BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1233967 · Received November 14, 2008

    Report

    Report Number
    1219930-2008-00829
    Event Type
    Injury
    Date Received
    November 14, 2008
    Report Date
    October 21, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: RIGHT PANCREATECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT HANDLE CRACKED 3 TIMES AND THE I-BEAM BENT. THE SURGEON WAS UNABLE TO GET THE CARTRIDGE OPEN AFTER FIRING. THEREFORE, THE INSTRUMENT WAS RESECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLER GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ENDO GIA ROTICULATOR: 45-3.5 SULU