BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 10179770 · Received June 19, 2020

    Report

    Report Number
    MW5095130
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 18, 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

    PATIENT UNDERGOING SURGICAL PROCEDURE WHEN THE LASER FIBER STOPPED WORKING AND STAFF NOTED A STRONG ODOR. SECOND LASER FIBER OBTAINED AND WORKED FOR 2 MINUTES THEN STOPPED. STRONG ODOR SMELLED AGAIN. THIRD LASER FIBER OBTAINED AND FUNCTIONED UNTIL END OF CASE. FDA SAFETY REPORT ID #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637817 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. LA191007
    637818 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. LA191014B0PI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR