BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2222746 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02891
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO VISIBLE ISSUES. 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 ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER. A LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4):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 # 3005099803-2011-02890 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 LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE ABLATION TREATMENT WAS ADMINISTERED FOLLOWING THE 4CM ELECTRODE ALGORITHM AND ROLL-OFF WAS SUCCESSFULLY ACHIEVED AFTER APPROXIMATELY 43 MINUTES. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, UPON REMOVAL OF THE PATIENT GROUNDING PADS (BOVIE), A 1.5 INCH CIRCULAR BURN WAS NOTED ON THE PATIENT'S LEFT THIGH. THE BURN SEVERITY WAS REPORTED AS BEING 2ND TO 3RD DEGREE. THE PATIENT WAS HOSPITALIZED, THEN GIVEN A MORPHINE PUMP FOR PAIN. IT IS NOT KNOWN IF ANY ADDITIONAL INTERVENTION WAS REQUIRED TO TREAT THE BURNS. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE LEVEEN COACCESS ELECTRODE SYSTEM.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-02890 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 LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE ABLATION TREATMENT WAS ADMINISTERED FOLLOWING THE 4CM ELECTRODE ALGORITHM AND ROLL-OFF WAS SUCCESSFULLY ACHIEVED AFTER APPROXIMATELY 43 MINUTES. HOWEVER, AT THE CONCLUSION OF THE PROCEDURE, UPON REMOVAL OF THE PATIENT GROUNDING PADS (BOVIE), A 1.5 INCH CIRCULAR BURN WAS NOTED ON THE PATIENT'S LEFT THIGH. THE BURN SEVERITY WAS REPORTED AS BEING 2ND TO 3RD DEGREE. THE PATIENT WAS HOSPITALIZED, THEN GIVEN A MORPHINE PUMP FOR PAIN. IT IS NOT KNOWN IF ANY ADDITIONAL INTERVENTION WAS REQUIRED TO TREAT THE BURNS. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE LEVEEN COACCESS ELECTRODE SYSTEM.

    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 81 YR Hospitalization| R