BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 10355776 · Received July 31, 2020

    Report

    Report Number
    MW5095840
    Event Type
    Malfunction
    Date Received
    July 31, 2020
    Date of Event
    July 29, 2020
    Report Date
    July 30, 2020
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FIRST LASER FIBER PART MISSING THAT CONNECTS TO THE GENERATOR. THREE ADDITIONAL LASER FIBERS BURNED OUT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817504 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.
    817505 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.
    817506 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.
    817507 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR