BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGA JOULE FIBER SIDE FIRE FIBER

    MDR report key: 16443153 · Received February 24, 2023

    Report

    Report Number
    MW5115185
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    February 21, 2023
    Report Date
    February 21, 2023
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A CYSTOSCOPY WITH PHOTOVAPORIZATION OF THE PROSTATE. DURING THE PROCEDURE, THE MEGA JOULE FIBER BROKE AND A NEW ONE WAS PROVIDED TO THE PHYSICIAN. THIS MEGA JOULE FIBER BROKE AS WELL AND THE PHYSICIAN HAD TO USE A DIFFERENT KIND OF LASER PROBE TO COMPLETE THE PROCEDURE. REFERENCE REPORT: MW5115184.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844560 MEGA JOULE FIBER SIDE FIRE FIBER POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC 200W 35352002

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male