BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2022579 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00881
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT (B)(6). (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00798 ADDRESSES THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR AND A LEVEEN NEEDLE ELECTRODE WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE IMPEDANCE BECAME UNSTABLE AFTER THE FIFTH ABLATION TREATMENT. THE LEVEEN NEEDLE ELECTRODE WAS WITHDRAWN FROM THE PATIENT AND THE INSULATION WAS FOUND TO HAVE PEELED. IT IS NOT KNOWN IF THE INSULATION PEELED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S ELECTRODE (COOL TIP) AND GENERATOR. A RF 3000 RADIOFREQUENCY GENERATOR COMPLAINT WAS OPENED BASED ON INFORMATION RECEIVED BY THE ACCOUNT ON (B)(6) 2011 WHICH INDICATED THAT ROLL-OFF HAD NOT BEEN ACHIEVED. 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 GOOD.

    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