BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9799101 · Received March 6, 2020

    Report

    Report Number
    1717344-2020-00255
    Event Type
    Malfunction
    Date Received
    March 6, 2020
    Date of Event
    July 11, 2017
    Report Date
    March 6, 2020
    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 · 1

    (B)(4). TITLE RANDOMIZED CLINICAL TRIAL OF HEPATIC RESECTION VERSUS RADIOFREQUENCY ABLATION FOR EARLY-STAGE HEPATOCELLULAR CARCINOMA. SOURCE BR J SURG, VOLUME 104, 2017(1775-1784) ARTICLE NUMBER: 13 DATE OF ONLINE PUBLICATION: 1 NOV 2017. 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 JULY 2002 TO JUNE 2007, IN A RANDOMIZED TRIAL AIMED TO TEST THE HYPOTHESIS THAT RADIOFREQUENCY ABLATION (RFA) IS SUPERIOR TO HEPATIC RESECTION IN TERMS OF LOWER TUMOUR RECURRENCE RATE AND BETTER LONG-TERM SURVIVAL. PATIENTS WITH EARLY-STAGE HEPATOCELLULAR CARCINOMA HCC (SOLITARY TUMOUR NO LARGER THAN 5 CM; OR NO MORE THAN 3 TUMOURS, EACH 3 CM OR SMALLER) WERE RANDOMIZED INTO HEPATIC RESECTION AND RFA GROUPS. RFA WAS PERFORMED USING AN INTERNALLY COOLED ELECTRODE. OUT OF 109 PATIENTS IN THE RFA GROUP, 1 HAD PNEUMONIA, 2 WITH PEPTIC ULCER, 3 WITH UNSPECIFIED POST-OPERATIVE COMPLICATIONS AND ANOTHER HAD ITS WOUND INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265656 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR