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. EXACT PROCEDURE DATE IS UNKNOWN AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY:SURGEON CUT HOLE IN BLADDER. PATIENT HAS BEEN IN EXTREME PAIN, LEAKING URINE INTO ABDOMEN, AND BURN IN BLADDER.

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 SOMETIME IN 2010. EXACT DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SPORADIC, SEVERE ABDOMINAL PAIN, SCAR TISSUE AND PIECED OF LIGAMENTS ATTACHED TO BLADDER.

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 LOWER BYPASS PROCEDURE SOMETIME IN 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: THE PATIENT CLAIMS THE SURGERY WAS DONE WRONG AND HAD TO GET LEG REMOVED BECAUSE OF AN INFECTION, DETERIORATION OF BONES AND HERNIA. NO FURTHER CLINICAL INFORMATION HAS BEEN 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 PROSTATECTOMY PROCEDURE ON (B)(6) 2007. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DAMAGE CAUSED TO BLOOD VESSELS AND NERVES NEAR 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 RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON 2010. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SEVERE HEMORRHAGING REQUIRING BLOOD TRANSFUSIONS.

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 LEFT KIDNEY REMOVAL IN 2012. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DEVICE HAD NICKED HIS BOWEL AND PATIENT WAS REQUIRED TO HAVE CORRECTIVE SURGERY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PARTIAL HYSTERECTOMY SOMETIME IN 2012. EXACT DATE OF PROCEDURE WAS NOT PROVIDED AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT'S ABSCESS GREW ON HER INTESTINE AND IT WAS IMPACTING HER BOWELS. THE ABSCESS WAS REMOVED SOMETIME 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 HYSTERECTOMY PROCEDURE ON SOMETIME IN (B)(6) 2012. EXACT PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INTESTINES WERE PUNCTURED AND SURGICAL CORRECTION WAS NEEDED.

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 IN 2011. EXACT DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PATIENT DOES NOT HAVE ANY CONTROL OF BLADDER AND REQUIRED 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTEROTOMY SOMETIME IN 2009. EXACT DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DIVERTICULITIS, PAIN, CRAMPING AND PERFORATED 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE SOMETIME IN 2008. EXACT PROCEDURE DATE IS IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: DESTROYED ALL NERVES, HAD NO FEELINGS, NO SEXUAL RESPONSE, AND INCONTINENCE.

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 PROSTATE CANCER PROCEDURE IN (B)(6) 2007. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: 'TWISTED BOWEL, 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 DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL HYSTERECTOMY PROCEDURE IN 2009/2010. EXACT DATE OF PROCEDURE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: PUNCTURED BLADDER DURING SURGERY, CATHETERIZED FOR 6 WKS., NEVER REGAINED FULL SENSATION OF HAVING TO VOID.

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 BLADDER CANCER PROCEDURE ON 2009. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: INTESTINES HERNIATED.

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 PROSTATE REMOVAL DUE TO CANCER PROCEDURE ON (B)(6) 2010. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: NERVES IN PENIS WERE SHOCKED CAUSING HIM NOT TO HAVE AN ERECTION.

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 PROSTATE CANCER PROCEDURE ON (B)(6) 2012. PROCEDURE DATE IS UNKNOWN. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: SUTURE FAILURE ON THE BACK-SIDE OF AN ANATOMY.

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 RADICAL PROSTATECTOMY PROCEDURE IN (B)(6) 2007/2008. EXACT DATE OF PROCEDURE HAS NOT BEEN PROVIDED AT THIS TIME. THE LEGAL DOCUMENT RECEIVED ALLEGES THAT THE PATIENT SUFFERED THE FOLLOWING INJURIES DUE TO THE DA VINCI SURGERY: NEUROPATHY, PAIN SITTING AND STANDING.

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 PROSTATECTOMY WITH BILATERAL PELVIC LYMPH NODE DISSECTION, AND REPAIR OF UMBILICAL HERNIA ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT, AND NOTES FROM SUBSEQUENT PROCEDURES. DURING SURGERY THE RIGHT URETER WAS INADVERTENTLY CUT BY THE SURGEON, NOTED IMMEDIATELY, AND SPATULATED AND REPAIRED WITH 5-0 VICRYL SUTURE AND STENTED. IT WAS NOTED THAT THE PATIENT HAD A VERY THICKENED COVERING ON THE ANTERIOR SURFACE OF THE ABDOMEN MAKING DISSECTION DIFFICULT. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES DURING SURGERY. THE SURGEON COMPLETED A RADICAL PROSTATECTOMY WITH PLACEMENT OF TRANSPERINEAL STITCHES TO PROVED BLADDER TENSION, LYMPHADENECTOMY AND UMBILICAL HERNIA REPAIR WITHOUT ADDITIONAL COMPLICATION BEYOND THE INITIAL INADVERTENT SEVERING OF THE URETER. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2008 WITH THE RIGHT URETERAL STENT AND FOLEY CATHETER IN PLACE. ON (B)(6) 2008, THE PATIENT WAS SEEN FOR POORLY DISCHARGING FOLEY AND WAS FOUND TO HAVE A UTI. HIS FOLEY WAS REPLACED 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: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY FOR POORLY DIFFERENTIATED ENDOMETRIAL CANCER ON (B)(6) 2013. THE PATIENT ALSO UNDERWENT LYMPH NODE MAPPING, BILATERAL PELVIC AND PARA-AORTIC LYMPHADENECTOMY, OMENTAL BIOPSY, AND CYSTOSCOPY. 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. ACCORDING TO THE OPERATIVE REPORT, NO COMPLICATIONS WERE REPORTED. POST-OPERATIVELY, THE PATIENT'S MENTAL STATUS CONSISTED OF CONFUSION. HOWEVER, AT THE TIME OF DISCHARGE ON (B)(6) 2013, THE PATIENT WAS REPORTEDLY FINE. THE PATIENT HAD POSITIVE BOWEL SOUNDS. ON (B)(6) 2013, THE PATIENT HAD COMPLAINTS OF SEVERE LOWER ABDOMINAL PAIN AND COULD NOT GET OUT OF BED. PAIN MEDICATIONS WERE NOT HELPING. THE PATIENT WAS ADVISED TO CALL FOR AN AMBULANCE AND REPORT TO A PHYSICIAN AS SOON AS POSSIBLE. ON (B)(6) 2013, THE PATIENT WAS SEEN IN AN ER. THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS SINCE PRIOR TO SURGERY. SHE HAD N

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 S HYSTERECTOMY PROCEDURE, THE PATIENT CODED DURING VAGINAL CUFF CLOSURE. AT THE TIME THE PATIENT CODED, THE INITIAL REPORTER INDICATED THAT THE DA VINCI S SURGICAL SYSTEM WAS UNDOCKED FROM THE PATIENT. ACCORDING TO THE INITIAL REPORTER, THE SURGICAL STAFF WAS UNABLE TO REVIVE THE PATIENT WHO SUBSEQUENTLY PASSED AWAY.

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 FDA VOLUNTARY REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: UNDERWENT ROBOTIC -DA VINCI- PROCTECTOMY. RECTUM WAS PERFORATED AND NOT DETECTED UNTIL SEPSIS INFECTION HAD DEVELOPED REQUIRING EXTENDED HOSPITAL STAY AND NUMEROUS SURGERIES TO CLEAN OUT THE INFECTION AND PERFORM A COLOSTOMY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI SI SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A URETERAL INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI SI PROSTATECTOMY PROCEDURE ON AN UNSPECIFIED DATE. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF THE DA VINCI SI 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. DATE OF PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF A MALFUNCTION OR DEFECT 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. THE DATE OF THE PROCEDURE IS UNKNOWN. 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 COLON 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: AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI PROSTATECTOMY PROCEDURE. DATE OF THE PROCEDURE WAS NOT PROVIDED. THE LEGAL DOCUMENT ALLEGES THAT AS A DIRECT AND PROXIMATE RESULT OF A MALFUNCTION OR DEFECT 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 A PATIENT HAD UNDERGONE A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013 THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL DUE TO A BOWEL PERFORATION. IT IS UNKNOWN AT THIS TIME WHEN THE BOWEL PERFORATION WAS NOTICED. THE PATIENT WAS RECOVERING AT THE HOSPITAL AND IT IS UNKNOWN WHETHER THE PATIENT HAD ANY OTHER COMPLAINTS. THE SURGEON MENTIONED TO THE CLINICAL SALES REPRESENTATIVE (CSR) THAT THE PROBLEM WAS DUE TO THE ASSISTANT. THE CSR DOES NOT HAVE ANY FURTHER CLINICAL INFORMATION AS HE WAS NOT AT THE SITE DURING THE DA VINCI HYSTERECTOMY PROCEDURE. INTUITIVE SURGICAL INC. (ISI) ATTEMPTED TO CONTACT THE SURGEON TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS INCIDENT; HOWEVER, HAS BEEN UNSUCCESSFUL IN GETTING A HOLD OF THE SURGEON. BASED ON THE INFORMATION PROVIDED, THE COMPLAINT IS BEING REPORTED, SINCE THE PATIENT HAD SUFFERED A BOWEL PERFORATION AFTER UNDERGOING A DA VINCI HYSTERECTOMY 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 SI OVARIAN CYSTECTOMY PROCEDURE, THE PATIENT SUSTAINED A SEROSAL TEAR TO THE BOWEL THAT WAS NOTICED AFTER INSUFFLATION WAS LOST. THE INJURY WAS REPAIRED DURING THE SURGICAL PROCEDURE. ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). THE CSR WAS PRESENT DURING THE SURGICAL PROCEDURE. ACCORDING TO THE CSR, THE EVENT OCCURRED TOWARDS THE END OF THE DA VINCI SI SURGICAL PROCEDURE. AT THE TIME THE EVENT OCCURRED, PNEUMOPERITONEUM WAS LOST FROM TUBING PLACED THROUGH A LAPAROSCOPIC ASSIST PORT. DUE TO LOSS OF INSUFFLATION, THE SURGICAL STAFF LOST VISION OF THE OPERATIVE FIELD. AFTER INSUFFLATION WAS LOST, A SEROSAL TEAR WAS NOTICED ON THE PATIENT'S BOWEL. ALTHOUGH THE BOWEL WAS NOT PERFORATED, A GYN SURGEON MADE THE DECISION TO APPLY SUTURES TO THE BOWEL INJURY AS A PRECAUTION. THE CSR STATED THAT THE DA VINCI SURGICAL PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF POST-OPERATIVE COMPLICATIONS. THE CSR STATED THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED 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 DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI TOTAL BENIGN HYSTERECTOMY PROCEDURE ON AN UNKNOWN DATE. 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. STATES PATIENT WAS MADE AWARE THAT HIS INJURIES MAY BE THE RESULT OF THE DA VINCI 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: IT WAS REPORTED THAT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE, THE PATIENT SUSTAINED A POSSIBLE INJURY OF THE INFERIOR EPIGASTRIC ARTERY UPON ENTRY OF A TROCAR. THE CLINICAL COORDINATOR INDICATED THAT THE PATIENT HAD EXCESSIVE BLEEDING AND WAS REFERRED TO A TRAUMA SURGEON ON POST-OP DAY 2. ACCORDING TO THE CLINICAL COORDINATOR, THE ARTERIAL INJURY WAS DISCOVERED DURING EXPLORATORY SURGERY. ON (B)(6) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE CLINICAL COORDINATOR. SHE WAS NOT PRESENT DURING THE REPORTED EVENT. SHE DID NOT KNOW WHO THE MANUFACTURER WAS OF THE TROCAR INVOLVED WITH THE EVENT. SHE ALSO DID NOT KNOW IF THE TROCAR ENTRY WAS RELATED TO A ROBOTIC PORT OR A LAPAROSCOPIC ASSIST PORT. THE CLINICAL COORDINATOR STATED THAT THE PATIENT WAS CURRENTLY STABLE AND HAS SINCE BEEN DISCHARGED HOME AFTER THE EVENT OCCURRED. NO ADDITIONAL 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 DURING A DA VINCI SI ATRIAL APPENDAGE LIGATION PROCEDURE, THE SURGEON INADVERTENTLY CUT THE ATRIAL ARTERY DUE TO IMPROPER ANATOMY IDENTIFICATION AND THE PATIENT SUBSEQUENTLY PASSED AWAY. THE OR DIRECTOR FROM THE SITE INDICATED THAT ADHESIONS AND HEART ANATOMY ALTERED DUE TO PREVIOUS SURGERY LEAD TO IMPROPER IDENTIFICATION OF ANATOMY. THE OR DIRECTOR STATED THE DA VINCI SYSTEM DID NOT CONTRIBUTE TO THE PATIENT OUTCOME. THE CLINICAL SALES REPRESENTATIVE (CSR) INDICATED THAT THE PATIENT HAD PREVIOUS HEART SURGERY AND THE LEFT ATRIAL ARTERY WAS REROUTED IN AN IMPROPER POSITION THAT THE SURGEON WAS NOT AWARE OF. THE CSR ALSO INDICATED THAT THE PATIENT HAD ADHESIONS THAT CONTRIBUTED TO IMPROPER ANATOMY IDENTIFICATION. AFTER THE ATRIAL ARTERY WAS INADVERTENTLY CUT, THE SURGEON MADE THE DECISION TO OPEN THE PATIENT UP AND ATTEMPT TO STOP THE BLEEDING. THE CSR INDICATED THAT THE PATIENT DID NOT SURVIVE THE SURGERY. ACCORDING TO THE CSR, THE SURGEON INDICATED THAT THE DA VINCI SYSTEM DID NOT MALFUNCTION DURING THE SURGICAL PROCEDURE AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE.

