BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RF3000 RADIOFREQUENCY GENERATOR

    MDR report key: 2162383 · Received July 14, 2011

    Report

    Report Number
    3005099803-2011-02376
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEI
    PMA / PMN Number
    K000241
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FUNCTIONAL ANALYSIS SHOWED THAT THE ERROR (H07) OCCURRED DURING POST (POWER ON SELF-TEST). THE INVESTIGATION CONCLUDED THAT THE ERROR WAS ATTRIBUTABLE TO A COMPONENT ON THE RF BOARD. FOLLOWING REPLACEMENT, THE DEVICE PASSED ALL PERFORMANCE CRITERIA OF ITS FINAL TEST PROCEDURE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT A CONSOLE ERROR (H07) OCCURRED. BASED ON THE EVALUATION, THE FAILURE WAS ATTRIBUTED TO A COMPONENT ON THE RF BOARD. THEREFORE, THE MOST LIKELY ROOT CAUSE OF THIS DAMAGE IS WEAR AND TEAR (EXTENDED USE). A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED SERIAL NUMBER. (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR WAS TO BE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE GENERATOR WAS UNPACKED AND CONNECTED, BUT AN ERROR (H07) OCCURRED. THE TECHNICIAN TRIED TO CLEAR THE ERROR WITHOUT SUCCESS. THE PHYSICIAN WAS NOTIFIED AND OPTED TO COMPLETE THE CASE VIA SURGERY. 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 TO BE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, PRIOR TO THE PROCEDURE, THE GENERATOR WAS UNPACKED AND CONNECTED, BUT AN ERROR (H07) OCCURRED. THE TECHNICIAN TRIED TO CLEAR THE ERROR WITHOUT SUCCESS. THE PHYSICIAN WAS NOTIFIED AND OPTED TO COMPLETE THE CASE VIA SURGERY. 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