BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 1163297 · Received September 9, 2008

    Report

    Report Number
    1717344-2008-00418
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 18, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 09/09/2008. TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATES THAT DURING PREPARATION FOR A RADIOFREQUENCY ABLATION, THE GENERATOR DISPLAYED HHH WHEN THE NEEDLE WAS CONNECTED TO IT, INDICATING VERY HIGH IMPEDANCE. A NEW NEEDLE, PAD AND PAD-EXTENSION CABLE WERE OPENED AND TRIED, BUT THIS DID NOT SOLVE THE PROBLEM. ANOTHER GENERATOR WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SYS 100V ENG RF ABLATION GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK