BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 45-3.5 SULU

    MDR report key: 1192440 · Received October 7, 2008

    Report

    Report Number
    1219930-2008-00712
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 19, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LUNG VOLUME REDUCTION. ACCORDING TO THE RPTR: THE INSTRUMENT WAS USED TO REMOVE A TUMOR. STAPLES DID NOT FORM CORRECTLY. THE SURGEON OVER SEWED THE STAPLE LINE. A SECOND PROCEDURE WAS PERFORMED DUE TO FISTULAS IN THE AREA OF THE STAPLE LINE WHICH RESULTED IN 10% ADD'L LUNG VOLUME LOSS. THE CURRENT CONDITION OF THE PT IS O.K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 45-3.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS N8E262

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR