BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSEED DS

    MDR report key: 808536 · Received October 16, 2006

    Report

    Report Number
    1937649-2006-00006
    Event Type
    Malfunction
    Date Received
    October 16, 2006
    Date of Event
    August 11, 2006
    Report Date
    October 13, 2006
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS, INC.
    Product Code
    IWJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS ISSUE WAS EXTENSIVE AND INCLUDED BOTH AN ONSITE VISIT AS WELL AS RETURN OF THE DEVICE TO CMS FOR FURTHER EVALUATION. THE CUSTOMER'S INITIAL REPORT STATED THAT THE SEEDS WERE MISPLACED BY 3CM. HOWEVER, INVESTIGATION REVEALED THAT THE OVEREXTENDED KNOB ACCOUNTED FOR ONLY HALF THE ERROR. IT IS POSSIBLE THAT MISCALIBRATION ACCOUNTED FOR THE OTHER HALF, THOUGH THE CUSTOMER INDICATED THAT CALIBRATION HAD BEEN VERIFIED AND WAS ACCURATE. IT WAS A KNOWN POSSIBILITY THAT THE USER COULD BREAK THE STEPPER BY OVERTURNING THE KNOB. AN EARLIER VERSION OF THE ATTACHED CUSTOMER ADVISORY HAD WARNED USERS ABOUT THIS POSSIBILITY. WHAT WAS NOT KNOWN WAS THAT THIS COULD RESULT IN THE INTERPLANT BRACHYTHERAPY TREATMENT PLANNING SOFTWARE, WITH WHICH THE ACCUSEED DS WAS BEING USED, TO INCORRECTLY REPORT THE EXPOSED NEEDLE DISTANCE. THIS IS NOT INCORRECT FUNCTIONING FOR INTERPLANT; IT IS A RESULT OF THE CUSTOMER USING A BROKEN ACCUSEED SYSTEM. AN ADDITIONAL COMPLICATING FACTOR IN THIS SITUATION WAS THAT THE USER WAS REFERENCING ONLY THE EXPOSED NEEDLE DISTANCE IN PLACING THE SEEDS; THIS IS NOT STANDARD PRACTICE. WHILE CMS FEELS THAT THIS WAS CLEARLY A CASE OF USER ERROR, WE CHOSE TO REPORT IT TO FDA AND INITIATE A VOLUNTARY RECALL BECAUSE THIS CUSTOMER'S REPORT WOULD SEEM TO INDICATE THAT THE POTENTIAL FOR MISTREATMENT IF THE USER DOES MAKE THIS ERROR IS GREATER THAN INITIALLY ANTICIPATED. THE ATTACHED CUSTOMER ADVISORY IS BEING SENT TO ALL ACCUSEED DS CUSTOMERS. THE ADVISORY TELLS CUSTOMERS TO PERFORM A TEST TO ENSURE THAT THE SYSTEM IS FUNCTIONING PROPERLY BEFORE EACH PROCEDURE. CMS IS CURRENTLY MODIFYING THE DESIGN TO FURTHER MITIGATE THE RISK OF A USER OVERTURNING THE KNOB, AND A VOLUNTARY RECALL WILL BE INITIATED TO REWORK ALL ACCUSEED DS SYSTEMS ACCORDINGLY.

    Description of Event or Problem · 1

    A USER WAS PERFORMING A PROCEDURE INVOLVING THE IMPLANTING OF RADIOACTIVE SEEDS INTO THE PROSTATE FOR BRACHYTHERAPY. AFTER PLACING SEVERAL OF THE SEEDS, THE RADIATION ONCOLOGIST AND UROLOGIST CONCLUDED THAT THE SEEDS HAD BEEN MISPLACED. THE SEEDS WERE RETRACTED, AND THE PATIENT WAS NOT HARMED. INVESTIGATION REVEALED THAT THE USER HAD INADVERTANTLY OVERTURNED THE IN/OUT ADJUSTMENT KNOB, CAUSING THE ENCODER TO LOSE ITS CALIBRATED ZERO POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSEED DS BRACHYTHERAPY STEPPER/STABILIZER IWJ COMPUTERIZED MEDICAL SYSTEMS, INC. 1-2174 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA