BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1100886 · Received August 6, 2008

    Report

    Report Number
    1219930-2008-00589
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 6, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: SPLENECTOMY. ACCORDING TO THE REPORTER: ON THE FIRST FIRING ACROSS THE SPLENIC ARTERY, THE INSTRUMENT RESECTED BUT WOULD NOT RELEASE TISSUE. REPORTEDLY, THE CARTRIDGE AND STAPLER WERE NOT CONNECTED PROPERLY. THE INSTRUMENT WAS REMOVED BY RESECTION WITH ANOTHER DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Disability ENDO GIA ROTICULATOR 45-2.0 SULU