BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 30-3.5 SULU

    MDR report key: 1151468 · Received September 5, 2008

    Report

    Report Number
    1219930-2008-00660
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: BULLECTOMY. ACCORDING TO THE REPORTER: STAPLES IN DISTAL END OF THE SULU WOULD NOT COME OUT. ANOTHER DEVICE WAS APPLIED TO RESECT THE STAPLE LINE AND TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 30-3.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1