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 — 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 — 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 — 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.

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 FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI NISSEN FUNDOPLICATION PROCEDURE ON (B)(6) 2013 AND ALLEGED TO HAVE INJURIES INCLUDING AVULSION OF THE LIVER. 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION AND MEDICAL RECORDS REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI OOPHORECTOMY PROCEDURE ON (B)(6) 2013. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT HAD A HYSTERECTOMY IN THE PAST AND WAS DIAGNOSED WITH AN OVARIAN CYST IN (B)(6) 2012. THE (B)(6) 2013 DA VINCI OOPHORECTOMY OPERATIVE REPORT INDICATED THAT THE PATIENT'S DIAGNOSES WERE PELVIC PAIN AND LEFT OVARIAN CYST. FINDINGS INCLUDED ADHESIVE DISEASE, PARTICULARLY IN THE AREA OF THE LEFT OVARY. THE LEFT OVARY WAS NOTED TO HAVE A 3 CM CYSTIC STRUCTURE. PROCEDURES PERFORMED INCLUDED LEFT SALPINGO-OOPHORECTOMY AND LYSIS OF ADHESIONS. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM IN STABLE CONDITION. THE OPERATIVE REPORTS DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. MEDICAL RECORDS INVOLVING THE PATIENT'S CARE FROM (B)(6) 2013 TO (B)(6) 2013 WERE PROVIDED. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT UNDERWENT MULTIPLE SUBSEQUENT SURGERIES, INCLUDING AN EXPLORATORY LAPAROTOMY PROCEDURE FOR A PERFORATED BOWEL ON (B)(6) 2013, OPEN CHOLECYSTECTOMY WITH DRAINAGE OF AN ABDOMINAL ABSCESS ON (B)(6) 2013, AND A W

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION INCLUDING MEDICAL RECORDS CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMIES ON (B)(6) 2013. THE PATIENT'S MEDICAL RECORDS INDICATE THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS. ACCORDING TO THE MEDICAL RECORDS PROVIDED, THE PATIENT HAD PREOPERATIVE DIAGNOSIS OF PELVIC PAIN, MENORRHAGIA, DYSMENORRHEA, AND DYSPAREUNIA. ACCORDING TO THE OPERATIVE REPORT, THE UTERUS WAS REMOVED WITHOUT DIFFICULTY AND THE VAGINAL CUFF WAS CLOSED WITH A 0 V-LOC SUTURE. EXCELLENT HEMOSTASIS WAS CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE WELL AND NO INTRA-OPERATIVE COMPLICATIONS WERE NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT WAS EVALUATED IN AN EMERGENCY ROOM (ER) FOR REPORTED COMPLAINTS OF RIGHT FLANK AND ABDOMINAL PAIN, AND CONSTIPATION. A CT SCAN OF THE PATIENT'S ABDOMEN AND PELVIS REVEALED MILD RIGHT HYDRONEPHROSIS AND A POSSIBLE DISTAL RIGHT URETERAL INJURY WITH CONTRAST EXTRAVASATION INTO A 4.5 X 6.5 CM PELVIC FLUID COLLECTION. THAT SAME DAY, A RIGHT PERCUTANEOUS NEPHROSTOMY TUBE WAS PLACED. ACCORD

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI TOTAL HYSTERECTOMY FOR MENORRHAGIA WITH ENLARGED FIBROID UTERUS GREATER THAN 250G ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. MULTIPLE LABORATORY AND RADIOLOGIC FINDINGS WERE PROVIDED AS WELL AS NARRATIVES FROM POST-OPERATIVE VISITS TO PCPS AND SUBSEQUENT HOSPITAL VISITS. 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 UTERUS WAS NOTED TO BE VERY LARGE, AND MOBILE. BOTH URETERS WERE VISUALIZED AND PERISTALSING NORMALLY. INDIGO CARMINE WAS ADMINISTERED AND FLOW FROM URETERS WAS VISUALIZED. BLOOD LOSS WAS APPROXIMATELY 100ML. THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM, HAVING TOLERATED THE PROCEDURE WELL. DATE OF DISCHARGE NOT SPECIFIED. THE PATIENT WAS ADMITTED ON (B)(6) 2013 AFTER PRESENTING TO THE ER WITH INCREASING PAIN AND DISCOMFORT. A CT SCAN SHOWED FLUID IN THE PELVIS LEADING TO POTENTIAL CONCERN FOR POSSIBLE PERFORATION. RECTAL CONTRAST CONFIRMED A LEAK. ON (B)(6) 2013, A LAPAROTOMY

