BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2269019 · Received September 29, 2011

    Report

    Report Number
    2955842-2011-00313
    Event Type
    Death
    Date Received
    September 29, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 30, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE SURGEON WHO PERFORMED THE TORS PROCEDURE INFORMED INTUITIVE SURGICAL THAT THEY WERE ADVISED NOT TO PROVIDE ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 56 HOURS AFTER A DA VINCI SI TORS (TRANSORAL ROBOTIC SURGERY) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPERIENCED HEAVY BLEEDING AND CARDIOPULMONARY ARREST ENSUED. CPR WAS PERFORMED IN EXCESS OF 20 MINUTES BEFORE THE PATIENT'S PULSE WAS RESTORED AND AS A RESULT, IRREVERSIBLE ANOXIC BRAIN INJURY OCCURRED. ON (B)(6) 2011, THE PATIENT EXPIRED. AT THE TIME OF THE REPORT, THE CAUSE OF THE PATIENT BLEEDING WAS UNDETERMINED. IT WAS ALSO REPORTED THAT DURING THE SURGICAL PROCEDURE, THERE WERE NO SYSTEM FAILURES, NO INJURY TO THE PATIENT, AND NO COMPLICATIONS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death DA VINCI SI INSTRUMENTS AND ACCESSORIES