BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEI

    MDR report key: 1313545 · Received February 18, 2009

    Report

    Report Number
    1527736-2008-02608
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    April 28, 2008
    Report Date
    May 3, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A LAP GASTRIC BYPASS PROCEDURE, UPON TRYING TO FIRST ACTIVATE THE INSTRUMENT, A SOLID TONE OCCURRED. THE TECH RETIGHTENDED THE INSTRUMENT, SAME TONE. THESE STEPS WERE REPEATED WITH A SECOND PIECE WITH THE SAME RESULTS. FINALLY, A THIRD INSTRUMENT WAS USED. THERE WAS NO REPORTED PATIENT CONSEQUENCE AND TWO DEVICES HAVE BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEI GEI ETHICON ENDO SURGERY, INC. (CINCINNATI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1