BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICON

    MDR report key: 5100404 · Received September 24, 2015

    Report

    Report Number
    1222993-2015-00041
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    August 27, 2015
    Report Date
    September 24, 2015
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYNOSURE TECHNICIAN INSPECTED THE UNIT AND FOUND IT WAS OUT OF SPECIFICATION. THE ENERGY OUTPUT WAS 20% LESS THAN LASER'S NOMINAL ENERGY. LOW ENERGY WAS DUE TO REPAIRS NEEDED TO THE HANDPIECE. THE MACHINE ALSO DID NOT TRIGGER AN ERROR MESSAGE TO ALERT THE USER. THIS IS REPORTABLE 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
    632049 ICON ICON GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1