BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000229

    MDR report key: 22738816 · Received August 7, 2025

    Report

    Report Number
    22738816
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    March 24, 2025
    Report Date
    March 26, 2025
    Manufacturer
    LASER PERIPHERALS, LLC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHILE PERFORMING A URETEROSCOPY WITH HOLMIUM LASER THE AGILITI LASER FIBER STOPPED WORKING (BROKE). ANOTHER FIBER WAS OPENED AND THE CASE COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940899 8000229 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000229 DA25012

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male