BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP SINGLE ELEC 20CM X 3CM KIT

    MDR report key: 2113033 · Received May 25, 2011

    Report

    Report Number
    1717344-2011-00404
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    May 2, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE INCIDENT 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 USE, THE PRODUCT WORKED NORMALLY DURING THE FIRST ABLATION BUT AFTER THE THIRD ABLATION, IT DID NOT COOL ANYMORE. THIS RESULTED IN AN EXTENSION OF OPERATING ROOM TIME OF MORE THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP SINGLE ELEC 20CM X 3CM KIT RF ABLATION ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 180283

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK