BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-4.8 SULU

    MDR report key: 1082205 · Received July 25, 2008

    Report

    Report Number
    1219930-2008-00562
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE STAPLER APPEARED TO FIRE CORRECTLY. BLEEDING OCCURRED WHICH WAS CONTROLLED WITH A CLAMP. THE SURGEON OPENED THE PATIENT AND NOTED THAT THE STAPLER CUT BUT STAPLES EITHER DID NOT FORM AT ALL OR WERE MALFORMED. STAPLES FELL INTO THE CAVITY BUT ALL WERE RETRIEVED. OR TIME WAS DELAYED 2 HOURS AND THE PATIENT RECEIVED 2 UNITS OF BLOOD. PATIENT STATUS WAS REPORTED AS FINE AND WAS RELEASED IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-4.8 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8A232

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability ENDO GIA UNIVERSAL 12MM SINGLE USE INST