BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1728725 · Received June 16, 2010

    Report

    Report Number
    3005350457-2010-00002
    Event Type
    Injury
    Date Received
    June 16, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 12, 2010
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K093451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DR (B) (6) OF (B) (6) HOSPITAL IN (B) (6) PERFORMED A STAPEDECTOMY ON A MALE PT. WHILE USING THE OMNIGUIDE LASER FIBER, THE SURGEON HAD THE GAS SETTING TOO HIGH AND AS A RESULT, BLEW PERILYMPH FLUID OUT OF THE INNER EAR. HE ALSO NOTICED SOME CHARRING ON THE INNER EAR FROM THE LASER SHOTS. THE PT WOKE UP WITH SOME DIZZINESS BUT DID HAVE HEARING (PRIOR TO THE PROCEDURE, THE PT WOULD HAVE HAD NO HEARING). TWO WEEKS AFTER THE PROCEDURE, THE PT REPORTS SOME DIZZINESS BUT IT WAS DIMINISHING. THE SURGEON STATED THAT THE PROGNOSIS IS GOOD. THE HOSPITAL WAS NOT ABLE TO PROVIDE OMNIGUIDE WITH SPECIFIC PRODUCT MODEL OR LOT NUMBER INFO. THEY DID NOT REPORT THAT THE PRODUCT MALFUNCTIONED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CO2 WAVEGUIDE FIBER GEX OMNIGUIDE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other