BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA UNIVERSAL 12MM SINGLE USE INST

    MDR report key: 1040579 · Received May 9, 2008

    Report

    Report Number
    1219930-2008-00362
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 2, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: WHEN ATTEMPTING TO FIRE THE STRAIGHT 45-2.5 LOAD ACROSS THE RENAL VESSELS, THE INSTRUMENT GAVE OFF A LOUD "CRACKING SOUND" AND THE STAPLE LOAD FELL INSIDE THE PT WITHOUT PROPERLY FORMING THE STAPLES. INCOMPLETE STAPLING AND TRANSECTION OF THE RENAL VESSEL RESULTED IN UNANTICIPATED BLEEDING. THE SURGEON CONVERTED TO AN OPEN PROCEDURE TO STOP THE BLEEDING AND RETRIEVE THE PARTS THAT FELL INTO THE PT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention 030425