BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE ENT ELITE FIBER

    MDR report key: 10835737 · Received November 13, 2020

    Report

    Report Number
    10835737
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 22, 2020
    Report Date
    October 30, 2020
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE LASER, HAD TO SWITCH OUT HELIUM TANK, AFTERWARDS THE FIBER WAS NO LONGER WORKING. ATTACHED THE TRIAL FIBER WHICH WORKED, HAD TO OPEN NEW FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300840 ELEVATE ENT ELITE FIBER POWERED LASER SURGICAL INSTRUMENT GEX OMNIGUIDE, INC. 322001 LA200219AO-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 5110 DA