BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE

    MDR report key: 2003114 · Received February 7, 2011

    Report

    Report Number
    2003114
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 7, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF CASE, THE BOVIE MACHINE MADE A CONTINUOUS LOUD NOISE WITHOUT ANYBODY ACTIVATING IT. TRIED TO UNPLUG IT, BUT SUDDENLY THE BOVIE MACHINE STARTED TO EXHIBIT BLACK SMOKE OUT OF THE BACK OF THE MACHINE. SURGEON WAS IN THE ROOM WHEN THIS INCIDENT HAPPENED. NO UNTOWARD EFFECT SEEN ON THE PATIENT. BOVIE MACHINE WAS SENT TO BIOMED WITH ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE BOVIE MACHINE GEI COVIDIEN BV1403007 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *