BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENNIS BIPOLAR SUBMUCOSAL TURBINATE PROBE

    MDR report key: 730370 · Received June 23, 2006

    Report

    Report Number
    730370
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    May 15, 2006
    Report Date
    June 23, 2006
    Manufacturer
    ELMED, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS DISSECTING PATIENT'S SOFT PALATE USING BIPOLAR CAUTERY WHEN NURSE POINTED OUT THAT THE BIPOLAR CAUTERY HAD CONTACTED THE PATIENT'S UPPER LIP AND GIVEN A LOCAL BURN. THERE WAS ALSO ANOTHER BURNED AREA NOTED ON THE UPPER LIP JUST TO THE RIGHT SIDE OF THE MIDLINE. CARE WAS TAKEN THEREAFTER TO ASSURE THAT THE LIP WAS FULLY PROTECTED. SURGEON NOTED THAT THE BIPOLAR CAUTERY INSTRUMENT ITSELF WAS DEEMED TO BE FUNCTIONING PROPERLY. HOWEVER, THERE WAS NO INSULATION ON THE HANDLE PORTION OF THIS BIPOLAR CAUTERY. MEDICAL EXAM NOTES: MINOR THERMAL BURNS ON UPPER MIDLINE LIP AND RIGHT LATERAL LIP - APPEAR TO BE STAGE 1-TYPE BURN WITH NO BLISTERING NOTED. ELMED BIPOLAR DENNIS PROBE WAS SENT OUT FOR SERVICE (CHIP WAS NOTICED IN THE INSULATION AT THE BASE OF THE BAYONET NEEDLE MOUNT). INSPECTION REVEALED HANDLE SLIGHTLY DISCOLORED, BAYONET ELECTRODES BENT OUT OF SHAPE, AND THE INSULATION DAMAGED. SERVICE CONSISTED OF DISASSEMBLING THE INSTRUMENT, INSULATION STRIPPED, ELECTRODES STRAIGHTENED, REINSULATED AND REASSEMBLED. UNIT TESTED AND RETURNED. BIOMED INSPECTED/TESTED THE ELECTROSURGERY UNIT AND REPAIRED A FRAYED POWER PLUG AND RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENNIS BIPOLAR SUBMUCOSAL TURBINATE PROBE PROBE, CAUTERY GEI ELMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR