BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ

    MDR report key: 686386 · Received March 8, 2006

    Report

    Report Number
    1527736-2006-01055
    Event Type
    Malfunction
    Date Received
    March 8, 2006
    Date of Event
    October 6, 2005
    Report Date
    March 2, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    MFJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAP REPAIR OF HIATAL HERNIA PROCEDURE, DEVICE WAS UTILIZED FOR CRURAL CLOSURE AND FIXATION. FOUR LOADS IN A ROW FIRED AND THEN THE KNOTS RELEASED INTRAOPERATIVELY. A NEW DEVICE WAS PULLED AND THE CASE COMPLETED. NO PATIENT CONSEQUENCES. NO DEVICE RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN