BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEGA JOULE LDD

    MDR report key: 17756359 · Received September 14, 2023

    Report

    Report Number
    MW5145686
    Event Type
    Other
    Date Received
    September 14, 2023
    Date of Event
    September 7, 2023
    Report Date
    September 12, 2023
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING CYSTOSCOPY WITH PHOTO SELECTIVE VAPORIZATION OF PROSTATE THE MEGA JOULE LLD SINGLE USE LASER PROBE STARTED TO MELT AT THE PLUG INTO THE THUL-60 THULIUM QUANTA CYBER TM 200 MACHINE SERIAL (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295131 MEGA JOULE LDD POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC MJLDD660 07423002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male