BEUDAMED
    FDA Adverse Event Death Summary report: N

    BEAMPATH 150

    MDR report key: 979532 · Received January 11, 2008

    Report

    Report Number
    3005350457-2008-00001
    Event Type
    Death
    Date Received
    January 11, 2008
    Date of Event
    December 14, 2007
    Report Date
    January 11, 2008
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K50541
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A TUMOR DEBULKING PROCEDURE IN THE LUNG USING THE LASER FIBER, THE PT EXPIRED. ALTHOUGH THE LASER FIBER WAS BEING USED AT THE TIME OF THE PT DEATH THERE WAS NO INDICATION THAT THE DEATH WAS A RESULT OF THE USE OF THE FIBER OR RELATED TO USE OF LASER ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAMPATH 150 LASER WAVEGUIDE FIBER GEX OMNIGUIDE, INC. BP 150 LA071004AI-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death