BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 9387325 · Received November 27, 2019

    Report

    Report Number
    1717344-2019-01561
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    May 28, 2018
    Report Date
    November 27, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: PROGNOSTIC FACTORS OF RADIOFREQUENCY ABLATION THERAPY FOR LIVER METASTASES FROM COLORECTAL CANCER SOURCE: ADVANCES IN DIGESTIVE MEDICINE. ADV DIG MED. 2019;6:101¿108; RECEIVED: 20 AUGUST 2017, ACCEPTED: 28 MAY 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE, THE PROGNOSTIC FACTORS IN PATIENTS WITH COLORECTAL LIVER METASTASES UNDERGOING RADIOFREQUENCY ABLATION (RFA). BETWEEN 2008 AND 2013, 52 PATIENTS (MALES 34, FEMALE 18 MEAN AGE: 63 YEARS) WITH COLORECTAL LIVER METASTASES TREATED WITH EITHER PERCUTANEOUS RFA (N = 33) OR INTRAOPERATIVE RFA PLUS RESECTION (N = 19) WERE ENROLLED. THE COOL-TIP RADIOFREQUENCY SYSTEM (RADIONICS, (B)(4)V) WAS USED UNDER REAL-TIME ULTRASONOGRAPHIC GUIDANCE USING A 17-GAUGE, 2 OR 3-CM, COOLED-TIP ELECTRODE CONNECTED TO A GENERATOR. TO AVOID A RAPID INCREASE IN INTRATUMORAL PRESSURE, RFA WAS STARTED AT A LOW POWER (60 W), AND POWER WAS INCREASED IN INCREMENTS OF 10 W/MIN. AUTHORS NOTED ¿PRIMARY TECHNICAL SUCCESS WAS ACHIEVED IN 45 (87%) OF THE CASES; 7 CASES HAD FAILURES. THE MAJOR COMPLICATIONS INCLUDED THE FORMATION OF ONE HEPATIC ABSCESSES WITHOUT DRAINAGE AND ONE TRANSIENT HEPATIC DECOMPENSATION WITH JAUNDICE AND ASCITES. THE RATE OF MAJOR COMPLICATION WAS 3.8%. THERE WERE NO PROCEDURE-RELATED DEATHS. ARTICLE: CHUN-HSIEN CHEN, 2019, WILEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181740 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR