BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE+

    MDR report key: 19766836 · Received July 17, 2024

    Report

    Report Number
    1222993-2024-00038
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Report Date
    August 15, 2024
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K141425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION IS NOT YET COMPLETED. ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP ASSESSMENT WILL BE SUBMITTED. BURNS ARE EXPECTED SIDE EFFECTS FROM SUCH TREATMENTS; HOWEVER THIS EVENT IS REPORTABLE BECAUSE IT IS AN ACCIDENTAL RADIATION OCCURRENCE (ARO) SINCE SITE REPORTED AN UNINTENDED DISCHARGE OF LASER ENERGY.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT TO MEDWATCH 1222993-2024-00038 DUE TO DEVICE EVALUATION COMPLETED. THE HANDPIECE ALLEGEDLY FIRED BECAUSE THE WIRE THAT CONNECTS TO THE HANDPIECE WAS BROKEN. CYNOSURE FIELD SERVICE ENGINEER (FSE) CONFIRMS NO FALSE TRIGGERING OCCURRED. TO RESOLVE THE BROKEN WIRE, CYNOSURE FSE SOLDERED THE WIRE BACK IN PLACE. SOFTWARE WOULD NOT BE ABLE TO DETERMINE IF TRIGGER WAS PRESSED OR IF IT WAS SHORTED. THE DEVICE DID NOT FAIL TO DETECT SINCE THE ISSUE IS RELATED TO THE ELECTRICAL CABLE OF THE HANDPIECE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ELITE+ PULSED ON ITS OWN AND BURNED THE OPERATOR'S HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366350 ELITE+ ELITE+ GEX CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown