BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEAMPATH ROBOTIC FIBER

    MDR report key: 11847760 · Received May 18, 2021

    Report

    Report Number
    MW5101396
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 13, 2021
    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

    TWO LASER FIBERS FROM THE SAME LOT NUMBER STOPPED WORKING DURING SURGICAL CASE. THIRD LASER FIBER WITH DIFFERENT LOT NUMBER OBTAINED AND WORKED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741689 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA210210AE-PI
    741690 BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. LA210210AE-PI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR