BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RFA-E-GENERATOR

    MDR report key: 1890755 · Received November 1, 2010

    Report

    Report Number
    1717344-2010-00740
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT GENERATOR HAS BEEN REQUESTED BUT TO DATE, HAS NOT BEEN REC'D FOR EVAL. IF THE GENERATOR 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 CUSTOMER REPORTED THAT DURING A PERCUTANEOUS PROCEDURE USING THE E-SERIES SYSTEM AND THREE ELECTRODES, AFTER APPROX 10 MINS OF ABLATION THE SYSTEM STOPPED. THE MAINS POWER CABLE, CONNECTIONS, AND MAINS POWER SWITCH WERE CHECKED BUT THE SYSTEM WAS NOT ABLE TO BE POWERED BACK UP. AS THE PROCEDURE HAD NOT BEEN COMPLETED, THE PHYSICIAN OPTED TO UTILIZE ANOTHER SYSTEM TO FINISH THE PROCEDURE. THE ABLATION WAS COMPLETED W/O ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RFA-E-GENERATOR RF ABLATION GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK