BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM

    MDR report key: 3913109 · Received May 14, 2014

    Report

    Report Number
    3005594788-2014-00003
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 14, 2014
    Manufacturer
    XOFT, A SUBSIDIARY OF ICAD, INC.
    Product Code
    JAD
    PMA / PMN Number
    K122951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE BRACHYTHERAPY CONTROLLER UNIT (S/N (B)(4)) SOURCE USAGE LOG SHOWED A 31.8% DECREASE IN THE AIR KERMA STRENGTH FROM THE FIRST CALIBRATION OF THE X-RAY SOURCE (S/N (B)(4)), CONSISTENT WITH THE OPERATOR'S CLAIM THAT A SIGNIFICANT REDUCTION IN THE AIR KERMA STRENGTH WAS OBSERVED. THE X-RAY SOURCE WAS RETESTED BY THE MANUFACTURER USING THE SAME TEST SYSTEM FOR THE CERTIFICATION OF THE SOURCES. THE DEVICE WAS PER CYCLED 103 TIMES AND SHOWED NO SIGNIFICANT VARIATION IN OUTPUT. THE CONTROLLER, WELL CHAMBER AND ELECTROMETER WERE RETESTED AND DETERMINED TO BE WITHIN A FRACTION OF 1% OF THEIR ORIGINAL PERFORMANCE MEASUREMENTS. NO OTHER INCIDENCES OF THIS NATURE WERE EVER REPORTED TO THE MANUFACTURER. BASED ON THESE FINDINGS, NO DEFINITIVE ROOT CAUSE WAS DETERMINED FOR THE SIGNIFICANT CHANGE IN THE AIR KERMA STRENGTH OBSERVED BY THE USER. THE BRACHYTHERAPY CONTROLLER UNIT, X-RAY SOURCE, WELL CHAMBER, AND ELECTROMETER ALL PERFORMED TO SPECIFICATION AS VERIFIED BY THE MANUFACTURER. A MANUFACTURING DEVICE HISTORY REVIEW FOUND NO RELATED ANOMALIES INVOLVING THE MANUFACTURING OF THE CONTROLLER, X-RAY SOURCE AND ACCESSORIES.

    Description of Event or Problem · 1

    A PATIENT UNDERWENT TREATMENT FOR BREAST CANCER USING THE XOFT ELECTRONIC BRACHYTHERAPY SYSTEM. THE TREATING FACILITY REPORTED THAT THE PATIENT MAY NOT HAVE RECEIVED THE PRESCRIBED DOSE OF RADIATION DELIVERED BY THE BRACHYTHERAPY CONTROLLER. THE FACILITY INDICATED THAT THE CONTROLLER WAS INADVERTENTLY UNPLUGGED TO REPOSITION THE UNIT IN THE OPERATING ROOM AFTER THE X-RAY SOURCE OF THE CONTROLLER WAS CALIBRATED TO AN AIR KERMA STRENGTH OF 127,557U. AFTER THE CONTROLLER WAS RESTARTED, THE SOURCE WAS RE-CALIBRATED AND READ AN AIR KERMA STRENGTH VALUE OF 86,977U WHICH WAS 31.8% LESS THAN THE PREVIOUS CALIBRATION. THE DEVICE OPERATING INSTRUCTIONS ALERT THE USER TO NOT USE THE SOURCE IF THE CALIBRATED VALUE FOR THE AIR KERMA STRENGTH DIFFERS FROM THE PREVIOUS CALIBRATION BY MORE THAN + 5%. FACILITY PERSONNEL WERE AWARE OF THE OPERATING INSTRUCTIONS BUT PROCEEDED WITH THE PROCEDURE USING THE SOURCE THAT WAS RECALIBRATED AT AN AIR KERMA VALUE OF 86,997U. AFTER THE PROCEDURE WAS PERFORMED AND UPON THE RECOMMENDATION BY THE MANUFACTURER'S SERVICE PERSONNEL, THE FACILITY RECALIBRATED THE SOURCE AND OBSERVED THAT THE AIR KERMA STRENGTH WAS WITHIN + 5% OF THE FIRST CALIBRATION PERFORMED (127,557U). BASED ON THIS OBSERVATION, IT WAS BELIEVED THAT THE PATIENT MAY HAVE RECEIVED A RADIATION DOSE BEYOND THE PRESCRIBED LEVEL FOR THE PROCEDURE. THE MANUFACTURER'S FIELD SERVICE PERSONNEL RAN MOCK TREATMENTS AT THE CUSTOMER'S SITE USING A FIELD SERVICE X-RAY SOURCE ON THE CONTROLLER AND ALL ACCESSORIES AND FOUND NO OPERATION ANOMALIES. THE X-RAY SOURCE, WELL CHAMBER, AND ELECTROMETER WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. THE PATIENT WAS EVALUATED BY THE TREATING PHYSICIAN SEVERAL WEEKS AFTER THE TREATMENT AND SHOWED NO ACUTE SYMPTOMS OF RADIATION EXPOSURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288098 XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM CONTROLLER JAD XOFT, A SUBSIDIARY OF ICAD, INC. 110

    Patients

    Seq Age Sex Outcome Treatment
    1 NI