BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 2604430 · Received June 6, 2012

    Report

    Report Number
    3007593903-2012-00003
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Report Date
    May 18, 2012
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY INSPECTED THE FOOTSWITCH PEDAL AND SPRINGS IN THE AS-RETURNED CONDITION. COULD NOT FIND ANY OBSTRUCTIONS OR LOOSE SPRINGS THAT WOULD CAUSE THE REPORTED NON CONFORMANCE. PERFORMED ADDITIONAL TESTING OF FOOTSWITCH, ELECTROSURGICAL GENERATOR, AND CUSTOMER'S BUGBEE ELECTRODE IN THE AS-RETURNED CONDITION. ACTIVATED THAT GENERATOR (WITH FOOTSWITCH AND ELECTRODE ATTACHED) MULTIPLE TIMES WITH BOTH SHORT AND LONG ACTIVATIONS (UP TO 2 MINS). THE FOOTSWITCH OPERATED AS INTENDED SINCE THE GENERATOR STOPPED ACTIVATING EVERY TIME THE FOOTSWITCH WAS RELEASED.

    Description of Event or Problem · 1

    SURGEON WAS REMOVING A CYST FROM THE BLADDER. THEY CAUTERIZED 2-3 TIMES. ON THE FOURTH ATTEMPT, THE FOOTSWITCH PEDAL GOT STUCK AND THE ELECTRODE HAD TO BE REMOVED FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOVIE MEDICAL FOOTSWITCH GEI BOVIE MEDICAL CORPORATION 0811-4

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HIGH FREQUENCY GENERATOR (A1250U)| BUGBEE ELECTRODE