BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED CORPORATION

    MDR report key: 478339 · Received August 12, 2003

    Report

    Report Number
    1720159-2003-00076
    Event Type
    Malfunction
    Date Received
    August 12, 2003
    Date of Event
    July 11, 2003
    Report Date
    July 14, 2003
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPCHOLI, THE PENCIL WAS LAYING ON THE PATIENT AND THE LAPARASCOPIC INSTRUMENT WAS TO BE ACTIVATED VIA THE FOOTSWITCH. WHEN THE FOOTSWITCH WAS STEPPED ON, BOTH THE LAPARASCOPIC INSTRUMENT AND THE PENCIL WERE ACTIVATED. THIS WAS NOTICED RIGHT AWAY AND THE PENCIL WAS MOVED. THE PATIENT RECEIVED A 1ST DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED CORPORATION ELECTROSURGICAL UNIT GEI CONMED ELECTROSURGERY EXCALIBUR PLUS PC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA HANDTROL