BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3849877 · Received June 4, 2014

    Report

    Report Number
    2955842-2014-03460
    Event Type
    Death
    Date Received
    June 4, 2014
    Date of Event
    August 9, 2011
    Report Date
    May 5, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT HAS BEEN DETERMINED THAT THE DEMISE OF THE PATIENT WAS NOT CAUSED BY THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES BUT RATHER DUE TO THE PATIENT'S CONDITION. ISI HAS CONTACTED THE SITE'S RISK MANAGEMENT TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THE DOCUMENTATION PROVIDED DID NOT CONTAIN ANY ALLEGATION OF A MALFUNCTION OF A DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: POST A DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT EXPERIENCED POST-SURGICAL COMPLICATIONS AND SUBSEQUENTLY EXPIRED. THERE WAS NO INDICATION THAT THE PATIENT'S DEMISE WAS CAUSED BY THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES.

    Description of Event or Problem · 1

    AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY FOR ABNORMAL UTERINE BLEEDING, MENORRHAGIA, UTERINE HYPERTROPHY, UTERINE FIBROIDS, AND COMPLEX ENDOMETRIAL HYPERPLASIA WITH ATYPICAL ON (B)(6) 2011. ISI WAS PROVIDED WITH THE PATIENT OPERATIVE (OP) REPORT PERTAINING TO HER DA VINCI HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, MEDICAL DOCUMENTATION PERTAINING HER PRE-SURGICAL CONDITION, AND CARDIAC CLEARANCE. ISI WAS ALSO PROVIDED MEDICAL DOCUMENTATION PERTAINING TO HER HOSPITALIZATION FROM (B)(6) 2011, THE DATE THE PATIENT DIED AND HER CERTIFICATE OF DEATH. THE PATIENT'S RECORDS HAVE BEEN EXTENSIVELY REVIEWED. ACCORDING TO THE INFORMATION PROVIDED IN THE PATIENT'S OP REPORT FOR HER DA VINCI SURGICAL PROCEDURE ON (B)(6) 2011, THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES; HOWEVER, IT WAS INDICATED THAT THE SURGERY WAS COMPROMISED BY THE PATIENT'S HABITUS AND HER EXTREME OBESITY, WHICH REQUIRED ADDITIONAL OPERATING TIME IN PRE-HYSTERECTOMY AND HYSTERECTOMY PORTIONS OF THE PROCEDURE. ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED DUE TO INTRACTABLE NAUSEA AND VOMITING. A CT SCAN PERFORMED ON THE PATIENT SHOWED THAT THE PATIENT'S HERNIA (PRE-EXISTING) WAS CHRONIC AND THERE WAS SMALL IN IT. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY. IT WAS DISCOVERED THAT THE PATIENT HAD A LARGE HERNIA WITH A LOT OF INCARCERATED BUT NOT STRANGULATED SMALL BOWEL, AND THERE WAS A VERY SMALL HOLE IN HER SMALL BOWEL AND THAT THERE WAS A PINHOLE-TYPE LEAK RIGHT AT THE MESENTERIC BORDER OF THE SMALL BOWEL. ABDOMINAL WALL DEBRIDEMENT WAS PERFORMED AND THE HERNIA AND PATIENT'S SMALL BOWEL WERE REPAIRED. ON (B)(6) 2011, THE PATIENT UNDERWENT DEBRIDEMENT OF HER LAPAROTOMY WOUND AND PLACEMENT OF A WOUND VAC SPONGE. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY/ EXTENSIVE LYSIS OF ADHESIONS WITH 1 SMALL-BOWEL RESECTION AND 1 INCIDENTAL APPENDECTOMY. ON (B)(6) 2011, THE PATIENT UNDERWENT A TRACHEOSTOMY, A DEBRIDEMENT OF HER ABDOMINAL WALL, IRRIGATION OF HER ABDOMINAL CAVITY, AND AN OVER SEWING OF A SEROMUSCULAR TEAR AND SMALL BOWEL. A WOUND VAC WAS ALSO PLACED. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, A PERITONEAL LAVAGE AND PLACEMENT OF A WOUND VAC ON (B)(6) 2011, THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT OF HER OPEN ABDOMEN AND A WOUND VAC AS PLACED. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, PERITONEAL LAVAGE, REPAIR OF A SMALL BOWEL PERFORATION AND THE APPLICATION OF A WOUND VAC. ON (B)(6) 2011, THE PATIENT UNDERWENT PLACEMENT OF LEFT INTERNAL JUGULAR VEIN TUNNELED HICKMAN CATHETER, AN EXPLORATORY LAPAROTOMY, AND PLACEMENT OF A WOUND VAC. ON (B)(6) 2011, THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY, PERITONEAL LAVAGE REPAIR OF VENTRAL HERNIAS, A PANNICULECTOMY, A BILATERAL EXTERNAL OBLIQUE AND A POSTERIOR RECTUS SHEATH COMPONENT RELEASE FOR AN OPEN ABDOMEN CLOSURE. ON (B)(6) 2011, THE PATIENT UNDERWENT A RIGHT INTERNAL JUGULAR VEIN PERMCATH PLACEMENT PROCEDURE AND AN INTRAOPERATIVE BRONCHOSCOPY FOR CHRONIC RENAL FAILURE. ON (B)(6) 2011, THE PATIENT UNDERWENT DEBRIDEMENT OF A NECROTIC WOUND AND PLACEMENT OF A WOUND VAC. IN THE PATIENT'S DISCHARGE SUMMARY DATED (B)(6) 2011, IT WAS STATED, THE NURSE WAS IN THE ROOM WITH HER WHEN SHE ROLLED HER EYES BACK IN HER HEAD, VOMITED, ASPIRATED, AND HAD TO BE CODED. I WAS ACTUALLY AT HOME AT THE TIME BUT WHEN NOTIFIED CAME STRAIGHT IN. AT THE TIME I ARRIVED, THEY HAD BEEN GOING THROUGH THE ACLS PROTOCOLS FOR ABOUT 45 MINUTES. BECAUSE OF HER HISTORY OF RENAL FAILURE, WE DID GIVE HER CALCIUM, AND SHE GOT BACK HER PULSE AND BLOOD PRESSURE. SHE WAS ULTIMATELY TRANSFERRED TO THE ICU. SHE HAD A TRACHEOSTOMY IN PLACE AND WAS VENTILATED THROUGH THAT BUT DID NOT SHOW ANY SIGN OF IMPROVEMENT, HAD IRREGULAR ASYMMETRIC BLOWN PUPILS, AND DID NOT HAVE ANY CORNEAL REFLEXES OR SIGNS OF BRAIN FUNCTION. LATER THAT DAY, HER BLOOD PRESSURE AGAIN BOTTOMED OUT, AND THIS TIME, HER FAMILY ASKED THAT WE WITHHOLD TREATMENT, AND SHE EXPIRED. THE PATIENT EXPIRED ON (B)(6) 2011. ACCORDING TO THE INFORMATION IN THE PATIENT'S CERTIFICATE OF DEATH, THERE WAS NO AUTOPSY PERFORMED ON THE PATIENT. IT WAS INDICATED THAT THE CAUSE OF THE PATIENT'S DEMISE WAS DUE TO A PERFORATED SMALL BOWEL AND A VENTRAL HERNIA AND THAT THE PATIENT'S MORBID OBESITY WAS A SIGNIFICANT CONDITION THAT CONTRIBUTED TO THE PATIENT'S DEMISE. ACCORDING TO THE INFORMATION IN THE PATIENT'S CERTIFICATE OF DEATH, THE PATIENT'S MANNER OF DEATH WAS DOCUMENTED AS NATURAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326492 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R