BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE BP 100 CO2 LASER FIBER

    MDR report key: 865986 · Received June 14, 2007

    Report

    Report Number
    3005350457-2007-00001
    Event Type
    Injury
    Date Received
    June 14, 2007
    Date of Event
    May 15, 2007
    Report Date
    June 14, 2007
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING TREATED FOR LARYNGEAL AND TRACHEAL PAPILLOMAS. THE PHYSICIAN VENTILATED USING A CLOSED VENTILATION SYSTEM. THE PAPILLOMA TISSUE SEALED AROUND THE BRONCHOSCOPE SEALING THE AIRWAY AND CAUSING A PNEUMOTHORAX. THE PATIENT HAD A CHEST TUBE INSERTED. PATIENT IS DOING WELL. THE LASER FIBER WAS USED OR 10-15 SECONDS DURING THE SURGERY. GAS FLOW FROM THE FIBER IS BETWEEN 2-3 LETTERS PER MINUTE. THE DEVICE PERFORMED AS DESIGNED AND THERE IS NO INDICATION THAT THE EVENT WOULD NOT OCCURED IF THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE BP 100 CO2 LASER FIBER LASER FIBER GEX OMNIGUIDE, INC. BP 100 LA070307AB-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention