BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP SINGLE ELEC 20CM X 3CM KIT

    MDR report key: 3043084 · Received March 13, 2013

    Report

    Report Number
    1717344-2013-00181
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 14, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVAL. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE FIRST ABLATION BY USE OF ACT2030, THEY REMOVED THE NEEDLE FROM THE PT AND FOUND A PART OF INSULATION COATING WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A NEW NEEDLE. THERE WAS NO PT INJURY. A METAL GUIDING NEEDLE WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106592 COOL-TIP SINGLE ELEC 20CM X 3CM KIT RF ABLATION ACCESSORY GEI COVIDIEN LP 239220X

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR ABLATION NEEDLE, CAT # ACT2020, LOT #238189X