BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 1833934 · Received September 2, 2010

    Report

    Report Number
    1717344-2010-00604
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 5, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT GENERATOR HAS NOT BEEN RECEIVED FOR EVAL. IF THE GENERATOR 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 THE GENERATOR WAS UNABLE TO CONTINUE ABLATION SINCE IMPEDANCE WAS 500 OHMS AND OUTPUT WOULD NOT INCREASE OVER 20W. ALTHOUGH THE GENERATOR WAS REBOOTED, THE SAME SYMPTOM AS REPORTED OCCURRED AND THE GENERATOR KEPT MAKING ERROR SOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER GENERATOR. NO PT INJURY OCCURRED.

    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