BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFLEX 273 LASER LITHOTRIPSY FIBER

    MDR report key: 24547919 · Received March 9, 2026

    Report

    Report Number
    MW5184920
    Event Type
    Injury
    Date Received
    March 9, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 28, 2026
    Manufacturer
    INNOVAQUARTZ LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING SHOCKWAVE LITHOTRIPSY AND CYSTOSCOPY CASE, SURGEON WAS PLACING A LASER FIBER IN URETER UNDER VISUALIZATION OF CYSTOSCOPE IN USED TO BREAK UP KIDNEY STONES. THE TIP OF LASER FIBER BROKE OFF, AS IT WAS HIT BY SHOCKWAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342372 PROFLEX 273 LASER LITHOTRIPSY FIBER POWERED LASER SURGICAL INSTRUMENT GEX INNOVAQUARTZ LLC 22425001

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female