BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 5055885 · Received September 4, 2015

    Report

    Report Number
    5055885
    Event Type
    Malfunction
    Date Received
    September 4, 2015
    Date of Event
    July 20, 2015
    Report Date
    August 13, 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

    WHEN LASER FIBER WAS PLUGGED IN, ERROR MESSAGE STATING LASER FIBER WAS NOT CONNECTED AND WRONG LASER FIBER ATTACHED WAS DISPLAYED ON SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589048 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. LA150209ADP1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR