BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL XL

    MDR report key: 1844803 · Received September 22, 2010

    Report

    Report Number
    2647580-2010-00780
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE RPTR: THE SULU WAS FIRED AND RESULTED IN A HANDLE CRACK ON THE FIRST HANDLE SQUEEZE. STAPLES DID NOT FORM PROPERLY. ANOTHER RELOAD WAS PLACED JUST LATERAL TO THE CUT LINE OF THE MISFIRED RELOAD AND WAS FIRED SUCCESSFULLY. SIGNIFICANT BENDING OF THE ANVIL CAN BE SEEN. THE STAPLE LINE WAS OVER-SEWED WHICH EXTENDED SURGERY TIME BY 30 TO 45 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL XL DISPOSABLE STAPLER GDW USSC PUERTO RICO N0E212

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other MANUFACTURE DATE: 07/2008| LOT NUMBER: N8G458, EXPIRATION DATE: 07/31/2013,| ENDO GIA II 60-4.8 SULU, 030415,