BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFLEX¿

    MDR report key: 24828606 · Received April 9, 2026

    Report

    Report Number
    24828606
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    April 5, 2026
    Report Date
    April 6, 2026
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    UDI-DI
    00816959020521
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A UROLOGY SURGICAL PROCEDURE USING A LASER FIBER AND MACHINE SUPPLIED BY ROCKY TOP LITHO, A LASER WIRE BURST IN THE PROVIDER'S HANDS AND HAD TO BE REMOVED FROM THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557451 PROFLEX¿ POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC SINGLE USE 200 LASER LITHOTRIPSY FIBER 25125002 00816959020521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other