BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 5285800 · Received December 10, 2015

    Report

    Report Number
    2134265-2015-08587
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 19, 2015
    Report Date
    November 19, 2015
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT (CE)
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2015-08536 . IT WAS REPORTED THAT INSUFFICIENT ROLL-OFF OCCURRED. THE PATIENT WAS UNDERGOING RADIOFREQUENCY ABLATION (RFA) OF THE LIVER UTILIZING A RF3000 RADIOFREQUENCY GENERATOR AND A 3.5/15/15 LEVEEN STANDARD ELECTRODE. IT WAS NOTED THAT ONLY THE AREA AROUND THE NEEDLE WAS BEING BURNED. THE PHYSICIAN INCREASED POWER TO 180W FOR 15 MINUTES; HOWEVER ROLL-OFF WAS NOT ACHIEVED. THE NEEDLE WAS MOVED AND ABLATION WAS CONTINUED, BUT IT WAS STILL NOT SUCCESSFUL. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME LEVEEN STANDARD ELECTRODE AND THE SAME PADS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817456 RF3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - FREMONT (CE) M001262210 0010710011

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR