BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGITRON 4.0 DUAL RF/90 IEC 220-240V

    MDR report key: 7124512 · Received December 18, 2017

    Report

    Report Number
    2428235-2017-00002
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Report Date
    December 18, 2017
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K013255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE DEVICE, THERE WAS NO EVIDENCE OF A FIRE SEEN, BUT RATHER COMPONENTS WERE FOUND DAMAGED AND INCORRECTLY POSITIONED. A CONNECTOR WAS FOUND NOT PROPERLY ORIENTED/POSITIONED IN REVERSE WHICH WOULD THEN RESULT IN A POSSIBLE POLARITY SURGE ACROSS COMPONENTS ON THE MAIN PCB SYSTEM BOARD. THIS INCREASE IN VOLTAGE WOULD RESULT IN A POSSIBLE COMPONENT FAILURE/DAMAGE. THIS COMPONENT FAILURE DID NOT CAUSE THE OVERALL DEVICE TO COMBUST, RATHER WAS ISOLATED TO IMPACT ONLY THE MAIN SYSTEM BOARD. THE DEVICE WAS THEN REPAIRED WITH A REPLACEMENT PCB SYSTEM BOARD AND POWER SUPPLY. BASED ON THE LIMITED INFORMATION AVAILABLE, THIS EVENT IS REPORTABLE DUE TO A COMPONENT FAILURE ON THE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED OF AN INTERNAL DEVICE FIRE RESULTING IN BURNT COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905501 SURGITRON 4.0 DUAL RF/90 IEC 220-240V SURGITRON 4.0 DUAL RF/90 IEC 220-240V GEI CYNOSURE, INC. DBA ELLMAN

    Patients

    Seq Age Sex Outcome Treatment
    1