BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 8908045 · Received August 19, 2019

    Report

    Report Number
    1717344-2019-01055
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Report Date
    August 19, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE RADIOFREQUENCY ABLATION FOR HEPATOCELLULAR CARCINOMA: 10-YEAR OUTCOME AND PROGNOSTIC FACTORS SOURCE THE AMERICAN JOURNAL OF GASTROENTEROLOGY, VOLUME 107, 2012(569¿577) DATE OF PUBLICATION: 13 DECEMBER 2011. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED ON FEBRUARY 1999 AND DECEMBER 2009, 1,294 (87.1 % ) UNDERWENT PERCUTANEOUS ABLATION, INCLUDING RADIO FREQUENCY ABLATION (RFA). A TOTAL OF 67 COMPLICATIONS WERE ENCOUNTERED. COMPLICATIONS OF THE 2,982 TREATMENTS LISTED INCLUDE LIVER ABSCESS (6), SKIN BURN (1). COMPLICATIONS OCCURRED IN ONLY 2.2% OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702058 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR