BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE FULGURATING ELECTRODE

    MDR report key: 2426234 · Received January 13, 2012

    Report

    Report Number
    1519132-2011-00034
    Event Type
    Other
    Date Received
    January 13, 2012
    Date of Event
    December 8, 2011
    Report Date
    December 14, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FBO
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THIS UNIT, VISUAL INSPECTION OF THE ELECTRODE CONFIRMS THAT THE TIP CAME OFF. TIP OBSERVATIONS: AS NOTED IN THE PROXIMAL END OF THE TIP SHOWS SIGNS OF SEVERE OVERHEATING/BURNING, WHICH IS COINCIDENT WITH THE CAVITY THA ACCOMMODATES THE WIRE TIP. IT IS ALSO NOTED THE ITP IS FOUND TO BE SEVERELY DEFORMED. GREEN INSULATION REVIEW: THE GREEN INSULATION EXHIBITS A SMALL AMOUNT OF MELTING AT THE DISTAL END AND THERE IS BLACK RESIDUE REMAINING INSIDE THE INSULATION COINCIDENT WITH THE BURN MARKS ON THE TIP SHAFT ITSELF. WIRE OBSERVATIONS: THE WIRE HAS RESIDUAL SOLDER ON THE DISTAL END WHERE IT HAD PREVIOUSLY BEEN INSERTED INTO THE BALL SHAFT. A SEARCH OF PRIOR INCIDENTS FOR THIS TYPE OF INSTRUMENT WAS PERFORMED WITH THE SAME OR SIMILAR DESCRIPTION IN THE PROBLEM STATEMENT, NONE WAS FOUND. THE ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED WITH THE EVIDENCE AND DESCRIPTION PROVIDED. HOWEVER, BASED ON THE DISCOLORATION/BURN AREA ON THE BALL SHAFT AND THE RESIDUAL SOLDER ON THE WIRE, IT CAN BE ASSERTED THAT THE INSTRUMENT WAS PROPERLY ASSEMBLED AT THE TIME OF MANUFACTURE BUT EXPERIENCED AN ATYPICAL ELECTRICAL EVENT DURING USE CAUSING THE OBSERVED DAMAGE. GYRUS ACMI WILL CONTINUE TO MONITOR THE RETURN OF SUBSEQUENT DEVICES FOR ADVERSE TRENDS.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE ELECTRODE WE WERE INFORMED THAT THE TIP CAME OFF IN THE PT'S BLADDER. IT WAS RECOVERED WITHOUT INCIDENT AND WILL BE RETURNED FOR EVALUATION. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE FULGURATING ELECTRODE FLEXIBLE FULGURATING ELECTRODE FBO GYRUS ACMI, INC. 253F6 JO

    Patients

    Seq Age Sex Outcome Treatment
    1