BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MPX

    MDR report key: 7082703 · Received December 5, 2017

    Report

    Report Number
    1222993-2017-00047
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 5, 2017
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN EVALUATION OF THE ELITE MPX, ITS ALEXANDRITE 755NM WAVELENGTH LASER DELIVERED A HIGH ENERGY OUTPUT BEYOND THE +/-20% ACCEPTABLE SPECIFICATION RANGE. THE CYNOSURE TECHNICIAN PERFORMED CALIBRATION TESTS, BUT THE DEVICE CONTINUED TO DELIVER HIGH OUTPUT READINGS, OUTSIDE OF SPECIFICATION RANGE. SO THIS REQUIRED THE TECHNICIAN TO ADDRESS THE ISSUE BY INFORMING THE CUSTOMER TO STOP USAGE OF THE DEVICE UNTIL SYSTEM REPAIRS WERE COMPLETED. THE CYNOSURE TECHNICIAN INDICATED THAT THE CUSTOMER HAD THEIR ELITE MPX PREVIOUSLY SERVICED BY A THIRD PARTY COMPANY, SO IT IS POSSIBLE THE UNIT MAY NOT HAVE BEEN PROPERLY MAINTAINED/REPAIRED. THE EVENT ALSO INCLUDED A PATIENT IMPACT REGARDING A BURN ON THE LEG AREA FOLLOWING A LASER HAIR REMOVAL PROCEDURE. BURNS ARE TRANSIENT, EXPECTED SIDE EFFECTS FROM LASER TREATMENTS. THE PATIENT IN THIS EVENT HAS SINCE HEALED. THIS EVENT IS REPORTABLE BECAUSE THE DEVICE OPERATED OUT OF SPECIFICATION RANGE.

    Description of Event or Problem · 1

    THE DEVICE WAS FOUND OPERATING BEYOND SPECIFICATION RANGE, DELIVERING A VERY HIGH ENERGY OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864115 ELITE MPX ELITE MPX GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1