BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1212100 · Received October 24, 2008

    Report

    Report Number
    1219930-2008-00763
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 23, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE JAWS DID NOT OPEN AFTER FIRING. THE INS WAS RESECTED WITH ANOTHER INSTRUMENT. THERE WAS BLEEDING BUT NO TRANSFUSION WAS NEEDED. SURGERY TIME WAS EXTENDED BY 90 MINUTES.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 030458