BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2111662 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01865
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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. THE COMPLAINT WAS NOT CONFIRMED. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE/DATE OF BIRTH, AND WEIGHT ARE UNKNOWN. HOWEVER, PATIENT REPORTED TO BE IN HIS LATE FIFTIES. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01863 AND 3005099803-2011-01864 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN NEEDLE ELECTRODE AND A PATIENT RETURN GROUNDING PAD WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, AN OPEN SURGICAL PROCEDURE, LOBECTOMY COMBINED WITH RFA, WAS PERFORMED. AFTER COMPLETING THE LOBECTOMY, THE ABLATION WAS PERFORMED. THE INITIAL TREATMENT WAS ADMINISTERED ON A 4CM LIVER LESION. IF THE BURN WAS SUCCESSFUL, TWO ADDITIONAL SITES WERE TO BE ABLATED. HOWEVER, AFTER APPROXIMATELY 30 MINUTES, A GENERATOR ERROR MESSAGE (E03) OCCURRED. THE ABLATION WAS STOPPED, THE GENERATOR WAS RESET, AND THE ABLATION TREATMENT WAS CONTINUED. SUBSEQUENTLY, A SECOND GENERATOR ERROR (P01) OCCURRED. THE CORRESPONDING PATIENT RETURN GROUNDING PAD (PAD 1) WAS REPLACED AND THE ABLATION WAS CONTINUED. AFTER A TOTAL TREATMENT TIME OF APPROXIMATELY 90 MINUTES, ROLL-OFF HAD NOT BEEN ACHIEVED SO THE ABLATION PROCEDURE WAS ABORTED BY THE PHYSICIAN AND THE TUMORS WERE REMOVED SURGICALLY. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE LEVEEN NEEDLE ELECTRODE. ADDITIONALLY, THERE WERE NO SIGNS THAT THE TISSUE HAD BEEN ABLATED. 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 STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01863 AND 3005099803-2011-01864 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN NEEDLE ELECTRODE AND A PATIENT RETURN GROUNDING PAD WERE USED DURING A LIVER RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, AN OPEN SURGICAL PROCEDURE, LOBECTOMY COMBINED WITH RFA, WAS PERFORMED. AFTER COMPLETING THE LOBECTOMY, THE ABLATION WAS PERFORMED. THE INITIAL TREATMENT WAS ADMINISTERED ON A 4CM LIVER LESION. IF THE BURN WAS SUCCESSFUL, TWO ADDITIONAL SITES WERE TO BE ABLATED. HOWEVER, AFTER APPROXIMATELY 30 MINUTES, A GENERATOR ERROR MESSAGE (E03) OCCURRED. THE ABLATION WAS STOPPED, THE GENERATOR WAS RESET, AND THE ABLATION TREATMENT WAS CONTINUED. SUBSEQUENTLY, A SECOND GENERATOR ERROR (P01) OCCURRED. THE CORRESPONDING PATIENT RETURN GROUNDING PAD (PAD 1) WAS REPLACED AND THE ABLATION WAS CONTINUED. AFTER A TOTAL TREATMENT TIME OF APPROXIMATELY 90 MINUTES, ROLL-OFF HAD NOT BEEN ACHIEVED SO THE ABLATION PROCEDURE WAS ABORTED BY THE PHYSICIAN AND THE TUMORS WERE REMOVED SURGICALLY. REPORTEDLY, THERE WERE NO VISIBLE ISSUES WITH THE LEVEEN NEEDLE ELECTRODE. ADDITIONALLY, THERE WERE NO SIGNS THAT THE TISSUE HAD BEEN ABLATED. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RF3000 RADIOFREQUENCY GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI BOSTON SCIENTIFIC - MARLBOROUGH M00126221D0

    Patients

    Seq Age Sex Outcome Treatment
    1