BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 5107272 · Received September 28, 2015

    Report

    Report Number
    5107272
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 11, 2015
    Manufacturer
    OMNIGUIDE, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LASER FIBER TESTED AT BEGINNING OF CASE AND NO LASER BEAM DETECTABLE. A FOUL ODOR WAS COMING FROM THE LASER. SALES REP CONTACTED AND WAS INSTRUCTED THAT LASER FIBER WAS "NO GOOD" AND TO REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639701 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL GEX OMNIGUIDE, INC BP-ROBOTIC LA15050503AC-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR