BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE LASER

    MDR report key: 4940052 · Received July 24, 2015

    Report

    Report Number
    1222993-2015-00031
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 24, 2015
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K034030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYNOSURE TECHNICIAN INSPECTED THE UNIT AND FOUND THE UNIT WAS OUT OF SPECIFICATION. THE ENERGY OUTPUT WAS 20% LESS THAN LASER'S NOMINAL ENERGY. THE LOW ENERGY WAS DUE TO REPAIRS NEEDED FOR THE DEVICE'S LENSES/MIRRORS AND HANDPIECE. THE MACHINE ALSO DID NOT TRIGGER AN ERROR MESSAGE TO ALERT THE USER. THIS IS REPORTABABLE BECAUSE THE CUSTOMER'S LASER WAS OPERATING OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    THE LASER DEVICE WAS FOUND OPERATING OUT OF SPECIFICATION DURING THE SERVICE EVALUATION AND DID NOT TRIGGER AN ERROR MESSAGE TO ALERT THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484337 ELITE LASER ELITE LASER GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR