BEUDAMED
    FDA Adverse Event Summary report: N

    SUCTION COAGULATOR, HAND CONTROL, 10 FR, 6", MONOPOLAR, SINGLE USE, STERILE

    MDR report key: 3094021 · Received May 6, 2013

    Report

    Report Number
    1720159-2013-00045
    Date Received
    May 6, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 6, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO CONMED CORPORATION FOR EVALUATION. THE END-USER FACILITY RISK MANAGEMENT HAS RETAINED THE DEVICE UNTIL THEY DETERMINE IF IT IS NEEDED FOR POSSIBLE LITIGATION. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE QUALITY ENGINEERING EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING A TONSILECTOMY, CAUTERY WAND BURNED THROUGH WAND AND ARCED INTO PATIENT'S MOUTH. PATIENT RECEIVED A BURN ON HIS INSIDE UPPER LIP. HE WAS GIVEN BACITRACIN AND WILL BE FOLLOWING UP WITH DOCTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196485 SUCTION COAGULATOR, HAND CONTROL, 10 FR, 6", MONOPOLAR, SINGLE USE, STERILE SUCTION COAGULATOR GEI CONMED ELECTROSURGERY 11KHL006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention