BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 24377477 · Received February 18, 2026

    Report

    Report Number
    MW5183996
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    February 11, 2026
    Report Date
    February 12, 2026
    Manufacturer
    QUANTA SYSTEM, S.P.A
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CYSTOSCOPY, LONG WOLF URETEROSCOPY, AND FLEXIBLE URETEROSCOPY WITH STENT REPLACEMENT AND SUPRA PUBIC CATHETER EXCHANGE WITH LASER LITHOTRIPSY WAS THE PROCEDURE. WHILE USING THE FLEXIBLE URETEROSCOPE WITH THE LASER INSIDE THE PATIENT THE LASER FIBER BROKE AND THE LASER BEAM BURNED THE END OF THE SCOPE. SURGEON REMOVED THE LASER FIBER AND FINISHED THE CASE, BUT THE SCOPE LENS WAS TURNING BLACK AND SPECKLED. DURING FRAGMENTATION THERE WAS A CHANGE IN THE FUNCTION OF THE LASER FIBER, AND I COULD TELL THAT THE LASER FIBER HAD BROKEN. AT THIS POINT PROVIDER PUT THE LASER ON STANDBY AND REMOVED THE FIBER AND A 3-INCH DISTAL AND WAS STILL WITHIN THE FLEXIBLE URETEROSCOPE. THIS WAS ALSO REMOVED AND COMPLETE REMOVAL OF THE LASER FIBER WAS CONFIRMED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 3/18/2026 FOR REPORT MW5183996 TO UPDATE THE MANUFACTURER AND PROCODE TO GEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122000 QUANTA SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX QUANTA SYSTEM, S.P.A A453560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male