BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR TRIGGER-FLEX PROBE

    MDR report key: 1237221 · Received November 5, 2008

    Report

    Report Number
    2428235-2008-00008
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ELLMAN INT'L., INC.
    Product Code
    GEI
    PMA / PMN Number
    K003126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS RECEIVED ON 10/06/08. THE RETURN PRODUCT WAS RECEIVED BY ELLMAN INTL ON 11/05/08. THE SEPARATED ELECTRODE WAS NOT RETURNED WITH THE PRODUCT. THE DISTRIBUTOR HAS STATED THAT NO ADDITIONAL DATA IS AVAILABLE. EVALUATION OF PRODUCT AT THIS TIME IS THAT THE ELECTRODE SEPARATED FROM THE WIRE IN THE SHAFT. THE REMAINING ELECTRODE IS FIRMLY ATTACHED.

    Description of Event or Problem · 1

    IN 2008, A LUMBAR RHIZOTOMY WAS PERFORMED WHERE THE LOWER ELECTRODE FELL OFF THE DTF-40 BIPOLAR HAND PIECE. THE ELECTRODE WAS RETRIEVED WITH NO DELAY IN SURGERY AND THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR TRIGGER-FLEX PROBE GEI ELLMAN INT'L., INC. 080101294

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other