BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAM PATH ROBOTIC FIBER

    MDR report key: 10527921 · Received September 11, 2020

    Report

    Report Number
    MW5096581
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 10, 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

    DURING SURGICAL PROCEDURE THE ROBOTIC FIBER STOPPED WORKING AND PRODUCED AN ODOR. NEW ONE OBTAINED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988780 BEAM PATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA191206AZ-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR