BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOVIE MEDICAL CORPORATION

    MDR report key: 5904598 · Received August 25, 2016

    Report

    Report Number
    3007593903-2016-00008
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    July 26, 2016
    Report Date
    August 26, 2016
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K000961
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS NOT CONFIRMED FOR A PROBLEM WITH THE UNIT CAUSING THE REPORTED PATIENT BURN. TESTING THE UNIT IN THE AS RECEIVED CONDITION USING THE CUSTOMER'S RETURNED FOOTSWITCH FOUND THE UNIT PASSED ALL PARAMETERS PER CURRENT BOVIE MEDICAL TEST PROCEDURES. WHEN TESTING THE OUTPUTS AT LINE INPUT VOLTAGES OF 120 VOLTS AND 240 VOLTS, THE OUTPUTS WERE THE SAME AS BOTH INPUT VOLTAGES. THE UNIT PASSED ALL FUNCTIONAL TESTING AND FOUND ACCEPTABLE FOR USE. A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT SHOW ANY FAILURES DURING THE MANUFACTURING OR INSPECTION PROCESSES. A SEARCH FOR SIMILAR COMPLAINTS RESULTED IN NO PRIOR REPORTED INCIDENTS. THIS IS THE FIRST OCCURRENCE FOR THIS TYPE OF FAILURE MODE WITH THE A940 GENERATOR AND AN A802EU BROKEN PATIENT PLATE. VISUAL INSPECTION OF THE RETURNED A802EU PATIENT PLATE SHOWS THE CORNER IS BENT WHERE THE GROUNDING PIN ATTACHES AND THE GROUNDING PIN IS NOT ATTACHED TO THE PLATE. IF THE PIN BECAME DETACHED DURING SURGERY, THIS MAY BE THE CAUSE FOR THE PATIENT BURN BY CREATING A REDUCED CONTACT AREA OF LESS THAN 3" BY 1" INSTEAD OF SIZE OF THE PLATE 4" BY 4". TWO ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORTED COMPLAINT WITH NO RESPONSE AS OF THIS REPORT DATE. A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS THE GROUNDING PIN BROKE DURING THE PROCEDURE. IF THIS HAPPENED DURING SURGERY, ANYWHERE THE PIN TOUCHED WOULD HAVE HAD THE POTENTIAL TO CAUSE A BURN SINCE THE CONTACT AREA WOULD HAVE BECOME VERY SMALL AND WOULD NOT HAVE DISPERSED THE RF ENERGY CORRECTLY.

    Description of Event or Problem · 1

    PATIENT RECEIVED A BURN USING AN A940 GENERATOR AND AN A802EU BOVIE PATIENT PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556031 BOVIE MEDICAL CORPORATION A940 40 WATT HIGH FREQUENCY GENERATOR GEI BOVIE MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1