BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM S. P. A.

    MDR report key: 4349409 · Received December 9, 2014

    Report

    Report Number
    3004378299-2014-00107
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 5, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K123573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS DUE TO SPACER WRONG INSTALLATION (BY THE USER) AND IRREGULAR "SCANNER WRITING" SET-UP. AFTER THE REPAIR AND THE VERIFICATION PERFORMED BY TECH, THE LASER SYSTEM RESTARTED TO WORK PROPERLY. THE DEVICE IS NOT DIRECTLY SOLD IN THE US MARKET, BUT WE REPORTED THIS MALFUNCTION BECAUSE IT IS SIMILAR TO PRODUCTS WITH K123573 510(K) NUMBER.

    Description of Event or Problem · 1

    THE LASER SYSTEM HAS THE FOLLOWING PROBLEM: "SCANNER" MALFUNCTION. SKIN REDNESS, SIDE EFFECTS RECOVERED AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792685 QUANTA SYSTEM S. P. A. SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. YOULASER MT

    Patients

    Seq Age Sex Outcome Treatment
    1