BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAVO

    MDR report key: 1047982 · Received May 16, 2008

    Report

    Report Number
    2126317-2008-00001
    Event Type
    Other
    Date Received
    May 16, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 18, 2008
    Manufacturer
    NICOLET BIOMEDICAL (AKA VIASYS NEUROCARE; CARDINAL HEALTH 209)
    Product Code
    GWF
    PMA / PMN Number
    K991054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING 'POSTERIOR THORACO-LUMBAR SPINE FUSION' PROCEDURE WHILE ELECTRO SURGERY WAS BEING PERFORMED, TWO SMALL DARK CIRCLE BURN MARKS RESULTED AT THE SITE OF THE RECORDING ELECTRODES AROUND THE NEEDLE ENTRY POINTS ON THE KNEE. NO MEDICAL INTERVENTION WAS REQUIRED. INSPECTION AND TEST OF THE VIASYS (CARDINAL HEALTH 209) DEVICES SHOWED NO MALFUNCTION OR COMPROMISE OF SAFETY FEATURES. OTHER CONTRIBUTING FACTORS THAT POTENTIALLY AFFECTED THE OUTCOME ARE THE USE OF ELECTRO SURGERY DEVICE (NON VIASYS DEVICE) WERE BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO EVOKED POTENTIAL-ELECTROENCEPHALOGRAPH GWF NICOLET BIOMEDICAL (AKA VIASYS NEUROCARE; CARDINAL HEALTH 209) ENDEAVOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ELECTRO SURGERY DEVICE