BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 1031531 · Received April 14, 2008

    Report

    Report Number
    1219930-2008-00283
    Event Type
    Injury
    Date Received
    April 14, 2008
    Report Date
    April 7, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: GASTRIC BYPASS. ACCORDING TO THE REPORTER: THE DAY AFTER THE PROCEDURE, THE PATIENT RETURNED TO SURGERY FOR A STOMACH FISTULA IN THE STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 60-3.5 SULU SURGICAL STAPLING DEVICE GDW NORTH HAVEN - USS N7L124

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention