BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL XL

    MDR report key: 525710 · Received May 18, 2004

    Report

    Report Number
    1219930-2004-00120
    Event Type
    Injury
    Date Received
    May 18, 2004
    Report Date
    April 26, 2004
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTEDLY, THE SURGEON CLAMPED THE INSTRUMENT DOWN ON TISSUE, FIRED THE INSTRUMENT, AND THE JAWS DID NOT OPEN. ANOTHER INSTRUMENT WAS REQUIRED TO CUT AROUND THE TISSUE TO RELEASE THE INITIAL INSTRUMENT AND COMPLETE THE CASE. PROCEDURE: LGB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL XL DISPOSABLE SURGICAL STAPLER GAG NORTH HAVEN - USS NA N4B434

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention