BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSELECTRON HDR-V2

    MDR report key: 1387405 · Received March 24, 2009

    Report

    Report Number
    9611894-2009-00004
    Event Type
    Malfunction
    Date Received
    March 24, 2009
    Date of Event
    January 20, 2009
    Report Date
    March 23, 2009
    Manufacturer
    NUCLETRON BV
    Product Code
    JAQ
    PMA / PMN Number
    K953946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TO INVESTIGATE THE PROBLEM, THE ENGINEER DISASSEMBLED THE DRIVE MECHANISM AND FOUND THE GROOVES IN ONE AREA OF THE CABLE DRUM WERE "MASHED" WHICH CAUSED THE SOURCE CABLE TO IMPROPERLY ALIGN IN THE GROOVES AND JAM. IN ADDITION, SEVERAL TEETH ON THE GEAR WHEEL WERE ALSO DAMAGED. THIS DAMAGE APPEARS TO HAVE BEEN CAUSED WHEN THE EMERGENCY STOP FUNCTION WAS ENGAGED BUT WAS UNSUCCESSFUL IN RETRACTING THE JAMMED SOURCE CABLE, THUS CAUSING EXTREME WEAR ON THE GEAR. THE UNIT WAS CLEANED AND THE CABLE DRUM AND GEAR WHEEL WERE REPLACED. THE SYSTEM WAS TESTED REPEATEDLY AND FOUND TO BE FUNCTIONING PROPERLY. THE CABLE DRUM AND GEAR WHEEL WILL BE EXAMINED CLOSELY DURING THE NEXT SOURCE EXCHANGE TO LOOK FOR ANY UNUSUAL WEAR.

    Description of Event or Problem · 1

    THE FIELD SERVICE ENGINEER ENCOUNTERED A PROBLEM WITH THE DRIVE MECHANISM DURING A QUARTERLY SOURCE EXCHANGE. THIS PROHIBITED THE SOURCE FROM FULLY DEPLOYING INTO THE TRANSPORT CONTAINER OR RETRACTING BACK INTO THE SAFE. EMERGENCY PROCEDURES WERE FOLLOWED ALLOWING THE SOURCE TO BE INSERTED INTO THE EMERGENCY CONTAINER. THE ENGINEER WAS EXPOSED TO A SLIGHTLY GREATER THAN TYPICAL DOSE WHICH WAS WELL WITHIN THE REGULATORY LIMIT FOR OCCUPATIONAL EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSELECTRON HDR-V2 HDR REMOTE AFTERLOADER JAQ NUCLETRON BV

    Patients

    Seq Age Sex Outcome Treatment
    1