BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CO2 HANDPIECE DELIVERY SYSTEM

    MDR report key: 7880685 · Received September 14, 2018

    Report

    Report Number
    MW5079833
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 13, 2018
    Manufacturer
    LASER ENGINEERING, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CO2 LASER ATTACHMENT HANDPIECE IS NOT MARKED WITH ANY PRODUCT IDENTIFIERS AND THIS MAKES IT NEAR IMPOSSIBLE TO TRACK THE IFU. THE COMPANY HAS PROVIDED MULTIPLE IFU'S SURROUNDING DEVICE STERILIZATION AND WITHOUT A PRODUCT ID ON THE MEDICAL INSTRUMENT, IT'S VERY HARD TO VERIFY STERILIZATION PARAMETERS OR TRUE PRODUCT IDENTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716735 CO2 HANDPIECE DELIVERY SYSTEM CO2 LASER ATTACHMENT GEX LASER ENGINEERING, INC. 125MM HANDPIECE

    Patients

    Seq Age Sex Outcome Treatment
    1