BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 13009510 · Received December 15, 2021

    Report

    Report Number
    1717344-2021-01646
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    May 24, 2021
    Report Date
    December 15, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: CLINICAL EFFICACY OF SYSTEMIC CHEMOTHERAPY COMBINED WITH RADIOFREQUENCY ABLATION AND MICROWAVE ABLATION FOR LUNG CANCER: A COMPARATIVE STUDY SOURCE: INTERNATIONAL JOURNAL OF HYPERTHERMIA 2021, VOL. 38, NO. 1, 900¿906. HTTPS://DOI.ORG/10.1080/02656736.2021.1936214. 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 EXAMINED THE CLINICAL EFFICACY OF THERMAL ABLATION COMBINED WITH SYSTEMIC CHEMOTHERAPY IN THE TREATMENT OF PATIENTS WITH LUNG CANCER BETWEEN AUGUST 2017 AND DECEMBER 2019. IT IS NOTED THAT RADIOFREQUENCY ABLATION (RFA) WAS ACCOMPLISHED WITH EITHER COOLTIP RF ABLATION SYSTEM OR A COMPETITOR PRODUCT. THERE WERE 124 PARTICIPANTS AND COMPLICATIONS INCLUDED 2 CASES OF SKIN BURN AND 2 CASES OF WOUND INFECTION. TREATMENT AND OUTCOMES WERE UNKNOWN. TITLE: CLINICAL EFFICACY OF SYSTEMIC CHEMOTHERAPY COMBINED WITH RADIOFREQUENCY ABLATION AND MICROWAVE ABLATION FOR LUNG CANCER: A COMPARATIVE STUDY AUTHOR: FENG XU DATE OF PUBLICATION: 21-JUN-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905823 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female