BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 13009515 · Received December 15, 2021

    Report

    Report Number
    3006451981-2021-00173
    Event Type
    Injury
    Date Received
    December 15, 2021
    Date of Event
    January 1, 2016
    Report Date
    December 15, 2021
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: RADIOFREQUENCY VERSUS MICROWAVE ABLATION FOR HEPATOCELLULAR CARCINOMA WITHIN THE MILAN CRITERIA IN CHALLENGING LOCATIONS: A RETROSPECTIVE CONTROLLED STUDY SOURCE: ABDOMINAL RADIOLOGY (2021) 46:3758¿3771 HTTPS://DOI.ORG/10.1007/S00261-021-03105-9. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED THE SAFETY AND EFFICACY OF RADIOFREQUENCY ABLATION (RFA) WITH MICROWAVE ABLATION (MWA) FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMA BETWEEN JANUARY 2016 AND DECEMBER 2016. IT IS NOTED THAT RFA WAS ACCOMPLISHED WITH EITHER COOLTIP RF ABLATION SYSTEM OR A COMPETITOR PRODUCT. THERE WERE 201 PARTICIPANTS AND COMPLICATIONS INCLUDED: PNEUMOTHORAX TREATED WITH CLOSED THORACIC DRAINAGE AND SUBCAPSULAR HEMORRHAGE WITH TREATMENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906056 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MEDICAL PRODUCTS UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other