BEUDAMED
    FDA Adverse Event Summary report: N

    BEAMPATH ENT-L

    MDR report key: 2875273 · Received November 23, 2012

    Report

    Report Number
    2875273
    Date Received
    November 23, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHEN THE LASER WAS IN USE, THE LASER FIBER BLEW AND THEN DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BEAMPATH ENT-L POWERED LASER SURGICAL INSTRUMENT, LASER FIBER GEX OMNIGUIDE, INC. BEAMPATH ENT-L LA120727AB-P2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR