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 GYNECOLOGICAL PROCEDURE, THE PATIENT SUSTAINED AN INJURY TO HER URETER. REPORTEDLY, THE PATIENT REMAINED HOSPITALIZED AND IT IS UNKNOWN WHEN THE PATIENT WOULD BE DISCHARGED. ON (B)(6) 2013, INTUITIVE SURGICAL CONTACTED THE PHYSICIAN'S ASSISTANT (PA) WHO ASSISTED DURING THE SURGICAL PROCEDURE. THE PA INDICATED THAT THE DAMAGE TO THE PATIENT'S URETER WAS DISCOVERED SEVERAL DAYS POST OP WHILE THE PATIENT WAS STILL HOSPITALIZED. THE PA ALSO INDICATED THAT THE PATIENT ALSO DEVELOPED A FISTULA. THE PA DID NOT PROVIDE ANY OTHER INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: (B)(4) 2014: PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2013 FOR A PARTIAL HYSTERECTOMY. SURGERY WAS PERFORMED ON (B)(6) 2013. AFTER SURGERY PATIENT SHOULD HAVE AWAKENED AFTER APPROXIMATELY 3 HOURS. TEN HOURS FOLLOWING SURGERY PATIENT WAS PLACED IN ICU. DOCTORS EXPLAINED THAT MEDICATION CAUSED HER TO SLEEP LONGER. PATIENT WAS RELEASED FROM ICU THE FOLLOWING DAY. PATIENT NOTICED CLEAR LIQUID LEAKING FROM HER VAGINA AND SHE HAD TROUBLE BREATHING. SHE SAW DIFFERENT DOCTORS 3 TIMES AND THEN FINALLY WENT TO THE EMERGENCY ROOM. CT SCAN SHOWED SHE HAD PNEUMONIA AND WAS PLACED ON ANTIBIOTICS. FIVE DAYS LATER SHE STILL HAD LEAKING AND TROUBLE BREATHING SO SHE WENT TO A DIFFERENT EMERGENCY ROOM. CT SCAN SHOWED DURING THE ORIGINAL SURGERY THE DOCTOR CUT THE URETER. ONCOLOGIST RECOMMENDED THAT SHE CONTACT HER ORIGINAL SURGEON. SHE HAS APPREHENSIONS ABOUT IT BECAUSE HE MESSED UP THE ORIGINAL SURGERY. HER SURGERY IS SCHEDULED FOR NEXT MONTH. SHE HAS LOST HER JOB BECAUSE OF COMPLICATIONS FROM HER SURGERY. SHE HAS NO MEDICAL INSURANCE AND IS LOOKING INTO BRINGING SUIT. IT HAS BEEN ABOUT A YEAR AN

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 WHO UNDERWENT A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2013, EXPIRED POST-OPERATIVELY. A SURGEON WHO WAS PART OF THE CARDIAC TEAM AT THE SITE INFORMED AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT THE SURGICAL PROCEDURE WAS ABANDONED SINCE THE PATIENT DEVELOPED PULMONARY EDEMA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PROCEDURE OR ABOUT THE PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, WHILE PERFORMING SUTURE, THE SURGEON SEWED INTO THE PATIENT'S BLADDER, WHICH CREATED A HOLE IN THE PATIENT'S BLADDER. THE PATIENT'S BLADDER WAS REPAIRED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. CONTACTED THE PHYSICIAN'S ASSISTANT (PA) THAT WAS ASSISTING DURING THE DA VINCI SURGICAL PROCEDURE. THE PA INDICATED THAT AFTER THE SURGEON HAD COMPLETED CLOSURE OF THE PATIENT'S VAGINAL CUFF AND AFTER THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT, A CYSTOSCOPY PERFORMED ON THE PATIENT FOUND THAT THE SURGEON HAD INADVERTENTLY SUTURED THE PATIENT'S BLADDER DURING CLOSURE OF THE PATIENT'S VAGINAL CUFF. THE DA VINCI SURGICAL SYSTEM WAS RE-DOCKED TO THE PATIENT AND THE SURGEON REMOVED THE SUTURE FROM THE PATIENT'S BLADDER AND RE-SUTURED THE PATIENT'S VAGINAL CUFF TO CORRECT THE MISPLACED SUTURE. NO REPAIR TO THE PATIENT'S BLADDER WAS REQUIRED. THE PA INDICATED THAT NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED DURING THE SURGICAL PROCEDURE AND THAT INADVERTENT SUTURE OF THE PATIENT'S BLADDER BY THE SURGEON WAS DUE TO 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: IT WAS REPORTED THAT DURING A DA VINCI SI THORACIC PROCEDURE, THE PATIENT EXPIRED. REPORTEDLY, PRIOR TO THE PATIENT'S DEMISE, WHILE THE SURGEON WAS MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CONSOLE, THE SURGEON WAS UNABLE TO CONTROL OR MOVE THE INSTRUMENT INSTALLED ON A PATIENT SIDE MANIPULATOR (PSM) ARM 1. REPORTEDLY, THE SITE OBSERVED THAT THE LED ON PSM 1 WAS SOLID BLUE IN COLOR WHEN THE ISSUE OCCURRED AND THEY WERE EVENTUALLY ABLE TO RESOLVE THE ISSUE. ON (B)(6) 2013, INTUITIVE SURGICAL CONTACTED THE SURGEON WHO PERFORMED THE SURGICAL PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT'S DEMISE WAS UNRELATED TO HIS INABILITY TO MANIPULATE THE INSTRUMENT INSTALLED ON PSM 1, BUT RATHER THE PATIENT'S CONDITION. THE PATIENT WAS VERY SICK AND WAS NOT DOING VERY WELL UNDER ANESTHESIA. THE SURGEON INDICATED THAT HE HAD INTENDED TO PERFORM LUNG DECORT USING THE DA VINCI SURGICAL SYSTEM; HOWEVER, AFTER THE SYSTEM WAS DOCKED TO THE PATIENT AND WHEN HE SAT DOWN AT THE SSC, HE WAS UNABLE TO MOVE THE INSTRUMENT THAT WAS INSTALLED ON THE PSM. THE PATIENT HAD CHEST ADHESIONS AND AS A RESULT HE HAD TO CREATE LARGER PORT SITE INCISIONS. HE DID NOT OBSERVE ANY RESTRICTIO

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 NISSEN FUNDOPLICATION PROCEDURE, AFTER THE SURGEON COMPLETED SUTURING, THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS RELATED TO A PULMONARY EMBOLISM AND THAT THE PATIENT'S DEMISE WAS UNRELATED TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. IT IS BELIEVED THAT THE PATIENT EXPERIENCED COMPLICATIONS TO BLEEDING. 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: 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 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 — 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-OP A DA VINCI MYOMECTOMY PROCEDURE, THE PATIENT CODED. THE SITE ATTEMPTED TO RESUSCITATE THE PATIENT; HOWEVER, THE ATTEMPTS WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2013, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE WHO WAS MADE AWARE OF THIS INCIDENT, INDICATED THAT SHE WAS AT A GATHERING WHEN THIS INFORMATION WAS TOLD TO HER BY A SCRUB TECHNICIAN WHO WAS ASKED TO ASSIST WITH RESUSCITATION OF THE PATIENT. REPORTEDLY, THE DA VINCI SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT WHEN THE PATIENT BEGAN TO CODE. THE PATIENT HAD A PULMONARY EMBOLISM. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM. ON (B)(6) 2013, ISI CONTACTED THE SITE TO GATHER ADDITIONAL INFORMATION. THE SITE'S RISK MANAGER INDICATED THAT THEY HAD NO RECORD OF A PATIENT DEATH RELATED TO A DA VINCI SURGICAL PROCEDURE AS THEY DO NOT HAVE A DA VINCI SURGICAL SYSTEM AND THAT THE INITIAL REPORTER OF THE INCIDENT WAS NO LONGER AN EMPLOYEE OF THE HOSPITAL.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR MENORRHAGIA AND UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT AND MEDICAL RECORDS RELATED TO A CYSTOSCOPY AND RETROGRADE PYELOGRAPHY. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT AND/OR ACCESSORY DURING SURGERY. ACCORDING TO THE DA VINCI OPERATIVE REPORT DATED (B)(6) 2013, THE PROCEDURE WAS NOTED TO BE AN EXTREMELY COMPLICATED CASE, WHICH TOOK ABOUT 4 HOURS AND AS NOTED TO TAKE 2-4 TIMES LONGER THAN NORMAL. THE PATIENT NOTABLY HAD A LARGE UTERUS THAT WEIGHED 650 GRAMS. SHE HAD 2 PREVIOUS C-SECTIONS, WHICH CAUSED SCARRING. THE PATIENT'S URETERS WERE UNDERNEATH A LOT OF SCAR TISSUE; THEREFORE, A CYSTOSCOPY WAS ALSO DONE BECAUSE OF THE COMPLICATED NATURE OF THE PROCEDURE, LYSIS OF SEVERE ADHESIONS WAS DONE AS THE PREVIOUS SURGEON WHO TRIED TO DO HER CHOLECYSTECTOMY COULD NOT EVEN GET INTO HER ABDOMINAL CAVITY. THE SURGEON WAS ABLE TO GET INTO THE PATIENT'S ABDOMINAL CAVITY AND LYSED THESE ADHESIONS. THE RIGHT SIDE OF THE PATIENT'S UTERUS WAS STUCK IN A LOT OF SCAR T

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: ROBOT NICKED BLADDER AND URETER, HAD TO INSERT STENTS TO THE URETER TO HEAL HOLE. WOUND UP HAVING BLADDER SPASMS AND BLEEDING, HAD TO HAVE ANOTHER REMOVE STENTS. NOW HAS AN INCONTINENCE AND BLADDER SPASM

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 TOTAL HYSTERECTOMY, LEFT SALPINGECTOMY, CYSTOSCOPY AND EXTENSIVE LYSIS OF ADHESIONS FOR MENORRHAGIA, FIBROID UTERUS, PELVIC PAIN AND ANEMIA ON (B)(6) 2013. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT, THE REPORT FROM A CT UROGRAM, AND THE PROCEDURE NOTE FOR THE LATER PLACING OF A STENT. DURING THE PRIMARY SURGICAL PROCEDURE, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. THE OPERATIVE NOTE INDICATED THAT THERE WERE EXTENSIVE DENSE ADHESIONS INVOLVING THE ANTERIOR ABDOMINAL WALL, OMENTUM, BOWEL AND RIGHT TUBE AND OVARY (PATIENT HAD H/O RIGHT SALPINGECTOMY). A MONOPOLAR CURVED SCISSORS INSTRUMENT, MARYLAND DISSECTOR INSTRUMENT AND PROGRASP FORCEPS INSTRUMENT WERE USED TO SEQUENTIALLY COAGULATE WITH BIPOLAR AND EXCISE THE ROUND, BROAD AND UTERO-OVARIAN LIGAMENTS. THE COLPOTOMY WAS MADE AGAINST A KOH CUP. SHARP KNIFE MORCELLATION WAS REQUIRED TO REMOVE THE UTERUS THROUGH THE VAGINA, AND IT WAS NOTED THAT THE ENTIRE PROCEDURE WAS EXTREMELY DIFFICULT DUE TO THE EXTREMELY LARGE SIZE OF THE UTERUS 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 2 DAYS POST A SUCCESSFUL DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE PATIENT WAS TAKEN BACK INTO THE OR PRESENTING SYMPTOMS OF PAIN. IT WAS DISCOVERED THAT THE PATIENT HAD SUSTAINED A LACERATION OF THE SMALL BOWEL. REPORTEDLY, THE PATIENT WAS RELEASED FROM THE HOSPITAL AND IS RECOVERING FINE.

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 NISSEN FUNDOPLICATION PROCEDURE, ONE OF THE PATIENT'S VESSELS WAS COMPROMISED WHILE THE SURGEON WAS PERFORMING HIS LAST STITCH. THE BLEEDING WAS SECURED AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES. THE PATIENT SUBSEQUENTLY EXPIRED IN THE OPERATING ROOM DUE TO BLOOD LOSS AND PRE-EXISTING CONDITIONS.

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 SURGICAL PROCEDURE, THE SURGEON ENCOUNTERED A RECOVERABLE FAULT WHILE USING THE VESSEL SEALER INSTRUMENT. THE INITIAL REPORTER (ROBOTICS COORDINATOR) OF THIS COMPLAINT CONTACTED AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. HOWEVER, DURING THE CALL, THE ROBOTICS COORDINATOR DID NOT HAVE TIME TO TROUBLESHOOT. THE ROBOTICS COORDINATOR INDICATED THAT THE SURGEON CHOSE TO CONVERT THE DA VINCI SURGICAL PROCEDURE TO TRADITIONAL LAPAROSCOPIC TECHNIQUES. INITIALLY, NO PATIENT HARM, ADVERSE OUTCOME, OR INJURY WAS REPORTED. THE TSE REVIEWED THE SITE'S SYSTEM LOGS AND FOUND AN ERROR 32001 RELATED TO THE VESSEL SEALER INSTRUMENT. AN ERROR 32001 INDICATES THAT THE VESSEL SEAL INSTRUMENT CUTTING BLADE CANNOT BE RETRACTED AND MAY BE EXPOSED.

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 COMPLETION OF A DA VINCI SI MYOMECTOMY PROCEDURE, WHILE UNDOCKING THE SYSTEM FROM THE PATIENT, THE PATIENT REQUIRED RESUSCITATION. THE ANESTHESIOLOGIST PERFORMED CHEST COMPRESSIONS ON THE PATIENT; HOWEVER, THE RESUSCITATION ATTEMPTS FAILED AND THE PATIENT EXPIRED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6) FEMALE UNDERGOING A ROBOTIC MYOMECTOMY AND BILATERAL NEOSALPINGOSTOMY HAD AN INTRAOPERATIVE DEATH. NEAR THE END OF THE PROCEDURE, THE PT'S BLOOD PRESSURE WAS NOT DETECTED IN THE PRESENCE OF A PULSE AND NORMAL OXYGENATION LEVELS. THE RHYTHM WAS NOTED TO BE PULSELESS ELECTRICAL ACTIVITY (PEA). DESPITE ACLS PROCEDURES AND AN ATTEMPT TO INSERT AN INTRA-AORTIC BALLOON PUMP TO SUSTAIN THE PT, ALL RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. RESUSCITATIVE EFFORTS WERE SUSTAINED FOR OVER 2 HRS AT NO TIME WAS A PROBLEM WITH THE ROBOTIC EQUIPMENT REPORTED. THIS WAS AN UNEXPECTED DEATH. PROVISIONAL AUTOPSY RESULTS: AV SEPTUM REVEALED AN AREA OF BLEEDING AND FATTY INFILTRATION. THERE WAS FATTY INFILTRATION OF THE LIVER. HOWEVER, IN THE ABSENCE OF OTHER FINDINGS, DEFINITIVE CHARACTERIZATIONS FOR THE CAUSE OF THE ARRHYTHMIA AND LEFT VENTRICULAR FAILURE IS NOT POSSIBLE. THE FINAL RESULTS ARE STILL PENDING.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, THE SURGEON CUT ONE OR MORE UNSPECIFIED ARTERIES WHILE ATTEMPTING TO REMOVE LYMPH NODES. ACCORDING TO THE PATIENT, AFTER THE UTERUS, OVARIES, AND FALLOPIAN TUBES WERE REMOVED, THE SURGEON WENT BACK IN TO REMOVE THE LYMPH NODES ON THE RIGHT SIDE. THE PATIENT STATED THAT AS THE LYMPH NODES WERE BEING REMOVED, ARTERIES ATTACHED TO THE LYMPH NODES WERE CUT IN TWO UNSPECIFIED PLACES. A TOTAL OF 14 LYMPH NODES WERE REMOVED. THE SURGEON ATTEMPTED UNSUCCESSFULLY TO REPAIR THE ARTERIES USING THE DA VINCI SURGICAL SYSTEM. A VASCULAR SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGERY IN ORDER TO REPAIR THE VESSELS. A BLOOD TRANSFUSION WAS ADMINISTERED AND 4 UNITS OF BLOOD WERE GIVEN. THE SURGICAL PROCEDURE TOOK 10 HOURS TO COMPLETE. THE PATIENT INDICATED THAT SHE WAS IN THE ICU FOR EIGHT DAYS POST-OPERATIVELY. IV FLUIDS WERE ADMINISTERED WHICH CAUSED SEVERE BLOATING. AN UNSPECIFIED MEDICATION WAS THEN ADMINISTERED TO ASSIST THE PATIENT WITH FLUID ELIMINATION TO MINIMIZE THE BLOATING. AT AN UNSPECIFIED TIME POST-OPERATIVELY, THE PATIENT INDICATED THAT SHE WENT INTO ATRIAL FIBRILLATION. UPON DISCHARGE FROM THE HOSPITAL, THE PATIEN

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) 2012, DR (B)(6) PERFORMED SURGERY OF THE REMOVAL OF MY LEFT OVARY. THE DA VINCI ROBOTIC ASSIST THE SURGEON. SOON AFTER SURGERY, I BECAME VERY ILL WITH SURGICAL MENOPAUSE. AFTER I REQUESTED A U.S./PELVIC TRANSVAGINAL ULTRASOUND, IT WAS DISCOVERED THE RIGHT OVARY IS NOT IDENTIFIED. IT WAS REMOVED IN ERROR DURING SURGERY.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE WITH BILATERAL URETEROLYSIS AND LYSIS OF SEVERE ADHESIONS FOR HIGH RISK UTERINE CANCER (B)(6) 2013. ACCORDING TO THE LEGAL DOCUMENT PROVIDED, THE PATIENT SUSTAINED A SMALL BOWEL PERFORATION, DEVELOPED NECROTIZING FASCIITIS, AND SUBSEQUENTLY PASSED AWAY. ISI WAS PROVIDED WITH THE OPERATIVE REPORT OR THE PATIENT'S MEDICAL RECORDS. POST-OPERATIVELY, THE PATIENT'S ABDOMEN WAS FOUND TO BE SOFT AND BOWEL SOUNDS WERE PRESENT. NO DISTENTION WAS OBSERVED. THE PATIENT WAS ABLE TO AMBULATE, TOLERATE A REGULAR DIET, AND VOID. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED. ON (B)(6) 2013, THE PATIENT WAS ADMITTED WITH WORSENING ABDOMINAL PAIN, SOMNOLENCE, AND ANOREXIA. THE PATIENT WAS FOUND TO BE TACHYCARDIC, HYPOTENSIVE, AND HYPOXIC. THE PATIENT'S WHITE BLOOD CELL COUNT WAS 5.9 WITH 92% BANDS. A CT SCAN SHOWED FREE INTRAPERITONEAL AIR AND FREE AIR ALONG THE ENTIRE LEFT SIDE OF THE ABDOMEN. THE PATIENT WAS TAKEN URGENTLY TO THE OPERATING ROOM AND AN EXPLORATORY LAPAROTOMY WAS PERFORMED. ADHESIONS OF THE SMALL BOWEL TO THE ANTERIOR ABDOMINAL WALL WERE 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: IT WAS REPORTED THAT DURING A DA VINCI SI CHOLECYSTECTOMY PROCEDURE, THE CANNULA MOUNT ON THE PATIENT SIDE MANIPULATOR (PSM) ARM WOULD NOT STAY CLOSED. IT WAS ALSO REPORTED THAT THE PATIENT'S GALLBLADDER, WHICH WAS TO BE REMOVED AS PART OF THE SURGICAL PROCEDURE WAS NICKED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED; HOWEVER; DUE TO THE CANNULA MOUNT NOT STAYING CLOSED, THE SURGICAL TIME WAS LENGTHENED APPROXIMATELY 2 HOURS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: (B)(6) 2013 - DA VINCI ROBOTIC HYSTERECTOMY. (B)(6) - BACK TO WORK. SEVERE PAIN, CONTINUED SEVERE PAIN. SURGEON'S OFFICE TOLD ME TO SEE UROLOGIST. LAB WORK POSITIVE FOR E COLI AND PSEUDOMONAS AERUGINOSA. FOR MONTHS FOLLOWING CONTINUED PAIN/SEVERE. INFECTIOUS DISEASE DOCTOR - POSITIVE INFECTIONS. (B)(6) 2013 NEUROLOGIST: ABNORMAL EMG - MRI'S ABNORMAL. LEFT HIP LABRUM TEAR - MULTIPLE DISC HERNIATIONS. DR (B)(6) REFERRED TO PAIN MANAGEMENT NEUROLOGIST AT (B)(4) - NERVE BLOCK INJECTIONS. CONCLUSIONS: ILIOINGUINAL NERVE ENTRAPMENT DAMAGE/INJURY. GENITAL FEMORAL NERVE DAMAGE/ENTRAPMENT/COMPRESSION INJURY. THIS ROBOTIC DA VINCI SURGERY HAS LEFT MY BODY IN DISASTROUS PAIN EVERYWHERE. MY INSIDE/INTERNAL BODY BURNS AND IN SEVERE PAIN EVERYWHERE INCLUDING SURGICAL SITE, GENITALIA, RECTAL, ARMS, SHOULDERS. WEAKNESS AND BURNING SENSATION. THIS HAS BEEN CATASTROPHIC AND DEVASTATING. IT IS ALSO KNOWN (I NOW KNOW) THAT CERTAIN BODY TYPES ARE NOT GOOD CANDIDATES FOR ROBOTIC. I AM VERY SLENDER AND RETRACTORS TOO LARGE FOR MY BODY. ALSO POSITIONING FOR GYNECOLOGICAL SURGERIES IS DANGEROUS CAUSING INJURIES OR FATALITIES. TRENDELENBURG AND LITHOTOMY POSITIONS ARE SERIOUSLY DANGEROUS. DA VINCI ROBOTIC H

At approximately 12:50 a.m. on June 16, 2013, Employee #1 was working in a maintenance crew replacing a gear reducer and gaskets on an articulating robot. Employee #1 walked under the axis arm of the robot at the same time the arm, along with axes and welding tooling, mounted at the end of axis arm. The arm pivoted around the axis and collapsed into another axis arm, perpendicular to the floor. Employee #1 was caught between the tooling axis arms and the robot. Employee #1 was taken to the hospital with multiple blunt force injuries, where he later died.

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, WITH THE USE OF DUAL SURGEON SIDE CONSOLES (SSCS), DURING DISSECTION THE PATIENT'S URETHRA, THE SURGEON EXPERIENCED RESISTANCE ON PATIENT SIDE MANIPULATOR (PSM) ARMS 1 AND 2 WHILE MANIPULATING THE MASTER TOOL MANIPULATORS (MTMS) ON THE SURGEON SIDE CARTS (SSC). THE SURGEON CONTINUED TO MANIPULATE THE MTMS WHEN PSM 1 SUDDENLY MOVED, CAUSING THE INSTALLED MONOPOLAR CURVED SCISSORS INSTRUMENT TO CUT THE PATIENT'S URETHRA. THE SURGEON RECONSTRUCTED THE AFFECTED AREA TO REPAIR THE DAMAGE TO THE PATIENT'S URETHRA AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE DA VINCI 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 DURING A DA VINCI SURGICAL SI HYSTERECTOMY PROCEDURE, THE PATIENT SUSTAINED A THERMAL INJURY TO THE URETER. 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY ON (B)(6) 2013 FOR A HISTORY OF PELVIC PAIN DYSMENORRHEA AND MENORRHAGIA. ISI WAS PROVIDED WITH THE OPERATIVE REPORT FOR BOTH THE PRIMARY SURGERIES AND THE VAGINAL VAULT REPAIR. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE PATIENT WAS NOTABLE FOR ADHESIONS OVER THE ANTERIOR UTERINE VESICLE FOLD FROM PREVIOUS C-SECTIONS. THE HYSTERECTOMY PROCEEDED WITH SEQUENTIAL CAUTERY AND TRANSECTION OF THE UTERO-OVARIAN LIGAMENTS, ROUND LIGAMENT, BROAD LIGAMENTS AND UTERINE ARTERY. THE COLPOTOMY WAS PERFORMED WITH MONOPOLAR SCISSORS AND PK FORCEPS, THE UTEROSACRAL LIGAMENTS DESICCATED AND TRANSECTED, AND THE SPECIMEN DELIVERED THROUGH THE VAGINA. THE VAGINA WAS CLOSED WITH QUILL SUTURE. THE SURGERY WAS COMPLETED WITHOUT COMPLICATION. THE PATIENT HAD AN UNREMARKABLE POST OPERATIVE COURSE WITH A VAGINAL EXAM AT 4-5 WEEKS SHOWING THE VAGINAL CUFF HEALING NICELY. ON (B)(6) 2013, THE PATIENT PRESENTED TO THE ED WITH SEVERE LOWER ABDOMINAL DISCOMFORT AF

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR UTERINE FIBROIDS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT, FOLLOW-UP OPERATIVE REPORTS AND DOCUMENTATION REGARDING URETERAL INJURY. 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 DA VINCI SURGICAL PROCEDURE. ON (B)(6) 2013, PATIENT PRESENTED WITH SYMPTOMS OF ABDOMINAL PAIN AND UNDERWENT A CT SCAN WHICH DEMONSTRATED PARTIAL URETERAL OBSTRUCTION. ON (B)(6) 2013, THE PATIENT UNDERWENT A CYSTOSCOPY WITH PASSAGE OF A STENT. A PARTIAL TRANSECTION OF THE URETER IS SUSPECTED. A URETERAL RE-IMPLANTATION IS PLANNED. 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 A PATIENT UNDERWENT A DA VINCI SI HYSTERECTOMY SURGICAL PROCEDURE AND SUSTAINED A BOWEL INJURY. INTUITIVE SURGICAL INC. (ISI) SPOKE TO THE PATIENT ON (B)(4) 2013 AND OBTAINED THE FOLLOWING INFORMATION: ON (B)(6) 2013, THE PATIENT UNDERWENT A HYSTERECTOMY PROCEDURE USING A DA VINCI SI SYSTEM. ON (B)(6) 2013, THE PATIENT DEVELOPED SHARP ABDOMINAL PAINS AND ALSO EXPERIENCED GAS LIKE SYMPTOMS. SHE CONTACTED HER SURGEON AND WAS ADVISED TO TAKE GAS MEDICATION FOR HER SYMPTOMS. ON (B)(6) 2013 AROUND 5:30-6:00PM, HER SYMPTOMS PROGRESSIVELY GOT WORSE, HAD A FEVER OF 102 AND WAS TAKEN TO THE HOSPITAL BY PARAMEDICS. ON (B)(6) 2013, THE PATIENT WENT IN FOR AN X- RAY AND IT WAS DISCOVERED THAT THE PATIENT HAD A CUT BOWEL. THE PATIENT WENT IN FOR SURGERY TO REPAIR HER CUT BOWEL AND IT WAS ALSO DISCOVERED THAT PATIENT HAD AN ABSCESS. THE PATIENT WAS ADMITTED IN THE HOSPITAL FOR 14 DAYS FOR AN INFECTION AND RECOVERY OF THE CUT BOWEL. NO FURTHER INFORMATION WAS PROVIDED BY THE PATIENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT 2 DAYS POST OP A SUCCESSFUL DA VINCI SI LEFT SALPINGO-OOPHORECTOMY PROCEDURE, PERFORMED ON (B)(6) 2013, THE PATIENT RETURNED TO THE HOSPITAL'S EMERGENCY ROOM ON (B)(6) 2013 WITH SYMPTOMS OF ABDOMINAL PAIN. THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY AND IT WAS DISCOVERED THAT THE PATIENT HAD FREE AIR IN HER ABDOMEN AND HER SIGMOID COLON WAS DAMAGED AT THE SITE OF DISSECTION DURING THE INITIAL 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: IT WAS REPORTED THAT DURING A DA VINCI S MITRAL VALVE REPAIR PROCEDURE, THE INSTRUMENT INSTALLED ON PATIENT SIDE MANIPULATOR (PSM) ARM 1 WAS NOT ROTATING. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THE SITE INSTALLED DIFFERENT INSTRUMENTS AND RESEATED THE STERILE ADAPTER, HOWEVER, THE ISSUE PERSISTED. THE SITE INDICATED THAT THE SURGEON ENCOUNTERED THE ISSUE EVERY TIME HE CHANGED PSMS. THE SITE ADVISED THE TSE THAT THEY WERE CONTINUING WITH THE CASE. APPROXIMATELY 1 HOUR LATER, THE SITE CALLED ISI BACK FOR TECHNICAL SUPPORT ASSISTANCE. THE SITE INDICATED TO THE TSE THAT THE SYSTEM WAS NOT WORKING CORRECTLY AND THAT THE PSM WAS SHAKING. THE SITE DECLINED TO TROUBLESHOOT THE ISSUE WITH THE TSE, AS THEY WERE IN THE MIDDLE OF THE PROCEDURE. THE SITE REQUESTED THAT THE TSE DISPATCH AN ISI FIELD SERVICE ENGINEER TO EVALUATE THE 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BSO FOR COMPLEX ADNEXAL MASS ON (B)(6) 2013. THE ATTORNEY REPRESENTING THE PATIENT ALLEGED THAT THE PATIENT SUFFERED AN UNSPECIFIED MISCELLANEOUS INJURY. THE PATIENT HAD DENSE ADHESIONS. APPARENTLY THERE WAS A MALFUNCTION OF A PK INSTRUMENT WHICH DID NOT ALLOW IT TO FIRE; HOWEVER, OTHER INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE WITHOUT ANY EFFECT ON THE PROCEDURE OR THE PATIENT. NO MEDICAL RECORDS AFTER (B)(6) 2013 WERE 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) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: URETER WAS CUT, INFECTION (HAD TO BE PUT ON ANTIBIOTICS), SURGICAL CORRECTION.

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 FEW DAYS POST OP A DA VINCI SI ENDOMETRIOSIS RESECTION PROCEDURE, PERFORMED ON (B)(6) 2013, THE PATIENT EXPIRED AT HOME. DURING THE SURGICAL PROCEDURE, EXTENSIVE RESECTION WAS COMPLETED ON THE PATIENT'S LEFT PELVIS SURROUNDING THE URETER AND COLON.

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)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY 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 POST-OP FROM THE DA VINCI SURGICAL PROCEDURE, THE PATIENT WAS TAKEN BACK INTO SURGERY TO UNDERGO A URETER STENT PLACEMENT AND URETER REPAIR 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 MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI)RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE AND HAD A PUNCTURED BLADDER ON (B)(6) 2013. NO FURTHER INFORMATION IS 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 PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF INDICATED THAT THE PATIENT SIDE MANIPULATOR (PSM1) ARM 1 MOVED INADVERTENTLY AND THE PATIENT SUSTAINED A BOWEL INJURY. THE SURGEON REPAIRED THE BOWEL INJURY AND THE SURGICAL PROCEDURE WAS COMPLETED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE PATIENT SUSTAINED A URETERAL INJURY THAT WAS DUE TO SURGEON ERROR AND NOT AN ISSUE WITH AN INSTRUMENT.

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 SEVERAL DAYS POST A DA VINCI SINGLE SITE CHOLECYSTECTOMY PROCEDURE THE PATIENT EXPIRED AT HOME.

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: DAMAGED HER BLADDER, A LOT OF PAIN FROM SURGERY, INCONTINENCE, BOWEL PROBLEMS, HAS TO WEAR DIAPERS.

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 TRANSECTED. AT THE END OF THE HYSTERECTOMY PROCEDURE, THE SURGEON HAD PERFORMED A CYSTOSCOPY AND CONSULTED WITH UROLOGY RESIDENTS TO VERIFY THAT THE PATIENT HAD NOT BEEN HARMED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT POST OP A DAVINCI SI GYNECOLOGICAL PROCEDURE, THE PATIENT EXPIRED DUE TO SEPSIS AS RESULT OF A SUSPECTED BOWEL 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 DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE PATIENT SIDE MANIPULATOR (PSM) ARM 1 ALLEGEDLY JUMPED AND ONE OF THE PATIENT'S ARTERIES WAS NICKED BY THE INSTRUMENT INSTALLED ON PSM 1.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC ARM #1 WITH MONOPOLAR CURVED SCISSORS JUMPED FORWARD AND NICKED A VESSEL DURING SURGICAL INTERVENTION. CLIPS WERE SUCCESSFULLY APPLIED TO CONTROL THE BLEEDING VESSEL. AN ADD'L MONOPOLAR CURVED SCISSORS JAMMED DURING THIS PROCEDURE. REASON FOR USE: LAPAROSCOPIC ROBOTIC SUPRACERVICAL HYSTERECTOMY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI SI SACROCOLPOPEXY PROCEDURE, THE SURGEON INDICATED THAT THE RIGHT PATIENT SIDE MANIPULATOR (PSM) ON THE PATIENT SIDE CART (PSC) INADVERTENTLY MOVED AND THE PATIENT'S BOWEL/COLON WAS PIERCED. AT THE TIME THAT THE INJURY OCCURRED, THE PSC WAS DOCKED TO THE PATIENT AND INSTRUMENTS WERE INSERTED. THE SURGEON INDICATED THAT WHEN SHE REACHED FOR THE MASTER TOOL MANIPULATORS (MTM), THE RIGHT PSM MOVED WITHOUT HER INPUT. THE PATIENT'S BOWEL WAS REPAIRED VIA SUTURING AND THE SURGICAL PROCEDURE WAS COMPLETED WITH THE DA VINCI SI 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: ON (B)(6) 2013, INTUITIVE SURGICAL, INC. RECEIVED A VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING DESCRIPTION: HOSPITALIZED AS AN INPATIENT FROM (B)(6) 2013, INFECTION CONTINUE TO HAVE UNEXPLAINED ABDOMINAL PAIN AND DEHISCENCE OF VAGINAL CUFF/INFECTION. HAD ROBOTIC SURGERY THAT ENDED UP WITH INFECTION, CUT THROUGH NERVE AND SIGMOID COLON BOWEL RESECTION. INITIAL SURGERY WAS SUPPOSED TO HAVE BEEN TOTAL VAGINAL HYSTERECTOMY WITH DA VINCI ROBOT. DIAGNOSIS OR REASON FOR USE: HYSTERECTOMY FOR ANDENO CARCINOMA. USED AT (B)(4) MEDICAL CENTER. RE- HOSPITALIZED FOR INFECTION DEHISCENCE OF WOUND SIGMOID COLON RESECTION. PATIENT AND HOSPITAL INFORMATION NAMES WERE NOT PROVIDED WITH THE VOLUNTARY REPORT; THEREFORE, ISI IS UNABLE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT AT THIS TIME.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI NEPHRECTOMY PROCEDURE FOR A LEFT RENAL MASS ON (B)(6) 2013. 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. NO OPERATIVE COMPLICATIONS WERE NOTED AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 50 ML. POST-OPERATIVELY, THE PATIENT WAS DOING FINE UNTIL THE MORNING OF (B)(6) 2013 WHEN HER HEMOGLOBIN WAS FOUND TO HAVE DROPPED FROM 7.8 TO 5.5, AND SHE SUBSEQUENTLY BECAME HYPOTENSIVE. HER ANTICOAGULATION, WHICH SHE HAD BEEN ON FOR HER ATRIAL FIBRILLATION, WAS STOPPED. A CT SCAN WAS PERFORMED AND SHOWED AN ANTERIOR WALL HEMATOMA AS WELL AS A HEMATOMA IN THE SURGICAL BED. SELECTIVE EMBOLIZATION WAS UNDERTAKEN OF THE INTERNAL MAMMARY ARTERY, AND THE PATIENT WAS TRANSFERRED BACK TO THE FLOOR AND RECEIVED FOUR UNITS OF PACKED CELLS. SHE INITIALLY RESPONDED, BUT AFTER MIDNIGHT ON (B)(6) 2013 SHE BECAME ACUTELY MORE HYPOTENSIVE AND HER URINE OUTPUT DECREASED. SHE WAS TRANSFERRED TO THE SURGICAL ICU FOR FURTHER EVALUATIO

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC., (ISI) RECEIVED INFORMATION OF A PATIENT WHO UNDERWENT A DA VINCI SI BARIATRIC BAND SURGICAL PROCEDURE ON (B)(6) 2013. THE PATIENT WAS ADVISED AFTER THE DA VINCI SURGERY THAT THERE WAS A LEAK THAT NEEDED TO BE FIXED. APPROXIMATELY ON (B)(6) 2013, ANOTHER SURGERY WAS PERFORMED TO DRAIN THE PATIENT'S BODY CAVITY (10 LITERS WERE REMOVED). ON AN UNSPECIFIED DATE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT, WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE, SUSTAINED AN UNSPECIFIED BOWEL 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR SEVERE DYSMENORRHEA, MENORRHAGIA AND UTERINE FIBROIDS ON (B)(6) 2013. 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 RECEIVED 4 UNITS OF PACKED RED BLOOD CELLS PRIOR TO SURGERY. THE UTERUS WAS 12-14 CM IN SIZE AND GOOD CLOSURE OF THE VAGINAL CUFF WAS REPORTED AS GOOD. INSPECTION OF THE PELVIS REVEALED NO EVIDENCE OF BLEEDING. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION. BLOOD LOSS WAS APPROXIMATELY 125ML. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY, FOR A 2 DAY HOSPITAL STAY. ON (B)(6) 2013 THE PATIENT PRESENTED WITH PERSISTENT NAUSEA AND BILIOUS VOMITING. THE PATIENT REPORTED CRAMPING AND ABDOMINAL PAIN IN ADDITION TO ABDOMINAL GURGLING. A CT SCAN FOUND MULTIPLE MODERATELY DILATED FLUID FILLED SMALL BOWEL LOOPS AND MINIMAL BILATERAL PLEURAL EFFUSIONS WITH MILD BIBASILAR ATELECT

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI S PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION FOR ADENOCARCINOMA OF THE PROSTATE ON (B)(6) 2013. ISI WAS PROVIDED WITH THE PATIENT'S OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES THE PATIENT'S SECONDARY ADMISSION FOR SEPSIS AND DISCHARGE SUMMARY. IN THE PRIMARY SURGERY, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING THE SURGERY. AFTER ENTRY AND INSPECTION, THE DISTAL PERITONEUM WAS TAKEN DOWN, THE VAS DEFERENS, TRANSECTED, THE SEMINAL VESICLE DISSECTED FREE USING CLIPS AND SHARP DISSECTION. THE ANTERIOR BLADDER FLAP WAS CREATED, THE DORSAL VEIN COMPLEX SUTURED, AND THE NEUROVASCULAR BUNDLES SPARED USING CLIPS AND SHARP DISSECTION. THE URETHRA WAS TAKEN WITH CAUTERY. THE RECONSTRUCTION WAS INITIALLY CREATED, BUT HAD TO BE REDONE AS IT HAD BEEN DISRUPTED. AFTER THE ANASTOMOSIS WAS REDONE, THE BLADDER WAS TESTED AND THE ANASTOMOSIS WAS NOTED TO BE WATER TIGHT. THEN BILATERAL PELVIC LYMPH NODE DISSECTION WAS PERFORMED WITH SCISSORS AND CAUTERY. THE WOUNDS WERE CLOSED AND THE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI FIBROID REMOVAL PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HEAVY BLEEDING AND DIARRHEA, INFECTION, HEMATOMA, PAIN AND TENDERNESS AT INCISION SITE.