BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9826382 · Received March 12, 2020

    Report

    Report Number
    1717344-2020-00287
    Event Type
    Death
    Date Received
    March 12, 2020
    Date of Event
    February 17, 2017
    Report Date
    March 12, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE RADIOFREQUENCY ABLATION USING A 10-MM TARGET MARGIN FOR SMALL HEPATOCELLULAR CARCINOMA IN PATIENTS WITH LIVER CIRRHOSIS: A PROSPECTIVE RANDOMIZED TRIAL SOURCE J SURG ONCOL., VOLUME 115, 2017(971¿979) ARTICLE NUMBER: 8 DATE OF PUBLICATION: 17 FEB 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY PERFORMED ON BETWEEN OCTOBER 2010 AND JUNE 2012, ON A STUDY TO COMPARE 3-YEAR CLINICAL OUTCOMES OF RADIOFREQUENCY ABLATION (RFA) TARGETING 5- OR 10-MM MARGINS FOR SMALL HEPATOCELLULAR CARCINOMAS (HCCS) IN CIRRHOTIC PATIENTS. OUT OF 96 PATIENTS 32 DIED. IT IS UNKNOWN AT THIS TIME IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288647 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death