BEUDAMED
    FDA Adverse Event Summary report: N

    COOL-TIP RF SYS 100V ENG

    MDR report key: 2240572 · Received August 23, 2011

    Report

    Report Number
    1717344-2011-00722
    Date Received
    August 23, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 25, 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 INCIDENT GENERATOR 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 PREPARATION FOR AN ABLATION PROCEDURE WHILE THE PT WAS PRESENT, THERE WAS A PROBLEM WITH THE TEMPERATURE DISPLAY. ANOTHER GENERATOR WAS USED FOR THE PROCEDURE. 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