BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPERIUM CO2 LASER FIBER

    MDR report key: 10211633 · Received June 30, 2020

    Report

    Report Number
    10211633
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    July 12, 2019
    Report Date
    July 23, 2019
    Manufacturer
    LASER ENGINEERING, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CO2 LASER TIP BROKE INSIDE PATIENT BODY. TIP WAS RETRIEVED BY SUR. EXP 03-26-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675845 IMPERIUM CO2 LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX LASER ENGINEERING, INC. CO2-500 31966060

    Patients

    Seq Age Sex Outcome Treatment
    1 12775 DA