BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOVIE MEDICAL

    MDR report key: 2582779 · Received May 18, 2012

    Report

    Report Number
    3007593903-2012-00002
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K001955
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED SIMULATED USE TESTING OF ELECTROSURGICAL GENERATOR, FOOTSWITCH, AND CUSTOMER'S BUGBEE ELECTRODE IN THE AS-RETURNED CONDITION. ACTIVATED THE GENERATOR (WITH FOOTSWITCH AND ELECTRODE ATTACHED) MULTIPLE TIMES WITH BOTH SHORT AND LONG ACTIVATIONS (UP TO 2 MINUTES). 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 HIGH FREQUENCY GENERATOR GEI BOVIE MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BUGBEE ELECTRODE| FOOTSWITCH (BV-1253B)