BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED

    MDR report key: 1240849 · Received November 12, 2008

    Report

    Report Number
    1720159-2008-00033
    Event Type
    Other
    Date Received
    November 12, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 15, 2008
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE EVENT DESCRIPTION, THE REPORTED MALFUNCTION WAS USER RELATED ERROR AND NOT A DEVICE FAILURE. ACCORDING TO THE EVENT DESCRIPTION, THE ASSISTANT BECAME PART OF THE CIRCUIT BY TOUCHING THE VESSEL WHILE THE SURGEON WAS APPLYING THE ELECTROSURGICAL ENERGY. TOUCHING THE PT, WHICH IS AN EARTH GROUND, MAY BECOME THE PREFERENTIAL CURRENT PATH AND THUS PRODUCE BURNS (RF LEAKAGE BURNS).

    Description of Event or Problem · 1

    SURGEON WAS USING CONMED PENCIL, ASSISTANT WAS HOLDING HEMOSTATS ON VESSEL. WHILE VESSEL WAS BEING CAUTERIZED, ASSISTANT WAS SHOCKED. ASSISTANT RECEIVED A SMALL BLACK SPOT ON FINGER AFTER INCIDENT. ASSISTANT STATED HE DID NOT HAVE A HOLE IN HIS GLOVE. THE ASSISTANT CUT THE CORD OF PENCIL AFTER USE AND DISPOSED OF PRODUCT. LOT NUMBER WAS NOT RECORDED BY USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ELECTROSURGICAL PENCIL GEI CONMED ELECTROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other