BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFA ELEC SINGLE 15 CM X 1 CM

    MDR report key: 5409943 · Received February 4, 2016

    Report

    Report Number
    1717344-2016-00110
    Event Type
    Malfunction
    Date Received
    February 4, 2016
    Date of Event
    November 19, 2015
    Report Date
    January 7, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(6) 2016. EVALUATION OF THE INCIDENT ELECTRODE FOUND VOIDS AND SCRATCHES IN THE INSULATION. THE AREA OF VOIDS FAILED HIGH VOLTAGE BREAKDOWN TESTING. ALTHOUGH THE EXACT CAUSE OF THE INSULATION DAMAGE CANNOT BE DETERMINED, SIMILAR DAMAGE HAS OCCURRED WITH THE USE OF GUIDING NEEDLES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN RF ABLATION PROCEDURE, THE PATIENT EXPERIENCED PAIN. THE COATING OF THE NEEDLE WAS FOUND DAMAGED. A NEW NEEDLE WAS USED AND THE CASE WAS COMPLETED. COVIDIEN'S INITIAL EVALUATION OF THE INCIDENT SAMPLE FOUND THE COATING ON THE NEEDLE WAS DAMAGED AND THE NEEDLE FAILED HIPOT TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67687 RFA ELEC SINGLE 15 CM X 1 CM ABLATION ELECTRODE NEY COVIDIEN LP RFA1510 42160014X

    Patients

    Seq Age Sex Outcome Treatment
    1