BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE BEAMPATH NEURO-L FIBER

    MDR report key: 1662384 · Received April 15, 2010

    Report

    Report Number
    3005350457-2010-00001
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    March 1, 2010
    Report Date
    April 14, 2010
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K070157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CASE INVOLVED A YOUNG GIRL SUFFERING FROM AN INTRINSIC THORACIC (T1-T5) LIPOMA, A RARE FORM OF PEDIATRIC LIPOMA. DURING THE CASE, THE CO2 LASER FIBER WAS USED TO RESECT THE FATTY TISSUE. INTRA-OPERATIVE NERVE MONITORING WAS UNEVENTFUL AND IN THE IMMEDIATE POST-OPERATIVE PERIOD, (B) (6) REPORTS THAT THE GIRL WAS "MOVING BOTH LEGS WELL". HOWEVER, OVER THE NEXT 2-4 DAYS, THE PT DEVELOPED UNILATERAL LEG WEAKNESS WITH POOR PROPRIOCEPTION. MRI WAS PERFORMED, BUT DID NOT DEMONSTRATE SPINAL CORD COMPRESSION. ON POST-OPERATIVE DAY (POD) 6, MOTOR FUNCTION WAS ABSENT. OVER THE NEXT 4 DAYS, SHE BEGAN TO REGAIN STRENGTH (BASED ON SURGEON'S CORRESPONDENCE, UPDATED UP UNIT POD 10). (B) (6) INDICATES THAT HE IS CERTAIN THAT THIS (TRANSIENT) DISTURBANCE IN MOTOR FUNCTION WAS A DIRECT RESULT OF CO2 LASER RELATED THERMAL INJURY. (B) (6) IS A PEDIATRIC NEUROSURGEON WHO HAS USED LASERS IN THE PAST, INCLUDING OUR SYSTEM. THE SURGEON DISMISSES ANY FORM OF SPINAL CORD MANIPULATION OR COMPRESSION THAT COULD POTENTIALLY RESULT IN SUCH OUTCOMES. SIMILARLY, HE ARGUES AGAINST VASCULAR CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE BEAMPATH NEURO-L FIBER CO2 WAVEGUIDE FIBER GEX OMNIGUIDE, INC. NEURO-L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Hospitalization