BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 11998859 · Received June 14, 2021

    Report

    Report Number
    MW5101873
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 10, 2021
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TRIED TO FIRE THE LASER AND IT WOULDN'T FIRE, AND WE COULD SMELL THE SMELL WHEN IT BURNS OUT. WE REMOVED DEFECTIVE FIBER FROM THE STERILE FIELD AND REPLACED IT WITH A NEW FIBER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886411 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.
    886414 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA210209BP-P1
    886415 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR