BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDO GIA II

    MDR report key: 287394 · Received July 19, 2000

    Report

    Report Number
    MW1019378
    Event Type
    Other
    Date Received
    July 19, 2000
    Date of Event
    July 14, 2000
    Report Date
    July 19, 2000
    Manufacturer
    USSC AUTO SUTURE CO.
    Product Code
    GAG
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCHEDULED FOR PALLIATIVE SURGERY VIA LAPAROSCOPY. ENDO GIA STAPLER GUNS MALFUNCTIONED X3 REQUIRING CONVERSION TO LAPAROTOMY. ALL FROM SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II DISPOSABLE STAPLER GAG USSC AUTO SUTURE CO. 030402 N0C115

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other