BEUDAMED
    FDA Adverse Event Other Summary report: N

    XL TEK EVOKED POTENITAL HEADBOX

    MDR report key: 622690 · Received July 19, 2005

    Report

    Report Number
    9612330-2005-00001
    Event Type
    Other
    Date Received
    July 19, 2005
    Date of Event
    June 14, 2005
    Report Date
    July 15, 2005
    Manufacturer
    EXCEL TECH. LTD.
    Product Code
    GWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING A SPINAL CORD (THORACI TUMOR CASE-2 POST TIBIAL NERVE, RIGHT MEDIAN), PT UNDERWENT 3 EXTREMITY SSEP TESTING. PT WAS PLACED IN PRONE POSITION FOR CASE WITH IOM NEEDLE ELECTRODES PLACED TO SCALP AND BILATERAL CHEST WALL. DURING CLOSING, A 1.5 CM DIAMETER SKIN LESION WAS NOTED ON L) FOREHEAD WHERE GROUND OR FPZ ELECTRODE WAS. ALSO NOTED 4 LESIONS ON CHEST. LESIONS SITES WERE GRAY WITH RED OUTLINE.

    Description of Event or Problem · 1

    THE ELECTROSURGERY DEVICE CURRENT MAY HAVE ESTABLISHED AN ALTERNATE RETURN PATH THAT MAY HAVE RESULTED IN HIGH CURRENT DENSITY PASSING THROUGH THE SUBDERMAL NEEDLE ELECTRODES WITH THE POSSIBLE TISSUE HEATING AND DAMAGE RESULTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XL TEK EVOKED POTENITAL HEADBOX EVOKED POTENTIAL DIAGNOSTIC DEVICE GWF EXCEL TECH. LTD. EP16 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other