BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTA LITHO 150 WATT HOLMIUM LASER

    MDR report key: 24680244 · Received March 24, 2026

    Report

    Report Number
    3016054554-2026-00002
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    March 4, 2026
    Report Date
    March 5, 2026
    Manufacturer
    QUANTA SYSTEMS S.P.A.
    Product Code
    GEX
    UDI-DI
    08059173391738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    COMPLAINANT REPORTED THEY BELIEVE LASER WAS NOT FUNCTIONING PROPERLY AND DETERMINED TO PULL IT OUT OF SERVICE UNTIL A TECHNICIAN COULD LOOK AT IT. COMPLAINANT REPORTED THEY BELIEVE THE LASER CAUSED EXCESSIVE BLEEDING DURING 2 HOLEPS. ATTENDEE BELIEVED IT WAS RELATED TO A FW UPDATED WHICH HAD BEEN DONE THE DAY PRIOR. PROCEDURE WAS COMPLETED AS BIPOLAR WAS USED TO CONTROL BLEEDING. PATIENT WAS ADMITTED OVERNIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29925 QUANTA LITHO 150 WATT HOLMIUM LASER HOLMIUM LASER GEX QUANTA SYSTEMS S.P.A. G58931 08059173391738

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization