BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTA SYSTEM

    MDR report key: 4002181 · Received August 6, 2014

    Report

    Report Number
    3004378299-2014-00066
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Product Code
    GEX
    PMA / PMN Number
    K100558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO CONFIRM THE INTERMITTENT RESTART OF THE DEVICE. THE DEVICE WAS CHECKED AND IT WAS FOUND IN COMPLIANCE WITH THE SPECIFICATION AND IT WAS NOT POSSIBLE TO REPLICATE THE FAILURE AFTER A LONG RUN. THE DEVICE WAS RETURNED TO THE END USER. WE ARE UNAWARE ABOUT PATIENT INJURY.

    Description of Event or Problem · 1

    THE END USER IS CLAIMING THAT THE LASER SYSTEM IS RESTARTING ITSELF AFTER 1 MINUTE OF USE. UNABLE TO REPLICATE THE PROBLEM. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461573 QUANTA SYSTEM SURGICAL LASER GEX QUANTA SYSTEM, S.P.A. IG 1470

    Patients

    Seq Age Sex Outcome Treatment
    1