BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 3213213 · Received July 9, 2013

    Report

    Report Number
    3005099803-2013-06209
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: GENERATOR LOW ENERGY DELIVERY. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EXAMINATION OF THE COMPLAINT DEVICE FOUND CRACKS ON THE IMPEDANCE OVERLAY AND ELECTRODE CONNECTOR, AND THE TAMPER PROOF SEAL WAS PRESENT BUT BROKEN. THE DEVICE PASSED POWER-ON SELF-TEST, RF DELIVERY TEST, AND PRELIMINARY FINAL TESTS WITHOUT REMOVAL OF THE TOP COVER. ADDITIONAL ENVIRONMENTAL STRESS TESTING WAS PERFORMED AT HIGH AND LOW TEMPERATURE AND HIGH AND LOW VOLTAGE MARGIN, AND THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS. WHEN THE TOP ENCLOSURE OF THE DEVICE WAS REMOVED, NO VISIBLE ISSUES WERE NOTICED. AFTER THE FINAL ASSEMBLY THE DEVICE FAILED THE FINAL TEST OF "FRONT PANEL CONTROLS," STEPS STOP AND RESET, DUE TO THE FAILURE OF THE FRONT PANEL BOARD. FOLLOWING REPLACEMENT THERE WERE NO ISSUES FOUND AND THE DEVICE PASSED THE FINAL TEST. THERE WERE ISSUES NOTED TO THE DEVICE, HOWEVER THIS DID NOT CONTRIBUTE TO THE REPORTED EVENT OF LOW POWER OUTPUT, THEREFORE THE COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A RF3000 RADIOFREQUENCY GENERATOR WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR WAS NOT PRODUCING ENOUGH ENERGY AND COULD NOT ABLATE THE TUMOR. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2013 THAT A RF3000 RADIOFREQUENCY GENERATOR WAS USED DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GENERATOR WAS NOT PRODUCING ENOUGH ENERGY AND COULD NOT ABLATE THE TUMOR. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT AND PROCEDURE INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312054 RF3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M00126220Z0

    Patients

    Seq Age Sex Outcome Treatment
    1