BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOSUTURE

    MDR report key: 469841 · Received July 3, 2003

    Report

    Report Number
    MW1028903
    Event Type
    Death
    Date Received
    July 3, 2003
    Date of Event
    May 9, 2003
    Report Date
    July 3, 2003
    Manufacturer
    TYCO HEALTH CARE UNITED STATES SURGICAL
    Product Code
    GDO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LAPAROSCOPIC CHOLECYSTECTOMY AND DISCHARGED SAME DAY. FOUND UNCONSCIOUS AT HOME LATER IN EVENING. TAKEN TO ANOTHER FACILITY AND TO O.R. WITH FINDING OF INTRABDOMINAL BLEED. AFTER THOROUGH ROOT CAUSE ANALYSIS CONCERN EXISTS THAT SURGICAL CLIPS MAY HAVE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE ENDO CLIP II 10MM GDO TYCO HEALTH CARE UNITED STATES SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| R