BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE BEAMPATH NEURO-L

    MDR report key: 1439457 · Received August 12, 2009

    Report

    Report Number
    3005350457-2009-00001
    Event Type
    Injury
    Date Received
    August 12, 2009
    Date of Event
    May 18, 2009
    Report Date
    July 14, 2009
    Manufacturer
    OMNIGUIDE, INC
    Product Code
    GEX
    PMA / PMN Number
    K070157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SURGERY TO REMOVE AN OLFACTORY GROOVE MENINGIOMA. THE OMNIGUIDE BEAM PATCH WAVE GUIDE WAS USED TO DISSECT THE SKULL BASE TUMOR DURING THE OPEN CRANIOTOMY PROCEDURE. ONE DAY POST OPERATIVELY, PNEUMOCEPHALUS WAS IDENTIFIED ANTERIOR TO THE FRONTAL LOBE DURING CT SCAN. THE PATIENT WAS TREATED WITH 100% OXYGEN TO REMOVE THE EXCESS AIR. ON DAY 2, THE PATIENT'S CT SCAN INDICATED INCREMENTAL GROWTH IN THE AIR POCKET DESCRIBED ABOVE. A CSF LEAK WAS DETECTED AT THIS TIME, UPON PHYSICAL EXAMINATION OF THE PATIENT. ON DAY 3, IMAGING REVEALED ADDITIONAL GROWTH IN THE AIR POCKET AND THE PATIENT UNDERWENT 2ND LOOK SURGERY TO REPAIR THE DURAL DEFECT AND CSF LEAK. THIS SURGERY DID NOT REPAIR THE DEFECT, A 3RD RE-OPERATION WAS PERFORMED TO REPAIR SITE OF LEAK, THUS RESOLVING PATIENT'S SYMPTOMS. THERE WAS NO INDICATION THAT THE FIBER MALFUNCTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other