BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 2230919 · Received July 20, 2011

    Report

    Report Number
    1717344-2011-00576
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 24, 2011
    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 GENERATOR HAS NOT BEEN RECEIVED FOR EVALUATION. 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 THAT DURING THE RF ABLATION PROCEDURE WHEN THE ACCESSORY WAS CONNECTED TO THE GENERATOR, ERROR CODE LL WAS DISPLAYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

    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