BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1081240 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00544
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 18, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K61095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: SIGMOIDECTOMY. ACCORDING TO THE REPORTER: STAPLES DID NOT FORM. THE INSTRUMENT FIRED AND CUT BUT STAPLES DID NOT FORM B-SHAPE. CURRENT PATIENT STATUS REPORTED AS OK. TISSUE WAS RESECTED AND THE PROCEDURE WAS CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL 12MM SINGLE USE INST DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability