BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP SINGLE ELEC 15CM X 3CM KIT

    MDR report key: 3221667 · Received July 1, 2013

    Report

    Report Number
    1717344-2013-00482
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE#: (B)(4). DATE OF INITIAL REPORT: (B)(4) 2013. 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 INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY EXPERIENCED PROBLEMS WITH UNSTABLE TEMPERATURES DURING AN ABLATION PROCEDURE. THE PROCEDURE TIME WAS EXTENDED BY MORE THAN 30 MINUTES AND THE PT REQUIRED REINTUBATION. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298207 COOL-TIP SINGLE ELEC 15CM X 3CM KIT ABLATION ACCESSORY GEI COVIDIEN LP 242212X

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR