BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8000229

    MDR report key: 22738814 · Received August 7, 2025

    Report

    Report Number
    22738814
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    March 10, 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 DOING A URETEROSCOPY LASER LITHOTRIPSY WITH THE AGILITI HOLMIUM LASER THE 272UM LASER FIBER STOPPED WORKING AND APPEARED BROKE OR FRAYED X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940897 8000229 POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS, LLC 8000229 DA25012

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male