BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 787952 · Received November 27, 2006

    Report

    Report Number
    3005677147-2006-00002
    Event Type
    Other
    Date Received
    November 27, 2006
    Date of Event
    November 13, 2006
    Report Date
    November 22, 2006
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    PMA / PMN Number
    k991522
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT IMPACT DUE TO THE INCORRECT USE OF THE DEVICE. SHOULD AN EVENT LIKE THIS RECUR, THE POSSIBILITY OF A SERIOUS INJURY OR DEATH EXISTS. THE PACKAGING OF THE INAPPROPRIATELY SUBSTITUTED ELECTRODE USED WAS INSPECTED BY THE MFR REP AT THE FACILITY UPON DISCOVERY OF THE ERROR. ALL LABELING WAS CORRECT AND THE OR STAFF AND THE REP AGREED THAT THE ERROR WAS DUE TO THE INCORRECT SUBSTITUTION AT THE USER FACILITY, NOT AS A RESULT OF INCORRECT PACKAGING.

    Description of Event or Problem · 1

    THE WRONG MODEL MICROELECTRODE WAS USED FOR RECORDING RESULTING IN TARGET OVER-SHOOT OF APPROX 50MM. ELECTRODE REFERENCE #34680 FROM LOT 120888 WAS USED INSTEAD OF THE INTENDED MTDWBP (AR) (MP1). DURING SURGICAL SET-UP THE INCORRECT ELECTRODE WAS TAKEN TO THE OR AS A SUBSTITUTION FOR THE CORRECT ONE BECAUSE THE CORRECT ONE, WHICH WAS SPECIFIED BY REFERENCE NUMBER ON A REQUESTED EQUIPMENT LIST, WAS NOT AVAILABLE IN THE NORMAL INVENTORY. THE ERROR WAS DISCOVERED DURING OBSERVATION OF AN X-RAY TAKEN IN THE OR AFTER RECORDING AND BEFORE LEAD PLACEMENT SHOWED THE ELECTRODE TO BE MUCH DEEPER THAN EXPECTED. A SINGLE MTDWBP (AR) (MPI) WAS FOUND IN A BOX IN A STOCK SELF IN THE OR. THIS ELECTRODE WAS USED AFTER DISCOVERY OF THE ERROR. NO PT INJURY WAS REPORTED AS A RESULT OF THIS USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE DEPTH ELECTRODE GZL FHC, INC. * 120888

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other