BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA LITHO 150 WATT HOLMIUM LASER

    MDR report key: 24680128 · Received March 24, 2026

    Report

    Report Number
    3016054554-2026-00001
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 23, 2026
    Manufacturer
    QUANTA SYSTEMS S.P.A.
    Product Code
    GEX
    UDI-DI
    08059173391738
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COMPLAINANT REPORTED THEY BELIEVE THE LASER WAS NOT FUNCTIONING PROPERLY AND PATIENT WAS READMITTED OVER THE WEEKEND FOR BLEEDING FOLLOWING HOLEP PROCEDURE. COMPLAINANT BELIEVES LASER MAY BE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312741 QUANTA LITHO 150 WATT HOLMIUM LASER HOLMIUM LASER GEX QUANTA SYSTEMS S.P.A. G58931 08059173391738

    Patients

    Seq Age Sex Outcome Treatment
    1