BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MPX

    MDR report key: 4152321 · Received October 3, 2014

    Report

    Report Number
    1222993-2014-00032
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    October 1, 2014
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS PERFORMED ON THE LASER AND THE CYNOSURE SERVICE TECHNICIAN WAS NOT ABLE TO DUPLICATE THE PROBLEM. THE SERVICE TECHNICIAN REPLACED THE TRIGGER ON THE HANDPIECE AND THE HANDPIECE FUNCTIONED TO SPECIFICATION AFTER THE REPAIR. FURTHER INVESTIGATION IS BEING CONDUCTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE LASER CONTINUED TO FIRE ON ITS OWN DURING A TREATMENT. THE LASER WAS NOT DIRECTED AT THE PATIENT AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617223 ELITE MPX ELITE MPX GEX

    Patients

    Seq Age Sex Outcome Treatment
    1