BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX, INC.

    MDR report key: 4272092 · Received November 18, 2014

    Report

    Report Number
    3007593903-2014-00002
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 23, 2014
    Manufacturer
    BOVIE MEDICAL CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K022856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING DIAGNOSIS AND PROGNOSIS OF ANESTHESIOLOGIST'S CONDITION WERE REQUESTED BUT NOT RECEIVED. WITHOUT THIS INFORMATION IT IS NOT POSSIBLE TO CONFIRM THE CAUSE OR EXTENT OF INJURY. COMPLAINT WAS CONFIRMED FOR THERMAL DAMAGE TO GENERATOR. BEFORE OPENING COULD SMELL AN ODOR OF SMOKE. WHEN REMOVING THE TOP COVER FOUND THE 2 LONG SCREWS THAT SHOULD HAVE BEEN IN THE FRONT COVER HOLES WERE IN THE REAR HOLES ON THE COVER AND 2 SHORT SCREWS WERE IN THE FRONT HOLES. A THIRD PARTY HAS OPENED THIS UNIT BUT WE DO NOT KNOW IF IT WAS BEFORE OR AFTER THE INCIDENT. FOUND THERMAL DAMAGE TO ALL OF THE WIRES BETWEEN TRANSFORMERS T14 AND T15 IN THE FRONT RIGHT CORNER ON THE MAIN PCB WHICH ARE AT THE OUTPUT END OF THE POWER GENERATOR CIRCUIT. THE CHARRING OF THE AREA GOES THROUGH THE PCB TO THE BOTTOM SIDE WITH CHARRING AND DELAMINATION OF THE PCB. THERE WERE NOT ANY LOOSE COMPONENTS FOUND IN THE UNIT, ALL SCREWS AND HEATSINK CLIPS ARE SECURE AND PRESENT. WITH THE DAMAGE TO THE AREA IT IS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE OF THE DAMAGE. (B)(4).

    Description of Event or Problem · 1

    WHILE DOING A KNEE SCOPE THE CONSOLE STARTED SMOKING. THE CONSOLE WAS REMOVED FROM THE ROOM. WHEN THE SALES REP CHECKED THE DEVICE THE SETTINGS WERE SET AT 150 AND 50. IT WAS REPLACED AND THE CASE COMPLETED. NO PATIENT INJURY. UPDATED 10/23/2014: THE ANESTHESIOLOGIST REPORTED SHE HAD A SORE THROAT AFTER SHE UNPLUGGED THE CONSOLE DURING THIS INCIDENT WHERE THE CONSOLE BEGAN SMOKING IN THE ROOM. SHE WENT TO THE E.R AND WAS TOLD SHE HAS A CHEMICAL BURN TO HER THROAT BELIEVED TO BE CAUSED BY INHALING THE SMOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744599 ARTHREX, INC. ELECTROSURGICAL GENERATOR GEI BOVIE MEDICAL CORPORATION AR-9600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention