BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRALASE FLEXIBLE LASER WAVEGUIDE

    MDR report key: 15824513 · Received November 18, 2022

    Report

    Report Number
    15824513
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    August 16, 2022
    Report Date
    November 14, 2022
    Manufacturer
    LASER ENGINEERING
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CO2 LASER FIBER WAS NOT COUPLING WITH THE LASER MACHINE. IT KEPT POPPING OFF. BIOMED STAFF WAS CALLED, AND THEY TRIED A FEW DIFFERENT CO2 LASER FIBERS THAT DID NOT WORK. THEY WERE ALL THE SAME LOT NUMBER. ALL THE FIBERS WERE PULLED OFF THE SHELVES. UPON INSPECTION THE CO2 LASER FIBER WAS DISCONNECTING FROM THE HUB THAT SCREWS INTO THE LASER CONSOLE WHEN GOING TO USE IT. MANUFACTURER RESPONSE FOR POWERED LASER SURGICAL INSTRUMENT, ULTRALASE FLEXIBLE LASER WAVEGUIDE (PER SITE REPORTER) THE REP PICKED THESE FIBERS UP THREE MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322148 ULTRALASE FLEXIBLE LASER WAVEGUIDE POWERED LASER SURGICAL INSTRUMENT GEX LASER ENGINEERING HWG300-OTO 51242757

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA Female