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: INJURIES TO MY BLADDER, COLON, BURS, PELVIS, AND MY LUNGS COLLAPSE, LIVER AND SPLEEN..SURGERY WAS PERFORMED AT (B)(6) WITH THE ASSIST. OF THE DA VINCI ROBOT. I RECEIVED LAPAROSCOPIC LYSIS OF ADHESIONS, ROBOTIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY SURGERY. PERFORMED BY SURGEON (B)(6) ON (B)(6) 2013. TRANSFERRED MY CARE TO (B)(6) STARTED SEEING A DR. (B)(4) GI SPECIALIST WHO RECOMMEND I SEE A COLORECTAL SURGEON BY THE NAME OF (B)(6). SHE PERFORMED MULTIPLE SURGERIES BUT FAIL TO NOTE THE INFORMATION IN THE OPERATIVE REPORT. DR. (B)(6) SCHEDULE ME TO HAVE A COLONOSCOPY PERFORMED ON (B)(6) 2014. MY COLONOSCOPY WAS INCOMPLETE AND I NEVER WAS INFORMED WHY AND SURGERY WAS PERFORMED BUT NEVER MENTION IN THE OPERATIVE REPORT. I REPORTED THIS INFORMATION TO PATIENTS RELATION AND THE MATTER WAS INVESTIGATED. I RECEIVED A LETTER FROM PATIENT'S RELATION STATING DR. (B)(6) WILL NO LONGER BE PRACTICING WITH (B)(6). MY MEDICAL RECORDS WAS BOTCHED TO COVER UP MY INJURIES FROM (B)(6). HAVE HIRED BOTH OF THE SURGEONS. I HAVE PROOF OF EVERYTHING STATED. I ALSO DEVELOPED C-DIFF AND FEVER AFTER SURGERY FOR THREE CONSECUTIVE DAYS. NO FEEL IN THE LEFT SIDE OF MY ARM, HORRIBLE PAIN. COULD NOT WA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) RECEIVED INFORMATION FROM AN ATTORNEY REPRESENTING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013, AND ALLEGED TO HAVE INJURIES INCLUDING A TRANSECTED URETER AND SEPSIS. 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 DA VINCI SI ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR ENDOMETRIAL CANCER 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. BOTH MONOPOLAR AND BIPOLAR ENERGY WERE USED DURING THE OPERATION. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2013 PATIENT PRESENTED WITH INCREASING ABDOMINAL PAIN AND DIFFICULTY URINATING. A CT SCAN WAS WORRISOME FOR A LOWER URINARY TRACT INJURY. SHE WAS TAKEN TO THE OPERATING ROOM WHERE SHE WAS FOUND TO HAVE A COMPLETE TRANSECTION OF HER LEFT URETER 4 CM PROXIMAL TO THE BLADDER WITH DEVITALIZATION. SHE UNDERWENT A LEFT URETERONEOCYSTOSTOMY WITH A STENT. NO FURTHER INFORMATION IS 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) 2014, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/IMPORTER REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: THE PATIENT WAS UNDERGOING A ROBOTIC HYSTERECTOMY, RIGHT SALPINGECTOMY AND EXCISION OF ENDOMETRIOSIS. DURING THE PROCEDURE THE SURGEON THOUGHT THERE WAS A BURN ON THE ANTERIOR ABDOMINAL. BIPOLAR SHEARS HAD BEEN USED PRIOR TO THIS DISCOVERY, AND THE SURGEON FEARED POSSIBLE ARCING. THE DEFECT MAY HAVE BEEN A TRAUMA FROM MANIPULATION OR AN ACTUAL BURN. A SECOND SURGEON WAS CALLED IN TO ASSIST WITH EVALUATION OF THE ENTIRE BOWEL FOR ANY POSSIBLE DEFECT. THIS PROLONGED THE PROCEDURE SIGNIFICANTLY. NO ADDITIONAL DEFECTS WERE NOTED AND THE PATIENT RECOVERED WELL.

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 INJURIES TO HER BLADDER AND DAMAGES THEREFROM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED (B)(4) FROM THE HOSPITAL. THE EVENT DETAILS ARE PROVIDED BELOW: PLEASE NOTE THE 5 CASES BEING REPORTED CONCURRENTLY BY OUR FACILITY HAVE THE D VINCI ROBOT AS A COMMONALITY; WE ARE NOT IMPLYING THAT IT IS THE CAUSE. OUR FACILITY HAS TWO D VINCI ROBOTS. WE ARE UNCERTAIN WHICH OF THE TWO WAS USED IN THIS CASE. ON (B)(6) 2013 THE PATIENT UNDERWENT D¿VINCI PELVISCOPY WITH EXCISION OF ENDOMETRIOSIS. DURING PROCEDURE, IT WAS NOTICED THAT PATIENT HAD ADHESIONS, SO SURGEON WAS CALLED IN TO DO LYSIS OF ABDOMINAL PELVIC ADHESIONS. THE PATIENT WAS DISCHARGED TO HOME (B)(6) 2013. ON (B)(6) 2013, PATIENT WAS READMITTED WITH ABDOMINAL PAIN. CT OF ABDOMEN AND PELVIS FAIRLY UNREMARKABLE. THE PATIENT WAS OBSERVED IN THE HOSPITAL. WITH NO FEVERS, WELL-CONTROLLED PAIN, ABDOMEN WOUND CLEAN AND DRY. PATIENT WAS DISCHARGED ON (B)(6) 2013. THE PATIENT WAS READMITTED THE SAME DAY (B)(6) 2013. THE PATIENT UNDERWENT AN OPEN LAPAROSCOPIC EXPLORATION WITH REPAIR OF SIGMOID COLON PERFORATION. PATIENT WAS DISCHARGED 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: REFER TO H10/H11 FOR FOLLOW-UP 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)(6) 2013, ISI RECEIVED MEDWATCH REPORT NUMBER HCA (B)(4). THE EVENT DETAILS ARE PROVIDED BELOW: ROBOTIC-ASSISTED TOTAL HYSTERECTOMY, CYSTOSCOPY AND VENTRAL HERNIA REPAIR ON (B)(6) 2013. DURING THIS SURGERY AN (B)(6) UTERUS WITH MULTIPLE FIBROIDS WERE REMOVED. THE UTERUS WAS NOTED TO BE MARKEDLY ENLARGED AND IRREGULARLY SHAPED DUE TO THE MULTIPLE FIBROIDS. PATIENT DEVELOPED MULTIPLE BACK BLEEDERS AND THESE WERE CAUTERIZED WITH BIPOLAR CAUTERY. DUE TO THE "GINORMOUS" SIZE OF THE UTERUS, IT DID NEED TO BE MORCELLATED. INDIGO CARMAINE WAS GIVEN IV AND THE CYSTOSCOPY WAS PERFORMED; 70 DEGREE SCOPE WAS USED AND BOTH URETERAL JETS WERE EASILY VISUALIZED AND RELEASED INDIGO CARMINE. AT THE COMPLETION OF THIS PROCEDURE, THERE WAS NO FREE FLOW FROM VAGINA. FIVE DAYS POST OP ((B)(6) 2013) THE PATIENT DEVELOPED SEVERE PAIN AND CLEAR DISCHARGE FROM VAGINA. PATIENT RETURNED TO THE OPERATING ROOM AND IT WAS DISCOVERED THE PATIENT HAD SUSTAINED A THERMAL INJURY TO HER R URETER. A STENT WAS ATTEMPTED BUT UNABLE TO PASS THROUGH AREA OF INJURY. A PERCUTANEOUS NEPHROSTOMY TUBE DRAIN WAS THEN USED. ON (B)(6) 2013 SUCCESSFUL URETERAL RE-IMPLANTATION OCCURRED.

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 COLPOSUSPENSION 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 A LACERATION OF HER ILIAC VEIN AND THAT SHE SUFFERED FROM INJURIES AND DAMAGED THEREFROM.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PATIENT CAME IN ELECTIVELY FOR ROBOTIC COLPOSUSPENSION WITH MESH, TENSION-FREE VAGINAL TAPE (TVT), ANTERIOR POSTERIOR (AP) REPAIR. DURING THE PROCEDURE VASCULAR SURGERY HAD TO BE CALLED EMERGENTLY TO THE OPERATING ROOM TO ASSESS PATIENT WHO HAD MASSIVE BLEEDING DURING THE ROBOTIC PROCEDURE. THE ABDOMEN HAD BEEN OPENED BY THE PRIMARY SURGEON AND PRESSURE WAS BEING USED TO CONTROL THE BLEEDING. THE PATIENT HAD TO HAVE HER ABDOMEN OPENED WITH A MIDLINE INCISION FOR REPAIR OF LEFT ILIAC VEIN. AFTER EXPOSURE OF THE AREA MULTIPLE SMALL VENOTOMIES IN THE LEFT ILIAC VEIN WERE NOTED ADJACENT TO AN AREA CONTAINING GORTEX SUTURE AND MESH. THESE AREAS WERE REPAIRED.

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 INCLUDING MEDICAL RECORDS REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY WITH SALPINGECTOMY PROCEDURE ON (B)(6) 2013 WHO REPORTEDLY SUSTAINED A BOWEL INJURY AND DEVELOPED A FISTULA FOLLOWING THE SURGICAL PROCEDURE. ACCORDING TO THE (B)(6) 2013 DA VINCI HYSTERECTOMY OPERATIVE REPORT, THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS METRORRHAGIA. THE PATIENT'S UTERUS AND ADNEXA WERE NOTED TO BE NORMAL SIZE. THERE WERE EXTENSIVE SEVERE DENSE ADHESIONS OF THE SMALL INTESTINE THAT EXTENDED FROM THE XIPHOID PROCESS OVER THE UMBILICUS AND DOWN TO THE PUBIC BONE. NO EVIDENCE OF ENTEROTOMY OR CYSTOTOMY WAS NOTED. THE OPERATIVE REPORT INDICATED THAT THE BOWEL ADHESIONS THAT EXTENDED INTO THE FASCIA FROM THE PATIENT'S PRIOR SURGERY. CYSTOURETHROSCOPY SHOWED NO EVIDENCE OF A BLADDER INJURY. NO COMPLICATIONS WERE NOTED AND THE PATIENT'S POST-OP CONDITION WAS STABLE. THE PATIENT'S DISCHARGE SUMMARY WAS NOT PROVIDED; HOWEVER, THE (B)(6) 2013 OPERATIVE REPORT INDICATED THAT HER DISPOSITION WAS HOME. THE PATIENT'S MEDICAL RECORDS INDICATED THAT THE PATIENT SOUGHT MEDICAL ATTENTION POST OP DAY 1 AT THE EMERGENCY ROOM FOR ABDOMINA

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 ROBOTIC TOTAL LAPAROSCOPIC HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY FOR UTERINE FIBROIDS AND PELVIC PAIN 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. A 12 WEEK SIZE, MOBILE UTERUS WAS OBSERVED. A VCARE UTERINE MANIPULATOR WAS PLACED. A VERESS NEEDLE WAS PLACED AND 3L OF CARBON DIOXIDE INSUFFLATED. PORT PLACEMENT WAS PERFORMED USING A 5MM LAPAROSCOPE THROUGH A VISIPORT TROCAR. A 12MM PORT WAS PLACED IN THE UMBILICUS. TWO 8MM PORTS WERE PLACED TO THE LEFT AND RIGHT OF THE UMBILICUS, LATERAL TO THE RECTUS MUSCLES. MARCAINE WAS INFILTRATED INTO THE SKIN AND AT THE PORT SITES. PATIENT WAS PLACED IN DEEP TRENDELENBURG AND THE ROBOT WAS BROUGHT TO THE RIGHT SIDE OF THE TABLE AND DOCKED. A FENESTRATED BIPOLAR WAS PLACED IN THE LEFT PORT AND A MONOPOLAR SCISSORS IN THE RIGHT PORT. THE UTERUS, TUBES, AND OVARIES WERE ATTEMPTED TO BE REMOVED THROUGH THE VAGINA BUT WERE TOO LARGE. THE ROB

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 PULMONARY LOBECTOMY PROCEDURE, THE PATIENT EXPERIENCED UNCONTROLLED BLEEDING. THE SURGEON MADE THE DECISION TO CONVERT THE SURGICAL PROCEDURE TO 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: 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 A BLADDER PERFORATION. 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 WHO UNDERWENT A DA VINCI PROSTATECTOMY ON (B)(6) 2013. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT WAS GRAVELY INJURED AS A RESULT OF THE MALFUNCTIONING ROBOTIC DEVICE. ACCORDING TO THE LEGAL DOCUMENT, THE SURGEON FOUND A SMALL TEAR ON THE PATIENT'S RECTUM DURING DISSECTION AND AFTER THE PROSTATE HAD BEEN COMPLETELY FREED. THE LEGAL DOCUMENT ALSO INDICATES THAT, DURING THE ANASTOMOSIS, THERE WERE AT LEAST 10 EPISODES OF ALARMS THAT WENT OFF, SECONDARY TO THE RIGHT HAND OF THE PROSTATE. THIS, ON TWO SEPARATE OCCASIONS, BROKE THE SUTURE AND ON EVERY OTHER SITUATION, CASED THE 1 ARM TO DROP THE NEEDLE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI S TOTAL HYSTERECTOMY AND SACROCOLPOPEXY FOR PELVIC ORGAN PROLAPSE ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES HOSPITAL REPORTS AND OFFICE NOTES THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY]. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2013 THE PATIENT UNDERWENT ROBOTIC HYSTERECTOMY AND SACRAL COLPOPEXY. ON (B)(6) 2013 ER VISIT FOR PELVIC PAIN. DEVELOPMENT OF ABDOMINAL WALL ABSCESS WHICH WAS DRAINED AND A WOUND VAC WAS APPLIED. A RECTOVAGINAL FISTULA WAS SUSPECTED AND MANAGED CONSERVATIVELY. SHE WAS STARTED ON TPN NUTRITION (B)(6) 2013 AND WAS DISCHARGED ON (B)(6) 2013. PATIENT HAD WOUND CARE FOR SEVERAL MONTHS AND COMPLETED CASE IN (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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: REMAINS PAINFUL INTERNALLY, HAD INFECTION WHICH KEPT HER IN THE HOSPITAL FOR (5) DAYS.

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) 2013. THE LEGAL DOCUMENT ALLEGED THAT THE PATIENT SUSTAINED A SEVERED URETER INJURY. 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: (B)(6) RE: DA VINCI ROBOT IS A VERY DANGEROUS OPERATION DEVICE. DEAR SIR: I AM WRITING A LETTER TO YOU EXPLAINING JUST WHAT HAPPENED TO ME WHEN I WAS OPERATED ON VIA DA-VINCI ROBOT. FIRST OF ALL, MY UROLOGIST/SURGEON (MR. (B)(6)) TOLD ME AND MY FAMILY THAT I HAD DEVELOPED PROSTATE CANCER AND THAT I WOULD HAVE TO HAVE MY PROSTATE REMOVED. ON THE GLEASON SCALE READING OF 6, DR. (B)(6) SAID THAT HE RECOMMENDED USING THE DA-VINCI ROBOT BECAUSE IT WOULD DO A BETTER JOB AND THAT IT WOULD ALLOW HIM TO SEE EVERYTHING ON A BIG SCREEN SO THAT HE WOULD BE ABLE NOT TO CUT ANY NERVES OR BLOOD VESSELS THAT WOULD AFFECT ME FROM HAVING SEX AND THAT IT WOULD PREVENT ME FROM HAVING INCONTINENCE. DR. (B)(6) CONVINCED ME AND MY FAMILY THAT THE DA-VINCI ROBOT WAS THE WAY TO GO AND THAT MY FAMILY COULD PICK ME UP AT THE HOSPITAL THE NEXT MORNING. WHEN MY FAMILY CAME TO GET ME, I WAS IN A BAD WAY. I COULD NOT STAND, EAT, MOVE AND I WAS IN SO MUCH PAIN. THE NURSES HAD PUT ON ME A DRAINAGE BAG AND ABOUT EVERY TWO HOURS THE BAG WOULD FILL UP WITH BRIGHT RED BLOOD JUST LIKE IF I HAD JUST CUT MYSELF. DRAINAGE WOULD NOT BE THE SAME COLOR AS PURE BLOOD. DR. (B)(6) TOLD MY FAMILY THAT I WOULD NOT BE GOING HOME 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: ON (B)(4) 2012, ISI RECEIVED A LEGAL FILING CONCERNING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY SURGERY. THE LEGAL FILING ALLEGED THAT THE PATIENT SUSTAINED DAMAGE TO HER UTERUS, 'THE PATIENT CONTINUES TO SUFFER FROM ABDOMINAL PAIN, PELVIC PAIN, DYSPAREUNIA, BLOATING, ABDOMINAL DISTENTION, FATIGUE AND DECREASED ENERGY AND STAMINA. DUE TO THE INJURY SUSTAINED TO HER VAGINAL CUFF AND BOWEL DURING THE DAVINCI ROBOTIC HYSTERECTOMY, PATIENT HAD TO HAVE MULTIPLE ADDITIONAL MEDICAL TESTS AND PHYSICIAN CONSULTATIONS AND HAS SUFFERED PAIN, LOSS OF FUNCTION, EMOTIONAL DISTRESS, AND PERMANENT INJURY. PATIENT HAS SUFFERED THE LOSS OF CONSORTIUM.'

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 GALL BLADDER REMOVAL AND HERNIA REPAIR PROCEDURE ON (B)(6) 2013. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: HERNIA RUPTURED HAD TO HAVE A RESECTION 4 DAYS AFTER HERNIA REPAIR AND HAD RUPTURED HERNIA LEAKED INTO THE SMALL BOWEL. PATIENT HAD TO REMOVE 4' OF HER INTESTINE/ 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: AS PART OF A LEGAL MEDIATION EFFORT, INTUITIVE SURGICAL, INC. (ISI), RECEIVED INFORMATION AND THE MEDICAL RECORDS OF A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY WITH CYSTOSCOPY PROCEDURE ON (B)(6) 2013. THE PATIENT'S PREOPERATIVE DIAGNOSIS INCLUDED BILATERAL PELVIC ENDOMETRIOSIS. ON (B)(6) 2013, THE PATIENT UNDERWENT A FLUOROSCOPY PROCEDURE AND IT WAS DISCOVERED THAT THE PATIENT HAD A PERIRECTAL OR PRESIGMOID MASS DEFORMING THE COLON WITH AN ASSOCIATED RECTOVAGINAL FISTULA. ACCORDING TO THE OPERATIVE (OR) REPORT REGARDING THE SURGERY ON (B)(6) 2013, THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS STATED THAT A CYSTOSCOPY PERFORMED DURING THE PROCEDURE SHOWED NO INJURY TO THE PATIENT'S BLADDER AND BILATERAL URETERAL EFFLUX. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES OCCURRED AND THERE WAS NO INDICATION THAT THE PATIENT EXPERIENCED ANY INTRAOPERATIVE COMPLICATIONS. IT WAS STATED THAT THE PATIENT WAS AWAKENED AND TAKEN TO THE RECOVERY ROOM IN STABLE CONDITION. ACCORDING TO THE PATIENT'S PROGRESS NOTES DATED (B)(6) 2013, POST-OPERATIVELY THE PATIENT DEVELOPED HIGH FEVERS

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 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.

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 ST BENIGN HYSTERECTOMY PROCEDURE WAS PERFORMED, THE PATIENT CAME BACK TO THE HOSPITAL WITH POST-OPERATIVE SYMPTOMS OF PRESSURE AND BLOATING. THE SURGEON OPENED THE PATIENT AND REPORTEDLY NOTICED A SMALL BOWEL INJURY. THE SURGEON PROCEEDED TO PERFORM A BOWEL RESECTION PROCEDURE. DURING THE BOWEL RESECTION PROCEDURE, THE PATIENT WAS PLACED ON A VENTILATOR. THE PATIENT REPORTEDLY ALMOST PASSED AWAY DURING THE BOWEL RESECTION PROCEDURE FOR AN UNKNOWN REASON. AT THE TIME THE INITIAL REPORTER REPORTED THE EVENT TO INTUITIVE SURGICAL INC. (ISI), THE PATIENT WAS IN THE ICU AND WAS DOING WELL.

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.

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 INJURIES AND DAMAGES.

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

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 DA VINCI S HYSTERECTOMY PROCEDURE ON (B)(6) 2013, AND ON (B)(6) 2013, THE PATIENT ALLEGEDLY EXPERIENCED SEPTIC SHOCK. THE SURGEON INDICATED THAT THE HYSTERECTOMY PROCEDURE WENT WELL AND HE DID NOT OBSERVE ANY ERRORS DURING THE CASE. ACCORDING TO THE SURGEON, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) IN SEPTIC SHOCK ON (B)(6) 2013, AND A SECOND DOCTOR PERFORMED A DIAGNOSTIC LAPAROTOMY. DURING THE DIAGNOSTIC LAPAROTOMY, THE SURGEON WHO PERFORMED THE HYSTERECTOMY PROCEDURE WAS PRESENT. HE CLAIMED THAT NO FACTORS WERE IDENTIFIED FOR THE CAUSE OF THE SEPSIS DURING THE DIAGNOSTIC LAPAROTOMY. THE SECOND DOCTOR THEN PERFORMED AN EXPLORATORY LAPAROTOMY PER THE REQUEST OF THE SURGEON SINCE THE PATIENT WAS IN SEPSIS. DURING THE EXPLORATORY LAPAROTOMY, THE PATIENT'S APPENDIX WAS FOUND TO BE INFLAMED AND A SMALL MARK WAS OBSERVED ON THE PATIENT'S BOWEL. THE SURGEON DENIED THAT FECES WAS OBSERVED IN THE PATIENT'S ABDOMINAL CAVITY. THE SECOND DOCTOR REPORTEDLY APPLIED SEVERAL SUTURES OVER THE SMALL MARK ON THE PATIENT'S BOWEL AND A TEMPORARY DIVERTING ILEOSTOMY WAS CREATED.

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 SUPRACERVICAL HYSTERECTOMY PROCEDURE ON (B)(6) 2013 FOR MASSIVE FIBROID UTERUS. ISI WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP RADIOLOGY REPORTS. THERE WAS NO ALLEGATION 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) 2013, THE PATIENT REPORTED LEAKING URINE PER VAGINA. ON (B)(6) 2013, SHE PRESENTED TO A DIFFERENT HOSPITAL WITH FREE FLUID IN HER ABDOMEN AND PELVIS. SHE HAD ACUTE RENAL FAILURE, WHICH RESOLVED. SHE REQUIRED PARACENTESIS TO REMOVE THE FREE ABDOMINAL/PELVIC FLUID AND A CYSTOSCOPY WITH RETROGRADE PYELOGRAMS REVEALED A HEALING 1 CM BLADDER LACERATION AT THE RIGHT DOME. ADDITIONAL CYSTOSCOPY REVEALED ONGOING LEAKAGE WITH BLADDER DISTENTION. A FOLEY CATHETER WAS LEFT IN PLACE FOR APPROXIMATELY 2 WEEKS. SHE MISSED A TOTAL OF APPROXIMATELY 6 WEEKS OF WORK (4 MORE WEEKS THAN ANTICIPATED).

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 HYSTERECTOMY AND LYSIS OF ADHESIONS FOR A HISTORY OF DYSFUNCTIONAL UTERINE BLEEDING, PELVIC PAIN, UTERINE FIBROID, AND PRESENCE OF EXTENSIVE ABDOMINAL/PELVIC ADHESIONS ON (B)(6) 2013. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT FOR THE PRIMARY SURGERY AND THE URETERAL REIMPLANTATION. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGERY WAS NOTABLE FOR THE EXTENSIVE ABDOMINAL ADHESIONS FROM THE ANTERIOR PORTION OF THE UTERUS TO THE ANTERIOR WALL OF THE ABDOMEN WHICH HAD TO BE TAKEN DOWN WITH AN ENSEAL LIGATOR BEFORE THE HYSTERECTOMY COULD START. THE UTERINE CORNEAL ATTACHMENTS, AND UTERINE VESSELS WERE CAUTERIZED AND CUT, THE BLADDER WAS BLUNTLY AND SHARPLY DISSECTED INFERIORLY AND THE CULPOTOMY COMPLETED. THE UTERUS WAS DELIVERED THROUGH THE VAGINA, AND THE VAGINAL CUFF CLOSED WITH V-LOCK SUTURES. THE CYSTOSCOPY WAS PERFORMED WITH IV INDIGO CARMINE, AND BOTH URETERAL ORIFICES WERE SEEN EJECTING DYE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. ON (B)(6) 2013 PATIENT PRESENTED WI

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 PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT SIDE MANIPULATOR ARM 1 BEHAVED IN A SLUGGISH MANNER. THE SITE CONTACTED ISI TECHNICAL SUPPORT ENGINEERING AND INDICATED THAT THEY TROUBLESHOT THE ISSUE BY INSTALLING DIFFERENT INSTRUMENTS ONTO TO THE AFFECTED PSM; HOWEVER, THE ISSUE PERSISTED. THE OR NURSE INDICATED TO THE TSE THAT THEY WERE NOT VERY DEEP INTO THE PATIENT AND THAT THEY COULD NOT OBSERVE ANY INTERFERENCE WITH THE INSTRUMENT OR PSM. THE SITE DECLINED FURTHER TROUBLE-SHOOTING ASSISTANCE AND INDICATED THAT THEY WERE GOING TO PROCEED WITH THE PROCEDURE. ON (B)(4) 2013, THE ISI CLINICAL SALES REPRESENTATIVE FOLLOWED UP WITH THE SURGEON CONCERNING THE REPORTED EVENT. THE CSR INDICATED THAT THE SURGEON INDICATED TO HIM THAT THE PATIENT'S VENA CAVA WAS DAMAGED EARLIER IN THE PROCEDURE AND DURING REPAIR OF THE PATIENT'S ANATOMY, HE EXPERIENCED ARTICULATION ISSUES WITH THE INSTRUMENTS INSTALLED ON THE 1 PSM AND THE 2 PSM. THE CSR INDICATED THAT THE SURGICAL STAFF TROUBLESHOT THE ISSUE BY RESEATING THE INSTRUMENTS AND THE STERILE ADAPTERS. HOWEVER, THE INSTALLED INSTRUMENTS INTERMITTENTLY FAILED TO ARTICULATE PROPERLY. THE CSR INDICATED THAT 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: DURING A USER INTERVIEW, IT WAS REPORTED TO ISI THAT A NURSE WAS INJURED AS SHE TRIED TO PULL THE PATIENT CART OF THE DA VINCI SURGICAL SYSTEM BACKWARDS (DATE OF EVENT WAS UNKNOWN; HOWEVER, IT WAS STATED THAT THIS HAS OCCURRED A WHILE AGO). REPORTEDLY, THE NURSE MAY HAVE GRABBED THE HANDLES TOO HARD AND THE PATIENT CART WENT BACK TOO FAR. ALLEGEDLY, THE NURSE'S HAND GOT STUCK BETWEEN THE WALL AND THE DA VINCI SYSTEM, AND SHE WAS UNABLE TO LET GO. ACCORDING TO THE REPORTER OF THIS COMPLAINT, THE NURSE WAS OUT FOR 6-8 WEEKS, BUT NOTHING WAS BROKEN.