BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9783260 · Received March 3, 2020

    Report

    Report Number
    1717344-2020-00231
    Event Type
    Injury
    Date Received
    March 3, 2020
    Date of Event
    March 24, 2015
    Report Date
    March 3, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE UNRESECTABLE ADRENAL METASTASES: CLINICAL OUTCOMES OF RADIOFREQUENCY ABLATION1 SOURCE RADIOLOGY.RSNA.ORG, VOLUME 277, 2015 (584-593) ARTICLE NUMBER: 2 DATE OF PUBLICATION: 24 MARCH 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY, ITS PURPOSE WAS TO RETROSPECTIVELY EVALUATE THE CLINICAL OUTCOMES OF RADIOFREQUENCY (RF) ABLATION FOR THE TREATMENT OF UNRESECTABLE ADRENAL METASTASIS. FROM FEBRUARY 2005 THROUGH MAY 2014, 35 PATIENTS (25 MEN AND 10 WOMEN; MEAN AGE, 64.7 YEARS 6 9.6; AGE RANGE, 39¿82 YEARS) UNDERWENT RF ABLATION TO TREAT 41 METASTATIC ADRENAL TUMORS FROM LUNG CANCER (N= 15), RENAL CELL CARCINOMA (N = 9), COLORECTAL CANCER (N = 5), HEPATOCELLULAR CARCINOMA (N =4), AND OTHER TUMORS (N = 2). REAL-TIME CT FLUOROSCOPY WAS USED TO PLACE THE INTERNALLY COOLED ELECTRODES. THE EVENT RESULTED MAJOR COMPLICATIONS OF ADRENAL FAILURE(1) AND HYPERTENSIVE CRISIS(1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243705 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other