BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIGUIDE SURGICAL BEAMPATH ROBOTIC FIBER

    MDR report key: 10078447 · Received May 20, 2020

    Report

    Report Number
    MW5094617
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 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

    LASER FIBER STOPPED FIRING DURING SURGICAL PROCEDURE. SECOND LASER FIBER OBTAINED AND PROCEDURE CONTINUED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537394 OMNIGUIDE SURGICAL BEAMPATH ROBOTIC FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE INC. 191014BOP1

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR