BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL-TIP RF SYS 117V ENG

    MDR report key: 1693933 · Received May 12, 2010

    Report

    Report Number
    1717344-2010-00333
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 24, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE INCIDENT GENERATOR WAS RETURNED TO TYCO HEALTHCARE SINGAPORE SERVICE CENTER FOR EVALUATION. EVALUATION IDENTIFIED A RANDOM COMPONENT FAILURE OF A CAPACITOR ON THE POWER SUPPLY BOARD. ADDITIONALLY, THE VOLTAGE FROM THE TOROID WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LIVER RF ABLATION TREATMENT, THE GENERATOR POWER STOPPED AND A BURNING SMELL WAS RELEASED INTO THE AIR. AFTER CHECKING, THE SMELL WAS FOUND TO BE COMING FROM THE BACK SIDE OF RF GENERATOR. THE GENERATOR WAS UNABLE TO RE-START. THE DOCTOR STOPPED THE PROCEDURE AND WAITED FOR A BACK-UP GENERATOR BEFORE PROCEEDING. THE PT WAS EXPOSED TO FIVE HOURS OF GENERAL ANESTHESIA, WHICH MAY HAVE HAD SOME EFFECT ON RENAL/LIVER FUNCTION. THE PT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SYS 117V ENG RF ABLATION GENERATOR GEI COVIDIEN LP (VALLEYLAB)

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other (B) (4)| CTSW SWITCHING CONTROLLER,