BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9787066 · Received March 4, 2020

    Report

    Report Number
    1717344-2020-00243
    Event Type
    Malfunction
    Date Received
    March 4, 2020
    Date of Event
    October 1, 2015
    Report Date
    March 4, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE RADIOFREQUENCY ABLATION OF STAGE IA NON-SMALL CELL LUNG CANCER IN MEDICALLY INOPERABLE PATIENTS: RESULTS FROM THE AMERICAN COLLEGE OF SURGEONS ONCOLOGY GROUP Z4033 (ALLIANCE) TRIAL. SOURCE CANCER, VOLUME 121, 2015(1-23) ARTICLE NUMBER: 19 DATE OF PUBLICATION: 1 OCTOBER 2015. 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 LAST DECEMBER 2006 TO NOVEMBER 2010, IN A STUDY EVALUATED THE TWO-YEAR OVERALL SURVIVAL (OS), ADVERSE EVENT RATE, LOCAL CONTROL RATE AND IMPACT ON PULMONARY FUNCTION TESTS (PFTS) IN MEDICALLY INOPERABLE PATIENTS WITH STAGE IA NSCLC (NON-SMALL CELL LUNG CANCER) UNDERGOING CT-GUIDED RFA (RADIOFREQUENCY ABLATION) IN A PROSPECTIVE MULTI-CENTER TRIAL. 54 PATIENTS M:F=25:29, MEDIAN AGE/RANGE= 76/60-89 WERE ENROLLED FROM 16 US CENTERS 51 PATIENTS WERE ELIGIBLE (BIOPSY PROVEN STAGE IA NSCLC AND DEEMED MEDICALLY INOPERABLE BY BOARD CERTIFIED THORACIC SURGEON) FOR EVALUATION. PFTS WERE OBTAINED WITHIN 60 DAYS OF RFA, 3 AND 24 MONTHS AFTER RFA. ALL PATIENTS WERE TREATED WITH A COVIDIEN CLUSTER COOL-TIP ELECTRODE (COVIDIEN, BOULDER, CO) UNDER CT-GUIDANCE ACCORDING TO THE MANUFACTURER¿S SPECIFICATIONS. OUT OF 54 PATIENTS, 1 HAD FEVER, 1 HAD PNEUMONITIS AND 1 HAD HYPOXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251471 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR