BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE/BIPOLAR

    MDR report key: 1800926 · Received August 9, 2010

    Report

    Report Number
    MW5017060
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 9, 2010
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON ASSISTANT NOTED A CONTINUOUS BEEPING SOUND, UPON ASSESSMENT, THE SOUND WAS COMING FROM THE BOVIE, WHICH WAS HAND HELD AND NO ONE WAS FIRING IT. THE BOVIE MACHINE WAS REMOVED AND ANOTHER ONE REPLACED IT. GENERAL SURGEON WAS CONSULTED TO CONFIRM LOCAL BURN SITE TO THE BOWEL OF THE PT. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: RIGHT ADRENAL MASS. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE/BIPOLAR NONE GEI VALLEYLAB F5C36960A T8E650E14202

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability