BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED LASER SURGICAL INSTRUMENT

    MDR report key: 25209542 · Received May 18, 2026

    Report

    Report Number
    MW5188390
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    November 10, 2025
    Report Date
    May 14, 2026
    Manufacturer
    LASER PERIPHERALS LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    "THE FIBER BROKE OFF WHILE BEING USED IN THE PATIENT'S LEFT URETER. THE PIECE HAD BROKEN OFF IN THE SCOPE." IT WAS REMOVED WITHOUT DIFFICULTY BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48942 POWERED LASER SURGICAL INSTRUMENT POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS LLC. 8000229 DA25042

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female