BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2141704 · Received June 27, 2011

    Report

    Report Number
    3005099803-2011-02194
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT OVER 18 YEARS OLD. THE COMPLAINANT STATED THAT THE DEVICE WILL NOT BE RETURNED; THEREFORE, ANALYSIS OF THE DEVICE CANNOT BE COMPLETED, AND THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. THE PHYSICIAN WAS PERFORMING A BONE ABLATION. THE DIRECTIONS FOR USE (DFU) DOCUMENT INDICATES THAT THE RF 3000 RADIOFREQUENCY GENERATOR AND LEVEEN ELECTRODE ARE INTENDED TO BE USED FOR THERMAL COAGULATION NECROSIS OF SOFT TISSUES, INCLUDING PARTIAL OR COMPLETE ABLATION OF NONRESECTABLE LIVER LESIONS. THE DEVICE IS NOT SPECIFICALLY INDICATED FOR RADIOFREQUENCY ABLATION OF THE BONE. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02195 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN ELECTRODE WERE USED DURING A BONE RFA (RADIOFREQUENCY ABLATION) PROCEDURE OF THE LEFT ANKLE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GENERATOR ERROR (E02) OCCURRED. THE GROUNDING PADS WERE REPLACED AND THE ELECTRODE WAS RE-POSITIONED AND THE ERROR WAS ABLE TO BE CLEARED. 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 OKAY.

    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 M001262200

    Patients

    Seq Age Sex Outcome Treatment
    1