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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BOWEL INJURY. THE PATIENT UNDERWENT REPAIR OF THE BOWEL INJURY BY GENERAL SURGERY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2013. ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE RISK MANAGER (RM) FROM THE SITE. THE RM REVIEWED THE OPERATIVE REPORT AND DID NOT FIND ANY DOCUMENTATION THAT A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THERE ALSO WAS NO REPORT THAT ANY INTRA-OPERATIVE COMPLICATIONS OCCURRED DURING THE PROCEDURE. BASED ON THE RM'S REVIEW OF THE PATIENT'S MEDICAL RECORDS, THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 WITH REPORTED COMPLAINTS OF ABDOMINAL PAIN. ON (B)(6) 2013, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO EVALUATE A SUSPECTED PELVIC ABSCESS. THE FOLLOWING DAY ON (B)(6) 2013, THE PATIENT UNDERWENT REPAIR OF A PERFORATED BOWEL. ALSO, ON (B)(6) 2013, THE PATIENT UNDERWENT A SMALL BOWEL RESECTION PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITH A COLOSTOMY ON (B)(6) 2013. DURING THE COURSE OF THE HOSPITALIZATION, THE PATIENT WAS REPORTEDLY TREATED FOR SEPS

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, THE INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REP (CSR) REPORTED A NEEDLE DROPPING INTO A PATIENT DURING A DA VINCI SI PROSTATECTOMY PROCEDURE ON (B)(6) 2013. THE CSR REPORTED A LARGE NEEDLE DRIVER INSTRUMENT THAT WAS INSTALLED ON THE PATIENT SIDE MANIPULATOR 2 (PSM2) INADVERTENTLY OPENED AND THE NEEDLE HAD DROPPED INTO THE PATIENT. THE SITE RESEATED THE INSTRUMENT AND WAS ABLE TO OPERATE NORMAL. A C-ARM WAS USED; HOWEVER, THE SITE WAS UNABLE TO LOCATE THE NEEDLE. INFORMATION DETAILING THE EVENTS LEADING TO THE ALLEGED INADVERTENT DROP WAS NOT REPORTED AT THE TIME. ON (B)(6) 2013, ISI SPOKE WITH THE ISI CSR, WHO WAS THE INITIAL REPORTER. HE CONFIRMED WITH THE SURGEON THAT THE DROPPED NEEDLE HAS NOT BEEN RETRIEVED; HOWEVER, HE IS NOT AWARE OF THE PATIENT SUSTAINING ANY POST-OPERATIVE COMPLICATIONS. HE WAS UNABLE TO INDICATE HOW LONG THE INSTRUMENT WAS IN USE BEFORE THE NEEDLE DROPPED OUT OF THE INSTRUMENT. HE ALSO INDICATED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE SAME INSTRUMENT WITH NO ISSUES AFTER IT WAS RESEATED IN THE PSM2. THE SCRUB TECH ALSO INSPECTED THE INSTRUMENT AFTER THE PROCEDURE AND IT APPEARED FINE. HE WAS UNABLE TO PROVIDE THE LOT NUMBER 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: ON (B)(6) 2013, AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED A PATIENT INJURY THAT INCURRED DURING A DA VINCI SI HYSTERECTOMY PROCEDURE. ABOUT 4 HOURS INTO THE DA VINCI SI HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED BLOOD COMING OUT OF THE PATIENT'S EXTERNAL ILIAC VEIN. IT WAS ESTIMATED TO BE ABOUT A 5MM INJURY. PRESSURE WAS PUT ON THE INJURED VEIN AND THE SURGICAL STAFF CALLED THE VASCULAR SURGEON. WHEN THE VASCULAR SURGEON GOT TO THE OPERATING ROOM, THE INJURED VEIN HAD CLOTTED AND STOPPED BLEEDING. INFORMATION DETAILING THE EVENTS LEADING TO THE PATIENT'S VEIN INJURY WERE NOT PROVIDED. NO OTHER COMPLICATIONS WERE REPORTED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED TO CONTACT THE SITE FOR ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT.

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 UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: WHILE PERFORMING THE LAPAROSCOPIC ROBOTIC ASSISTED SACROCOLPOPEXY, THE SURGICAL TEAM NOTICED TWO HOLES IN THE BLADDER. IMMEDIATE REPAIR WAS PERFORMED PER PHYSICIAN.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2013, THE PATIENT EXPERIENCED POST-OPERATIVE COMPLICATIONS. AFTER BEING RELEASED FROM THE HOSPITAL ON AN UNSPECIFIED DATE, THE PATIENT INDICATED THAT SHE EXPERIENCED PAIN, DISCOMFORT, A BLADDER INFECTION, AND FLUID DISCHARGE. ON (B)(6) 2013, THE PATIENT CLAIMED THAT HER INCISION BURST AND HER BOWEL CAME OUT. THE PATIENT WAS REPORTEDLY RUSHED TO AN EMERGENCY ROOM (ER) AND REPAIR OF THE POST-OPERATIVE COMPLICATIONS WAS PERFORMED. THE DA VINCI SURGICAL SYSTEM WAS NOT USED DURING REPAIR OF THE POST-OPERATIVE COMPLICATIONS. THE PATIENT DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION ABOUT A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2013. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL BECAUSE FECAL MATTER WAS FOUND IN HER VAGINAL CANAL. THE PATIENT UNDERWENT A SMALL BOWEL REPAIR AND CURRENTLY HAS A COLOSTOMY. THE SITE REPORTED THERE WAS POSSIBLE UNINTENDED ARCING. NO OTHER DETAILS WERE PROVIDED AT THIS TIME. ON (B)(6) 2013, ISI SPOKE WITH ONE OF THE SITE'S CONTACTS AND OBTAINED ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2013, WHICH WAS 2 DAYS AFTER THE DA VINCI HYSTERECTOMY PROCEDURE. HE WAS UNABLE TO PROVIDE ANY DETAILS REGARDING THE PATIENT'S CONDITION BEFORE THE RE-ADMISSION. HE STATED THAT THE GENERAL SURGEON WHO PERFORMED THE SMALL BOWEL REPAIR BELIEVES THAT THE INJURY WAS ATTRIBUTED TO PULL AND TUG ISSUES AND NOT DUE TO A THERMAL INJURY. HE WAS UNABLE TO CONFIRM OR DENY IF THERE WERE ANY MALFUNCTIONS OF THE DA VINCI SYSTEM, INSTRUMENTS, AND OR ACCESSORIES THAT COULD HAVE CONTRIBUTED TO THE PATIENT'S INJURIES AND ADVISED ISI TO CONTACT THE ROBOTICS COORDINATOR, WHO WAS CURRENTLY OUT OF THE OFFICE, FOR MORE INFORMATION. ISI

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 UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: DURING A ROBOTIC ASSISTED HYSTERECTOMY, A HOLE WAS NOTED IN THE BLADDER. THE BLADDER WAS REPAIRED AND A CYSTOSCOPY PERFORMED BY THE PHYSICIAN.

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 LOBECTOMY PROCEDURE, THE SURGEON TORE THE PATIENT'S PULMONARY VEIN. THE INITIAL REPORTER INDICATED THAT WHILE THE SURGEON WAS USING A CADIERE FORCEPS INSTRUMENT AND A MARYLAND BIPOLAR FORCEPS INSTRUMENT, THE PATIENT'S PULMONARY VEIN WAS TORN. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT RECEIVED 20 UNITS OF BLOOD AND LEFT SURGERY IN STABLE CONDITION.

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 SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT PASSED AWAY. ACCORDING TO THE INITIAL REPORTER, THE SURGEON INFORMED HIM THAT THE PATIENT PASSED AWAY AFTER A SUCCESSFUL GASTRIC SLEEVE PROCEDURE. IN ADDITION, THE SURGEON STATED THAT THE PATIENT'S AUTOPSY DID NOT FIND ANY SURGICAL ISSUES.

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 PATIENT HAD A ROBOTIC COLPOSUSPENSION WITH MESH AND A BILATERAL SALPINGO-OOPHORECTOMY (S&O). SEVERAL DAYS POST OP SHE DEVELOPED POST OPERATIVE PAIN, NAUSEA AND VOMITING. GENERAL SURGERY WAS CONSULTED. AFTER SOME TESTS WERE DONE THE PATIENT WAS TAKEN BACK TO THE OR FOR AN EXPLORATORY LAPAROTOMY. A SMALL BOWEL IATROGENIC INJURY WAS FOUND AND REPAIRED. THE PATIENT TOLERATED THE PROCEDURE 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: ON (B)(4) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED UF/REPORT (B)(4) WITH THE FOLLOWING EVENT DESCRIPTION: EVENT DESC: THE PATIENT HAD A ROBOTIC COLPOSUSPENSION WITH MESH AND A BILATERAL SALPINGO-OOPHORECTOMY (S&O). SEVERAL DAYS POST OP SHE DEVELOPED POST OPERATIVE PAIN, NAUSEA AND VOMITING. GENERAL SURGERY WAS CONSULTED. AFTER SOME TESTS WERE DONE THE PATIENT WAS TAKEN BACK TO THE OR FOR AN EXPLORATORY LAPAROTOMY. A SMALL BOWEL IATROGENIC INJURY WAS FOUND AND REPAIRED. THE PATIENT TOLERATED THE PROCEDURE WELL.

da Vinci Surgical System — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL LOOP DIVERSION AND RADICAL PROSTATECTOMY WITH BILATERAL EXTENDED PELVIC LYMPH NODE DISSECTION PROCEDURE ON (B)(6) 2013. AT THE TIME, THE PATIENT WAS SUFFERING FROM PAPILLARY UROTHELIAL CARCINOMA, HIGH GRADE, OF THE BLADDER. THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PATIENT SUFFERED INJURIES THAT CAUSED HIM TO UNDERGO ADDITIONAL SURGERIES. ISI WAS NOT PROVIDED WITH THE OPERATIVE REPORT OR ANY OF THE PATIENT'S MEDICAL RECORDS. ACCORDING TO THE PLAINTIFF'S ATTORNEY, AROUND POST-OPERATIVE DAY 4, THE PATIENT BEGAN EXPERIENCING COMPLICATIONS HIGHLY INDICATIVE OF POSSIBLE BOWEL PERFORATION AND LEAK, WHICH SIGNS AND SYMPTOMS WERE NOT PROPERLY RECOGNIZED AND ADDRESSED UNTIL POST-OPERATIVE DAY FOURTEEN (14). AS A RESULT, THE PATIENT ALLEGEDLY DEVELOPED AN INTRA-ABDOMINAL ABSCESS AND SEPTIC SHOCK, AND ULTIMATELY PASSED AWAY ON (B)(6) 2013.

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 SUPRAGLOTTIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 2 DAYS LATER ON (B)(6) 2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO COMPLICATIONS DURING THE DA VINCI SI SURGICAL PROCEDURE AND THE PATIENT HAD BEEN TAKEN TO THE ICU FOR RECOVERY.

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: 'POSSIBLE BURN OR CUT IN INTESTINES OR LINING OF HER STOMACH, INCISION WAS INFECTED AND SHE CONTRACTED E COLI AFTER THE SURGERY. COULDN'T URINATE FOR ABOUT THREE MONTHS.'

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 HYSTERECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A BOWEL PERFORATION AND REPORTED COMPLAINTS OF SEVERE PAIN ON POST-OP DAY 1. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT WAS FOUND TO BE SEPTIC. ON POST-OP DAY 3, AN OPERATION WAS PERFORMED TO REMOVE NECROTIC BOWEL. THE PATIENT SUBSEQUENTLY 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI SIGMOID COLECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 7 DAYS LATER ON (B)(6)2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THE SURGEON PERFORMED AN ANASTOMOSIS DURING THE SURGICAL PROCEDURE AND A LEAK WAS FOUND AFTER A LEAK TEST WAS DONE. AFTER THE SURGEON REPAIRED THE LEAK BY APPLYING SUTURES, ANOTHER LEAK TEST WAS PERFORMED AND NO FURTHER COMPLICATIONS WERE FOUND. THE SURGICAL PROCEDURE WAS COMPLETED. THE DAY AFTER SURGERY, THE PATIENT WAS REPORTEDLY DOING FINE. HOWEVER, OVER THE FOLLOWING WEEKEND, THE PATIENT WAS NOT DOING WELL. ACCORDING TO THE INITIAL REPORTER, A CT SCAN WAS PERFORMED ON THE PATIENT ON (B)(6) 2013, AND NO ISSUES WERE SEEN. THE INITIAL REPORTER INDICATED, HOWEVER, THAT AN ANASTOMOSIS DYE TEST WITH X-RAY WAS PERFORMED AND A LEAK WAS SEEN. THE PATIENT WAS RUSHED TO SURGERY AND THE PATIENT EXPIRED IN THE OPERATING ROOM (OR).

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 PROSTATECTOMY PROCEDURE ON (B)(6) 2010, AND ALLEGED TO HAVE INJURIES INCLUDING BOWEL OBSTRUCTION AND ABDOMINAL PAIN. IT WAS ALSO ALLEGED THAT THE PATIENT'S LARGE INTESTINE AND COLON WERE REMOVED DUE TO INVOLUNTARY ACCIDENTS. 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: IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI CHOLECYSTECTOMY PROCEDURE PERFORMED ON (B)(6) 2013, THE PATIENT WAS FOUND TO HAVE SEPSIS ON (B)(6) 2013. ACCORDING TO THE INITIAL REPORTER, A PHYSICIAN'S ASSISTANT, THE SURGEON PERFORMED LYSIS OF ADHESIONS WITH LAPAROSCOPIC EQUIPMENT BEFORE COMPLETING THE DA VINCI SI CHOLECYSTECTOMY PROCEDURE. ON (B)(6) 2013, THE INITIAL REPORTER CHECKED ON THE STATUS OF THE PATIENT AND DISCOVERED THAT THE PATIENT HAD SEPSIS. THE PATIENT SUBSEQUENTLY UNDERWENT OPEN SURGERY ON AN UNSPECIFIED DATE AND TWO ENTEROTOMIES IN THE BOWEL WERE FOUND. THE INITIAL REPORTER INDICATED THAT THE SURGEON WAS NOT SURE HOW THE INJURIES OCCURRED. ACCORDING TO THE INITIAL REPORTER, THE SURGEON SPECULATED THAT THE INJURIES POSSIBLY OCCURRED DURING LYSIS OF THE ADHESIONS OR DURING PLACEMENT OF PORTS. THE INITIAL REPORTER INDICATED THAT THE PATIENT WAS ON A VENTILATOR AND HAD DEVELOPED RENAL FAILURE.