BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE

    MDR report key: 19940950 · Received August 7, 2024

    Report

    Report Number
    MW5158177
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 2, 2024
    Manufacturer
    LASER ENGINEERING, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CO2 LASER TIP BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636144 ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE POWERED LASER SURGICAL INSTRUMENT GEX LASER ENGINEERING, INC. HWG300-2.0-3.0 51242753

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female