DAMAGED HER BLADDER, NO FEELING FROM HER BELLY BUTTON DOWN TO LEFT QUADRANT INSIDE INNER THIGH, INCONTINENCE, SEVERE PAIN, BLADDER WAS NICKED 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: THE PT IS A (B)(6) FEMALE ADMITTED TO (B)(6) MEDICAL CENTER ON (B)(6) 2012, FOR A SCHEDULED SURGERY. THE PT HAD BEEN DIAGNOSED WITH A RETROPERITONEAL LYMPHADENOPATHY. THE PLANNED SURGERY WAS A ROBOTIC ASSISTED PERIPANCREATIC LYMPH NODE EXCISION. DURING THE PROCEDURE TO EXCISE THE LYMPH NODE THE SURGEON NOTICED THAT THE CAUTERY HOOK WAS MALFUNCTIONING. THE MALFUNCTION DEVICE WAS REMOVED. UPON REMOVAL OF THE CAUTERY HOOK, IT WAS NOTED THAT PART OF THE PLASTIC CASING AROUND THE PULLEY OF THE HOOK WAS BROKEN OFF. THE SURGICAL TEAM IMMEDIATELY BEGAN EXTENSIVE SEARCH IN THE AREA OF THE LYMPH NODE DISSECTION, UNDERNEATH THE LIVER AND AROUND THE PORTA HEPATIS, BUT DID NOT SEE ANY EVIDENCE OF THE BROKEN PLASTIC CASING. SEVERAL ATTEMPTS WERE MADE TO LOCATE THE MISSING FRAGMENT INCLUDING CREATING A HAND PORT IN THE UPPER MIDABDOMEN. A FLAT PLATE KUB WAS TAKEN. THE TEAM WAS UNABLE TO LOCATE THE MISSING FRAGMENT. THE PT REMAINED STABLE THROUGHOUT THE SURGERY AND AT THE CONCLUSION OF THE PROCEDURE WAS TAKEN BACK TO RECOVERY IN STABLE CONDITION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON AUGUST 16TH, 2013 INTUITIVE SURGICAL, INC. RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WITH HISTORY OF IRREGULAR MENSTRUAL PERIODS AND AN ENLARGED FIBROID UTERUS WHO EXPERIENCED POST-SURGICAL COMPLICATIONS AFTER UNDERGOING A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY. ACCORDING TO THE OPERATIVE REPORT FOR (B)(6) 2012, DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGECTOMY WAS PERFORMED FOLLOWED BY CYSTOSCOPY. INDIGO CARMINE WAS ADMINISTERED INTRAVENOUSLY; BLUE DYE WAS VISUALIZED COMING FROM THE RIGHT URETERAL ORIFICE BUT NOT FROM THE LEFT. THE UROLOGIST WAS CONSULTED AND HE WAS ABLE TO PASS A DOUBLE-J STENT UP THE LEFT URETER. THE STENT WAS INTENDED TO BE IN PLACE FOR SIX WEEKS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. THE OPERATIVE REPORTS DO NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. ON (B)(6) 2013 THE PATIENT UNDERWENT A CYSTOSCOPY, LEFT DOUBLE-J STENT REMOVAL, LEFT RETROGRADE PYELOGRAM, RIGHT RETROGRADE PYELOGRAM, LEFT DISTAL SEMIRIGID URETEROSCOPY, BALLO

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 KIDNEY SURGERY ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INTERNAL BLEEDING AND ARTERY WAS CUT BY MISTAKE, CONSTANT AND EXTREME PAIN.

On December 15, 2012, Employee #1, a 38-year-old male with Sodecia Sterling Heights was inside a robot work cell with the interlocked gates closed. Employee #1 was struck from behind by a transfer robot, crushing his chest and neck. Employee #1 was killed in the event. Employee #1 had lock attached to his belt loop.

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 COMPLETION OF GENERAL SURGICAL PROCEDURE USING TRADITIONAL LAPAROSCOPIC TECHNIQUES AND THE DA VINCI S SURGICAL SYSTEM, THE SURGEON WAS CONCERNED THAT HE MAY HAVE HIT THE PATIENT'S BOWEL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED A LEGAL COMPLAINT CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI SURGICAL PROCEDURE ON (B)(6) 2012. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUFFERED A PERFORATED COLON AND EXPERIENCED INTENSE PAIN AND STOOL DRAINAGE FROM THE SURGICAL SITE, DEVELOPED A SEVERE INFECTION, AND UNDERWENT AN EMERGENCY REPAIR, DEBRIDEMENT, AND ABDOMINAL WASHOUT PROCEDURE TWO DAYS LATER. THE LEGAL COMPLAINT ALSO INDICATED THAT THE PATIENT HAD CONSIDERABLE PAIN, DISABILITY, CONVALESCENCE AND DISFIGUREMENT THEREAFTER.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI HERNIA REPAIR ON (B)(6) 2012. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY, OR ITS IMPROPER AND / OR UNLAWFUL USE, THE PATIENT SUFFERED AN ESOPHAGEAL RUPTURE RESULTING IN 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. RECEIVED VOLUNTARY REPORT MW5030296 WITH THE FOLLOWING DESCRIPTION: MD PERFORMED A ROUTINE HYSTERECTOMY USING A DA VINCI ROBOT AT XX IN XX. HE DAMAGED (CUT) MY LEFT URETER CAUSING A FISTULA. DR XX DIDN'T REALIZE IT AT THE TIME OF SURGERY AND I WAS RELEASED. THIS FISTULA CAUSED MY KIDNEY TO MALFUNCTION REQUIRING EMERGENCY HOSPITALIZATION. IT WAS STILL UNDIAGNOSED WHILE IN THE HOSPITAL. ON XX 2013 DR XX ORDERED A CT SCAN TO DETERMINE THE CAUSE OF THE FISTULA. I HAD OUTPATIENT SURGERY ON XX 2013 AND A NEPHROSTOM TUBE WAS INSERTED INTO MY KIDNEY. ON XX 2013 DR XX PERFORMED ANOTHER OUTPATIENT SURGERY AND PUT A DOUBLE J STENT INTO MY DAMAGED URETER WHICH WAS IN FOR 6 WEEKS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY FOR MENORRHAGIA, DYSMENORRHEA, AND PELVIC PAIN ON (B)(6) 2012. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. OTHER CONSULTANTS NOTES ARE INCLUDED. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION SPECIFICALLY, A NARROWING OF THE RIGHT URETER POST PROCEDURE REQUIRING AN INTRA-OPERATIVE CONSULTATION FROM A UROLOGIST WHO WAS ABLE TO PASS A GLIDEWIRE AND A RIGHT URETERAL STENT PAST THE POINT OF NARROWING INTO THE RIGHT KIDNEY. THE PATIENT THEN HAD TO LEAVE THE STENT IN PLACE AND RETURN AT 6 WEEKS TO HAVE IT REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL 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: I WAS USING THE DAVINCI SYSTEM FOR A HYSTERECTOMY ON A (B)(6). THE PRECISE BIPOLAR INSTRUMENT WAS INSERTED AND WHEN I GRASPED TISSUE THE CURRENT ACTIVATED WITHOUT THE FOOT PEDAL BEING PRESSED. THE AUDIBLE POWER SOUND WAS HEARD AND THE GRASPED TISSUE WHICH FORTUNATELY WAS A FALLOPIAN TUBE WAS CAUTERIZED. THE ENTIRE CREW IN THE OPERATING ROOM WITNESSED THIS EVENT. I THEN GRASPED THE UTERUS IN SEVERAL LOCATIONS AND THE INSTRUMENT AGAIN TRANSMITTED ENERGY WITH THE GRASPING OF TISSUE WITHOUT USE OF THE FOOT PEDAL. THE DEVICE WAS REMOVED AND THE PK DEVICE INSERTED, TESTED AND THE CASE PROCEEDED WITHOUT INCIDENT. EXAM OF THE BOWEL AND SURROUNDING TISSUE DISCLOSED NO INJURY AND THE PT WAS DISCHARGED THE NEXT MORNING. THIS ONLY OCCURRED 2 DAYS AGO HOWEVER SO POTENTIAL FOR DELAYED INJURY STILL EXISTS. A SIMILAR EVENT HAD OCCURRED 2 MONTHS AGO USING A FENESTRATED BIPOLAR DEVICE ON THE SAME SYSTEM AND GENERATOR WHERE UPON INSERTION OF THE INSTRUMENT ENERGY WAS IMMEDIATELY DELIVERED PRIOR TO FOOT PEDAL ACTIVATION. THE DEVICE WAS DISCONNECTED, REINSERTED AND THE PROBLEM DID NOT RECUR ON THE SECOND ATTEMPT.

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 PROCEDURE ON (B)(6) 2012. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS ALLEGED TO HAVE SUSTAINED A THERMAL BURN TO A URETER WHICH LED TO EXTRAVASATION OF THE URETER. ON (B)(6) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPARTMENT AT THE SITE. THE RISK MANAGER REVIEWED THE OPERATIVE REPORT AND DID NOT SEE ANY DOCUMENTATION THAT A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER ALSO STATED THAT THERE WERE NO REPORTS TO THE RISK MANAGEMENT DEPARTMENT THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON HER REVIEW OF THE OPERATIVE REPORT, THE RISK MANAGER NOTED A STATEMENT THAT THE UTERINE ARTERY WAS BURNED OUT TOWARD THAT AREA AND WAS THEN EXCISED BY THE SURGEON. THE RISK MANAGER WAS UNABLE TO PROVIDE CLARIFICATION AS TO WHAT WAS MEANT BY THE UTERINE ARTERY WAS BURNED OUT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT ON (B)(4) 2013 INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND CYSTOSCOPY ON (B)(6) 2012 WITH A PRE-OPERATIVE DIAGNOSIS OF LARGE UTERINE FIBROID. 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 SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED. AT THE END OF THE SURGICAL PROCEDURE, THE ENTIRE SURGICAL AREA WAS INSPECTED FOR HEMOSTASIS AND THERE WAS NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. THE PATIENT WAS TRANSFERRED TO THE RECOVERY ROOM IN STABLE CONDITION. REPORTEDLY, THE PATIENT RECEIVED A BLOOD TRANSFUSION POST-OPERATIVELY. ON (B)(6) 2012 THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF VAGINAL BLEEDING AND CRAMPING. A PELVIC EXAMINATION FOUND THAT THE PATIENT WAS BLEEDING FROM THE VAGINAL CUFF APEX. THE AFFECTED AREA WAS SUTURED AND THE BLEEDING WAS NOTED TO HAVE CEASED AFTER THE REPAIR. THE PATIENT ALSO REQUIRED A BLOOD TRANSFUSION. THE PATIENT WAS DISCHARGED FROM THE HOSPI

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2012, AND ALLEGED TO HAVE INJURIES INCLUDING A BOWEL PERFORATION REQUIRING COLECTOMY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DAVINCI ROBOTIC BILATERAL SALPINGO-OOPHORECTOMY FOR BILATERAL DERMOID TUMORS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. THE PATIENT HAD PREVIOUSLY UNDERGONE ROBOTIC HYSTERECTOMY 13 MONTHS PRIOR AND NOW PELVIC PAIN PERSISTS. ON (B)(6) 2012 THE PATIENT UNDERWENT BILATERAL SALPINGO-OOPHORECTOMY. PER OPERATIVE REPORT, PK DISSECTING FORCEPS AND MONOPOLAR SCISSORS WERE USED. THE PATIENT WAS DISCHARGED HOME NEXT DAY IN STABLE CONDITION. ON (B)(6) 2012, THE PATIENT WAS READMITTED FOR ABRUPT FEVER AND CHILLS. SONOGRAM NOTED SMALL AMOUNT FLUID IN PELVIS. PATIENT UNDERWENT CYSTOSCOPY WITH ATTEMPTED RIGHT URETERAL STENT PLACEMENT. URINOMA WAS DISCOVERED. THE PROCEDURE WAS ABORTED SINCE SURGEON WAS UNABLE TO PLACE STENT. NEPHROSTOMY TUBE WAS PLACED. ON (B)(6) 2013, THE PATIENT SUBSEQUENTLY UNDERWENT RIGHT URETERAL RE-IMPLANT WITH PSOAS HITCH PROCEDURE THROUGH AN OPEN LAPAROTOMY APPROACH. THE PAT

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT EXPIRED APPROXIMATELY FOUR WEEKS AFTER AN ESOPHAGECTOMY PROCEDURE WAS PERFORMED. THE ROBOTICALLY-ASSISTED SURGERY WAS CONVERTED TO OPEN SURGICAL TECHNIQUES, AS IT WAS STATED TO HAVE BEEN DIFFICULT FOR A NUMBER OF REASONS, ACCORDING TO THE SURGEON. THE COMPANY REPRESENTATIVE WAS INFORMED THAT THE PATIENT WAS DISCHARGED THREE WEEKS AFTER THE PROCEDURE FOR REHABILITATION. THE PATIENT THEN DIED A WEEK LATER OF WHAT THE HOSPITAL STAFF BELIEVES TO BE DUE TO A PULMONARY EMBOLISM/OTHER CARDIORESPIRATORY RELATED EVENT. NO FURTHER INFORMATION WAS 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 SI THROAT SURGICAL PROCEDURE FOR SLEEP APNEA ON (B)(6) 2012. THE PATIENT REPORTEDLY DEVELOPED COGNITIVE ISSUES, WORSENED DEPRESSION, PROBLEMS WITH EATING AND CHOKING, AND FOOD TASTED TASTELESS FOLLOWING THE SURGICAL PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE UNDOCKING AFTER A DA VINCI S HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED CHARRING AT ONE OF THE PORT INCISION SITES. THE SURGEON EXCISED A SMALL AREA OF THE AFFECTED PORT SITE, SUTURE CLOSED THE INCISION AND APPLIED A DRY DRESSING. THE EXCISED SAMPLE WAS SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT TO BE ANALYZED. THE ROBOTICS COORDINATOR PRESENT DURING THE SURGICAL PROCEDURE INDICATED THAT THERE WAS NO HARM TO THE PATIENT DURING THE SURGICAL PROCEDURE AND THE SYSTEM DID NOT FAULT DURING THE PLANNED SURGICAL PROCEDURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY FOR ABNORMAL UTERINE BLEEDING WITH LARGE UTERINE FIBROIDS ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT AND THE EXPLORATORY LAPAROTOMY AND ICU DISCHARGE SUMMARY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE HYSTERECTOMY WAS PERFORMED WITH SEQUENTIAL COAGULATION AND DIVISION OF THE ROUND LIGAMENTS, UTERO-OVARIAN LIGAMENTS, BROAD LIGAMENTS, UTEROSACRAL LIGAMENTS AND UTERINE VESSELS. THE COLPOTOMY WAS COMPLETED, BUT THE UTERUS WAS TOO LARGE TO DELIVER VAGINALLY, SO IT WAS MORCELLATED WITH A HAND HELD MORCELLATOR UNTIL SMALL ENOUGH TO DELIVER. THE VAGINAL CUFF WAS CLOSED WITH V-LOC SUTURE AND ADDITIONAL MATERIAL USED TO SECURE ADEQUATE HEMOSTASIS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ON (B)(6) 2012, PATIENT PRESENTED WITH A HISTORY OF LOWER ABDOMINAL DISCOMFORT, NAUSEA AND CONSTIPATION. CT IMAGING SHOWED EXTENSIVE COMPLEX FLUID COLLECTION IN PELVIS AND PERICOLIC GUTTERS CONSISTENT WITH HEMATOMA OR ABSCESS. IN THE ED DARK PURULENT MATERIAL WAS DR

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: RIGHT URETER WAS CUT, URINE LEAKAGE INTO ABDOMINAL CAVITY, ABDOMINAL PAIN, AND STENTS IN HOLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. THE MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. BASED ON THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD A PREOPERATIVE DIAGNOSIS OF IRREGULAR BLEEDING AND PELVIC PAIN. ACCORDING TO THE OPERATIVE REPORT, THE DA VINCI SI HYSTERECTOMY PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS. AFTER THE PATIENT'S UTERUS, OVARIES, AND TUBES WERE REMOVED THROUGH THE VAGINA, THE VAGINAL CUFF WAS CLOSED WITH SUTURES AND CAREFUL INSPECTION REVEALED EXCELLENT HEMOSTASIS OF ALL PEDICLES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF ABDOMINAL PAIN, NAUSEA, AND VOMITING. THE PATIENT WAS SENT HOME THE SAME DAY AFTER NO SIGNS OF ACUTE INTRA-ABDOMINAL OR PELVIC ABSCESSES WERE FOUND. ON (B)(6) 2012, THE PATIENT WAS EVALUATED IN THE ER FOR REPORTED COMPLAINTS OF VAGINAL BLEEDING, NAUSEA, AND VOMITING. A CT SCAN PERFORMED ON THE PA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE ON (B)(6) 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: BLADDER WON'T STOP LEAKING, HAS HERNIA, SURGICAL CORRECTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISCOVERY ACTIVITY, ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE. ISI WAS PROVIDED WITH A COPY OF THE HOSPITAL'S RISK OCCURRENCE REPORT FROM THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT. THE RISK OCCURRENCE REPORT INDICATED THAT DURING THE SURGICAL PROCEDURE, THE PATIENT SUSTAINED A RIGHT URETER INJURY. THE SITE'S UROLOGIST ANASTOMOSED THE PATIENT'S URETER TO REPAIR THE DAMAGE USING THE DA VINCI SURGICAL SYSTEM. THE PATIENT ALSO UNDERWENT A CYSTOSCOPY PROCEDURE, AND A RIGHT URETERAL STENT PLACEMENT PROCEDURE. NO ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY ON (B)(6) 2012. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL RADIOLOGY 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) 2012, THE PATIENT WAS ADMITTED WITH NAUSEA, VOMITING, AND AN ILEUS. SHE HAD MULTIPLE DAYS OF FEVER AND WAS STARTED ON I.V. ANTIBIOTICS. ON (B)(6) 2012, SHE HAD A CT SCAN, WHICH NOTED A PELVIC FLUID COLLECTION AND ABSCESS. ON (B)(6) 2012, HER PELVIC ABSCESS WAS DRAINED. SHE THEN HAD DECREASED URINE OUTPUT AND THE DRAINING PELVIC FLUID WAS THOUGHT TO BE URINE (URINOMA). SUBSEQUENTLY, BILATERAL NEPHROSTOMY TUBES WERE PLACED AND THE PATIENT REMAINED IN THE HOSPITAL ON I.V. ANTIBIOTICS. THE PATIENT SLOWLY IMPROVED WITH A RESOLVED ILEUS. ON (B)(6) 2012, A RETROGRADE IVP SHOWED A SMALLER, BUT PERSISTENT, CYSTOTOMY. OVER THE NEXT WEEK, THE NEPHROSTOMY TUBES WERE REMOVED AND THE PATIENT WAS EVENTUALLY DISCHARGED. HAD PROLONGED URINAR