BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILITY

    MDR report key: 18993388 · Received March 27, 2024

    Report

    Report Number
    MW5153313
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    November 8, 2023
    Report Date
    March 25, 2024
    Manufacturer
    LASER PERIPHERALS LLC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    FIBER BROKE DURING LASER LITHOTRIPSY WITH HOLMIUM LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2048012 AGILITY POWERED LASER SURGICAL INSTRUMENT GEX LASER PERIPHERALS LLC. 8000230 DC22036

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male