BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA II 45-3.5 DLU

    MDR report key: 1092503 · Received August 1, 2008

    Report

    Report Number
    1219930-2008-00577
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 31, 2008
    Manufacturer
    NORTH HAVEN-USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: OPEN) SUB TOTAL GASTRECTOMY. ACCORDING TO THE REPORTER: WHEN FIRED ACROSS DUODENUM, A PART OF THE INSTRUMENT FELL INTO CAVITY MAKING A CRACKING NOISE. THE FIRING WAS COMPLETED BUT SOME STAPLES WERE MALFORMED. THE PART WAS RETRIEVED AND TISSUE WAS RESECTED WITH A NEW STAPLER TO RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA II 45-3.5 DLU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN-USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability