BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 30-2.5 SULU

    MDR report key: 1081263 · Received July 23, 2008

    Report

    Report Number
    1219930-2008-00548
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 23, 2008
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LOBECTOMY. ACCORDING TO THE REPORTER: THE DEVICE WAS USED FOR RESECTING THE PULMONARY ARTERY. ON THE THIRD FIRING, STAPLES IN THE DISTAL END OF THE SULU (ABOUT 1 CM IN LENGTH) WOULD NOT COME OUT, ONLY KNIFE BLADE MOVED FORWARD. OVER 200CC UNDER 500CC BLEEDING OCCURRED. THE INCOMPLETE STAPLE LINE WAS SUTURED MANUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 30-2.5 SULU DISPOSABLE STAPLING DEVICE GDW NORTH HAVEN - USS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other