BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHT ANGLE CUTTING LOOP ELECTRODE

    MDR report key: 2191319 · Received July 27, 2011

    Report

    Report Number
    3006159227-2011-00006
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 27, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE RIGHT ANGLE CUTTING LOOP ELECTRODE, THE YELLOW PLASTIC INSULATION COVER OF THE ELECTRODE DETACHED FROM THE ELECTRODE AND FELL OFF INTO THE PT. THIS HAPPENED 3 TIMES WITH 3 DIFFERENT ELECTRODES FROM THE SAME LOT. A LOOP FROM A DIFFERENT LOT WAS USED TO FINISH THE CASE. PIECES WERE TAKEN OUT WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGHT ANGLE CUTTING LOOP ELECTRODE RIGHT ANGLE CUTTING LOOP ELECTRODE HIH GYRUS ACMI, INC. MLE-24-012 2047061C

    Patients

    Seq Age Sex Outcome Treatment
    1