BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 60-3.5 SULU

    MDR report key: 1140278 · Received August 29, 2008

    Report

    Report Number
    1219930-2008-00651
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 27, 2008
    Report Date
    August 29, 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
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: ROUX-EN-Y. ACCORDING TO THE REPORTER: UPON FIRING ACROSS PYLORUS, THE CLAMP BAR BROKE AND THE JAWS OPENED. TISSUE WAS PARTIALLY STAPLED BUT MOST OF THE TISSUE REMAINED UNCUT. A ROTICULATOR 60-4.8MM SULU WAS FIRED ON THE ANAL SIDE TO RECOVER. LESS THAN 200CC BLEEDING WAS REPORTED. PATIENT STATUS REPORTED AS OK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability