BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE LP 150

    MDR report key: 926912 · Received October 15, 2007

    Report

    Report Number
    3005350457-2007-00002
    Event Type
    Injury
    Date Received
    October 15, 2007
    Date of Event
    September 13, 2007
    Report Date
    October 11, 2007
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K070157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE FOR SUBGLOTTIC STENOSIS, THE PT DEVELOPED A PNEUMOTHORAX THAT WAS MOST LIKELY ANESTHESIA INDUCED. THE LASER FIBER WAS INTRODUCED THROUGH A HANDPIECE AND WAS PRESENT FOR APPROX 15 SECONDS PRIOR TO THE EVENT. THE LASER WAS NOT FIRED, AND THE FIBER WAS NOT USED TO TRANSMIT LASER ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE LP 150 CO2 WAVEGUIDE FIBER GEX OMNIGUIDE, INC. LP 150 LA070824AA-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention