BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED

    MDR report key: 898064 · Received August 15, 2007

    Report

    Report Number
    1720159-2007-00038
    Event Type
    Injury
    Date Received
    August 15, 2007
    Date of Event
    July 18, 2007
    Report Date
    August 13, 2007
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    FEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED ELECTROSURGERY RECEIVED A SUCTION COAGULATOR. ESU INTERFACE WAS PERFORMED, THE DEVICE WAS TESTED IN ALL MODES AND THE RETURNED FOOT CONTROLLED SUCTION COAGULATOR PASSED, IT OPERATED AS EXPECTED. THERE WAS NO DAMAGE OR BREAKDOWN WITH THE INSULATION. DURING THE ESU INTERFACE THE RETURNED FOOT CONTROL SUCTION COAGULATOR UNDER TEST SPARKED ONLY AT THE TIP OF THE TUBE; THIS IS EXPECTED AS DESIGNED. THE REPORTED MALFUNCTION WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    BURN JUST OUTSIDE THE RIGHT CORNER OF THE PATIENT'S MOUTH DURING A TONSILLECTOMY. DR. SEEMED TO THINK THE BURN WAS CAUSED BY INSULATION FAILURE, BECAUSE THE SUCTION COAGULATOR OFTEN RESTS ALONGSIDE THAT PART OF THE ANATOMY DURING THIS TYPE OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SUCTION COAGULATOR FEH CONMED ELECTROSURGERY 60-6900-001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other