BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL XL

    MDR report key: 1233964 · Received November 14, 2008

    Report

    Report Number
    1219930-2008-00830
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 13, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: BYPASS. ACCORDING TO THE REPORTER: THE DLU JAMMED ON THE SMALL INTESTINE. THE SURGEON RESECTED TO RELEASE THE INSTRUMENT AND DO 2 ANASTOMOSIS. PT STATUS REPORTED AS OK AND HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL XL DISPOSABLE STAPLER GDW NORTH HAVEN - USS N8E150

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability ENDO GIA II: 45-2.5 DLU