BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 2961036 · Received January 16, 2013

    Report

    Report Number
    1717344-2013-00025
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 18, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVALUATION. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ALARM SOUND WAS HEARD DURING AN RF ABLATION PROCEDURE AND THE GENERATOR STOPPED WORKING. THE POWER WAS SWITCHED ON AND OFF MULTIPLE TIMES BUT THE PROBLEM CONTINUED. THE PROCEDURE WAS STOPPED WITHOUT ANY HARM TO THE PT. AN ADD'L OPERATION IS PLANNED FOR A FUTURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23752 COOL-TIP RF SYS 100V ENG RF ABLATION GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR