BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3250790 · Received July 29, 2013

    Report

    Report Number
    2955842-2013-02782
    Event Type
    Death
    Date Received
    July 29, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, INTUITIVE SURGICAL INC. (ISI) CONTACTED THE SURGEON'S NURSE WHO WAS SCRUBBED IN DURING THE SURGICAL PROCEDURE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE NURSE, THE PATIENT WAS A HIGH RISK PATIENT WHO HAD HUGE CARDIOVASCULAR ISSUES. THE SURGICAL PROCEDURE TOOK ABOUT 2.5-3.0 HOURS. TOWARDS THE END OF THE SURGICAL PROCEDURE, THE SURGEON WAS IN THE PROCESS OF PLACING HIS LAST STITCH WHEN THE NEEDLE HELD BY A MEGASUTURE CUT NEEDLE DRIVER INSTRUMENT CONTROLLED BY HIS RIGHT HAND PUNCTURED A VEIN BEHIND THE PATIENT'S DIAPHRAGM. THE NURSE INDICATED THAT THE PATIENT HAD A MALFORMATION OF THE VASCULATURE BEHIND HER DIAPHRAGM AND THIS WAS ONE FACTOR AS TO WHY THE VEIN WAS PIERCED. DUE TO THE VASCULAR MALFORMATION, THE SURGEON WAS NOT EXPECTING THE VEIN TO BE PRESENT BEHIND THE PATIENT'S DIAPHRAGM. IMMEDIATELY AFTER THE VEIN WAS PIERCED, THE NURSE WAS ABLE TO CONTROL THE BLEEDING BY CLAMPING DOWN ON THE DAMAGED VESSEL WITH A LAPAROSCOPIC GRASPER INSTRUMENT. WITHIN A MINUTE OR TWO AFTER THE VESSEL WAS DAMAGED, THE SURGEON CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGICAL TECHNIQUES AS AN ATTEMPT TO REPAIR THE VEIN. THE SURGEON AND A CARDIOVASCULAR SURGEON WHO WAS PRESENT IN THE OPERATING ROOM (OR) ATTEMPTED TO REPAIR THE VESSEL. HOWEVER, THE NURSE INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED SINCE ANESTHESIA COULD NOT GET AHEAD AND KEEP UP WITH THE DEMANDS OF THE PATIENT'S CONDITION WHICH HAD RAPIDLY DETERIORATED. THE NURSE INDICATED THAT THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS WERE ANOTHER FACTOR AS TO WHY THE PATIENT'S CONDITION RAPIDLY DETERIORATED. THE NURSE INDICATED THAT NO MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. ON (B)(4) 2013, ISI CONTACTED THE RISK MANAGEMENT DEPT. AT THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE RISK MANAGER INDICATED THAT THE SURGICAL PROCEDURE WAS NOT RECORDED. SHE ALSO REVIEWED THE OPERATIVE REPORT OF THE CASE AND VERIFIED THAT THERE WAS NO NOTATION THAT A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM OCCURRED DURING THE SURGICAL PROCEDURE. THE RISK MANAGER ALSO CONFIRMED THAT THE INFORMATION PROVIDED TO ISI BY THE SURGEON'S NURSE ON (B)(6) 2013, WAS CORRECT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGICAL STAFF INDICATED THAT THE PATIENT EXPIRED DURING A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, AT THIS TIME THERE IS NO EVIDENCE THAT USER-ERROR OR A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354185 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES