BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PROFLEX 200 LASER FIBER

    MDR report key: 23019483 · Received September 10, 2025

    Report

    Report Number
    MW5175900
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 8, 2025
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SCHEDULED LASER LITHOTRIPSY PROCEDURE USING A DIGITAL URETEROSCOPE AND BARD PROFLEX 200 LASER FIBER (REF: LSU200PF, LOT #: 09125005, EXP: 04-16-2028), A POPPING NOISE WAS HEARD WHILE THE LASER WAS ENGAGED. DR. REMOVED THE LASER FIBER AND FOUND IT BROKEN. FURTHER INSPECTION REVEALED THE LASER HAD BURNED A HOLE THROUGH THE DISPOSABLE DIGITAL URETEROSCOPE. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2706864 BARD PROFLEX 200 LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX C.R. BARD, INC. 09125005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other