BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 2443765 · Received January 23, 2012

    Report

    Report Number
    3007593903-2012-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Report Date
    January 23, 2012
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    HRX
    PMA / PMN Number
    K020579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED AS TO MISSING TIP. THE TIP OF THE ELECTRODE IS COMPLETELY BURNED, WHICH IS A RESULT OF MELTING. IT THAT THE DEVICE WAS EITHER USED AT AN EXTREMELY HIGH POWER SETTING OR THE DEVICE SHORTED ON A GROUNDED DEVICE USED IN THE PROCEDURE AND CREATED AN ARC. THE FRONT INSULATION IS ALSO COMPLETELY MISSING AND APPEARS TO BE PARTIALLY BURNED INTO THE METAL SUBSTRATE. THE INSULATION RESISTS BURNING AT VERY HIGH TEMPERATURE. THE STAINLESS STEEL ELECTRODE TIP IS NOT EASILY BROKEN BY FORCE. IT REQUIRES A GREAT DEAL OF FORCE OR DEFORMING THE TIP IN ORDER TO BREAK IT. IT CANNOT BE DONE WITHOUT THE USE OF TOOLS SUCH AS PLIERS. IT IS NOT POSSIBLE TO MELT THE STAINLESS STEEL TIP BY ANY OTHER MEANS, SINCE IT REQUIRES A TEMPERATURE OF APPROXIMATELY 1500 DEGREES C. THE LIKELY ROOT CAUSE IS EXTENDED ACTIVATION OF THE DEVICE WHILE IT WAS IN CONTACT WITH ANOTHER GROUNDED DEVICE.

    Description of Event or Problem · 1

    A PT WAS UNDERGOING A LUMBAR LAMINECTOMY. AT THE BEGINNING OF THE PROCEDURE, THE SURGEON NOTICED THAT A SMALL PIECE OF THE TIP WAS MISSING. THE MISSING PIECE WAS NOT VISIBLE AND WAS IDENTIFIED VIA X-RAY. THE SURGEON REMOVED THE PIECE WITHOUT TRAUMA TO THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE MEDICAL ARTHROSCOPIC ELECTRODE HRX BOVIE MEDICAL CORPORATION 0811-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention