BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 1212090 · Received October 23, 2008

    Report

    Report Number
    1219930-2008-00760
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 22, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE SULU WAS FIRED BUT FIRING STOPPED AT HALF WAY. TISSUE WAS ADDITIONALLY RESECTED TO RECOVER WITH A NEW STAPLER. NO PATIENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8B407

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability