BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF CLUSTER 20 CM

    MDR report key: 1012787 · Received March 12, 2008

    Report

    Report Number
    1717344-2008-00082
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 15, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE WAS NOT RETURNED FOR EVAL. THEREFORE, AN EVAL COULD NOT BE PERFORMED. VALLEYLAB LABELING REGARDING THE SETUP OF THE COOL-TIP SYSTEM INCLUDES THE USE OF STERILE WATER WHICH PREVENTS UNINTENDED CONTAMINATION OF THE STERILE FIELD. CONTINUOUS IMPROVEMENT TO TUBING SET DESIGN HAVE SIGNIFICANTLY REDUCED THE TREND IN LEAKAGE COMPLAINTS.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE, A WATER LEAKAGE OCCURRED IN THE CONNECTOR OF NEEDLE ELECTRODE KNOB AND TUBING. STERILE WATER WAS IN USE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF CLUSTER 20 CM ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 110488

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK