BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR TRIGGER - FLEX PROBE

    MDR report key: 1277652 · Received November 21, 2008

    Report

    Report Number
    2428235-2008-00014
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    PMA / PMN Number
    K003126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED BEFORE IT COULD BE RETURNED. INITIAL INVESTIGATION INDICATED THAT IF INSULATION SEPARATING FROM THE ELECTRODE FELL OFF, IT WOULD BE REMOVED THROUGH NORMAL IRRIGATION AND IS NOT LIKELY TO POSE A SAFETY RISK. TESTING WAS CONDUCTED ON REP DEVICES FROM 8 LOTS (INCLUDING THE LOT IN QUESTIONS). FUNCTIONAL TESTING INCLUDED CONDITIONS OF USE FAR BEYOND WHAT WE EXPECT TO SEE IN ACTUAL PROCEDURES AND NO SEPARATION OCCURRED. ADD'L TESTING BY OUR CONTRACT MANUFACTURE SHOWED THAT THE ONLY EVIDENCE OF INSULATION NOT PRESENT BETWEEN ELECTRODES OCCURS WHEN THE DTF-40 IS RESTERILIZED WITH A CHEMICAL STERILANT. ADD'L MEDICAL OPINION RECEIVED ON 11/18/2008, INDICATES THAT THIS IS NOT ALWAYS THE CASE; THEREFORE, ELLMAN IS SUBMITTING THIS REPORT.

    Description of Event or Problem · 1

    RICHARD WOLF REPORTED THAT IN 2008, DURING AN ENDO LUMBER DISCECTOMY PROCEDURE, THE ELECTRODE CAME OUT FROM THE SHAFT AND THE INSULATION LOOSENED BETWEEN TWO TIPS, BUT DID NOT FALL OFF. THE SITUATION WAS NOTICED BEFORE THE INSULATION FELL OFF AND THE ELECTRODE WAS REPLACED. THE SAME THING HAPPENED WITH THE SECOND ELECTRODE. THERE WERE NO REPORTED PT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR TRIGGER - FLEX PROBE GEI ELLMAN INT'L INC. DTF-40

    Patients

    Seq Age Sex Outcome Treatment
    1