BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA SYSTEM PERFORMANCE FIBER 272 UM

    MDR report key: 21850582 · Received April 16, 2025

    Report

    Report Number
    MW5169133
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 10, 2025
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PROCEDURE: CYSTOSCOPY WITH LEFT URETEROSCOPY AND LASER LITHOTRIPSY WITH STENT PLACEMENT. SURGEON ADVANCED A 200 MICRON LASER FIBER THROUGH THE FLEXIBLE URETEROSCOPE AND A MID-POLE STONE WAS FRAGMENTED WITHOUT ISSUE. PATIENT ALSO HAD A LOWER-POLE STONE. DUE TO STEEP ANGULATION, A PART OF THE STONE WAS ABLE TO BE LASERED; HOWEVER, THE TORQUE ON THE URETEROSCOPE WAS SEVERE ENOUGH TO FRACTURE THE LASER FIBER WITHIN THE SCOPE. ATTEMPTS TO REMOVE EVERYTHING INTACT WERE UNSUCCESSFUL AND THE DISTAL FIBER REMAINED IN SITU. AFTER SEVERAL ATTEMPTS, THE DISTAL TIP WAS GRASPED WITH A DAKOTA BASKET AND IT WAS REMOVED INTACT. NO COMPLICATIONS OR INJURY TO PATIENT. A 75 Y/O WITH LEFT PELVIC KIDNEY WITH LARGE 6 CM CYST CAUSING MEDIAL DISPLACEMENT AND AN 11MM LOWER POLE STONE AS WELL AS ADDITIONAL FRAGMENTS IN THE MID-POLE. PATIENT HAD PRIOR STONE EPISODES. 'FOR TEC,' (B)(6) US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133364 QUANTA SYSTEM PERFORMANCE FIBER 272 UM POWERED LASER SURGICAL INSTRUMENT GEX QUANTA SYSTEM, S.P.A. A444267

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention