BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGITRON FFPF EMC

    MDR report key: 4821949 · Received June 5, 2015

    Report

    Report Number
    2428235-2015-00003
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 4, 2015
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K972072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CANINE UNDERWENT RIGHT FOREQUARTER AMPUTATION WITH THE EMC ELECTROSURGICAL GENERATOR AND THE NEUTRAL PAD WAS PLACED ON THE DOG'S BACK WITH A SMALL PORTION (APPROXIMATELY 2 INCH TRIANGLE) CONTACTING SHAVED SKIN WHILE THE REMAINDER CONTACTED FUR. THE BURN WAS LOCATED IN THE SHAVED AREA WHERE THE NEUTRAL PAD CONTACTED THE SKIN DIRECTLY, WAS MINOR IN NATURE AND DID NOT REQUIRE SUBSEQUENT INTERVENTIONS OR TREATMENT. THE NEUTRAL PAD WAS MISAPPLIED TO THE PATIENT (DOG) BY BEING PLACED OVER BOTH SHAVED AND FUR COVERED AREAS. THE DIFFERENCE IN IMPEDANCE OVER THE PAD CAUSED A CONCENTRATION OF ENERGY IN THE LOW IMPEDANCE AREA AND CAUSED A BURN. ALTHOUGH THIS EMC WAS BEING USED FOR VETERINARY APPLICATIONS, THE PRODUCT IS ALSO AVAILABLE FOR HUMAN APPLICATIONS. THE LIKELIHOOD OF A SIMILAR EVENT OCCURING IN A HUMAN IS LOW AS THERE IS LESS OPPORTUNITY FOR THE DRASTIC DIFFERENCE IN IMPEDANCES AS THAT BETWEEN FUR AND SKIN IN VETERINARY APPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365037 SURGITRON FFPF EMC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CYNOSURE, INC. DBA ELLMAN IEC-NPC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention