BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2192069 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02633
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 13, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, GENDER, AND WEIGHT ARE UNKNOWN. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    ENVIRONMENTAL STRESS TESTING, UNDER CONDITIONS OF HIGH AND LOW TEMPERATURE, HIGH AND LOW MARGIN (SUPPLY) VOLTAGE, AND SHORT-CIRCUIT SHUTDOWN, WAS PERFORMED. THE GENERATOR DID NOT EXHIBIT ANY MALFUNCTION WHICH COULD ACCOUNT FOR THE EVENT. FURTHERMORE, THE DEVICE PASSED ALL PERFORMANCE CRITERIA OF ITS FINAL TEST PROCEDURE.THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THE COMPLAINT WAS NOT CONFIRMED.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GENERATOR ERROR (P4) OCCURRED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR WAS USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GENERATOR ERROR (P4) OCCURRED.THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M001262200

    Patients

    Seq Age Sex Outcome Treatment
    1