BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 1823939 · Received September 2, 2010

    Report

    Report Number
    3005099803-2010-03643
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.(B)(4)

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-03642 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN COACCESS ELECTRODE SYSTEM WERE USED DURING A RENAL RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE ELECTRODE WAS POSITIONED IN THE TUMOR UNDER CT GUIDANCE USING THE COAXIAL CANNULA PROVIDED. HOWEVER, AFTER POWERING ON THE GENERATOR AND PROCEEDING WITH THE ABLATION, A CONSOLE ERROR (E02, H1) OCCURRED. THE NEEDLE WAS REDEPLOYED AND THE GROUNDING PADS WERE CHANGED, BUT THE PROBLEM PERSISTED. A SECOND LEVEEN COACCESS ELECTRODE SYSTEM WAS THEN ADVANCED TO THE ORIGINAL LOCATION AND THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED. THE ACCOUNT CONFIRMED THAT THE APPROPRIATE ELECTRODE ALGORITHM WAS FOLLOWED DURING THE ABLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262210

    Patients

    Seq Age Sex Outcome Treatment
    1