BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA KNIFE PERFEXION

    MDR report key: 3814743 · Received May 16, 2014

    Report

    Report Number
    9612186-2014-00002
    Event Type
    Malfunction
    Date Received
    May 16, 2014
    Date of Event
    May 16, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    PMA / PMN Number
    K063512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE LEKSELL GAMMA KNIFE® PERFEXION HAS A REDUNDANT POSITIONING AND MEASURING SYSTEM CONSISTING OF BOTH AN ABSOLUTE OPTICAL LINEAR SCALE AND A RELATIVE ROTARY ENCODER FOR EACH AXIS AND SECTOR. DURING SYSTEM INITIALIZATION BOTH OF THESE MEASUREMENT SYSTEMS ARE VERIFIED TO MATCH STORED VALUES FOR CERTAIN PREDEFINED PHYSICAL POSITIONS. ANY DIFFERENCE BEYOND THE SET TOLERANCE (C:A 50UM) WILL RESULT IN AN ERROR MESSAGE AND A SYSTEM THAT IS UNUSABLE FOR TREATMENT. DURING TREATMENT THE MOTOR SERVOS USE THE ROTARY ENCODER VALUES TO MONITOR AND DRIVE THE MOTORS WHILE THE LINEAR SCALES ARE USED BY THE ELEKTA CONTROL UNIT (ECU) TO VERIFY THE ACCELERATION, SPEED AND POSITION. ANY DIFFERENCE BEYOND THE DEFINED VALUES WILL TERMINATE THE TREATMENT AND RETURN THE SYSTEM TO A SAFE STATE BY BYPASSING ALL NORMAL SERVOS AND SOFTWARE, USING THE "SAFETY SYSTEM". IN ADDITION THERE IS REDUNDANT SOFTWARE IN THE CONTROL SYSTEM SOFTWARE THAT CONTINUOUSLY VERIFIES THE HEALTH AND RESPONSIVENESS OF THE SUB COMPONENTS TO ENSURE THAT ANY PROBLEM IS DETECTED IMMEDIATELY AND THE SAFETY SYSTEM INVOKED. IF ONE, SEVERAL OR ALL SECTORS SEIZE DUE TO A MECHANICAL FAILURE THE SYSTEM WILL DETECT THIS IMMEDIATELY AND BEGIN EMERGENCY EXIT OF THE PATENT FROM THE RADIATION UNIT (RU) AND CLOSE THE SHIELDING DOORS. IT IS KNOWN THAT NORMAL WEAR AND TEAR WILL CAUSE THE SECTORS TO VIBRATE AND CAUSE NOISE DURING MOVEMENT, THIS IS NOT CONSIDERED A HAZARD. SHOULD THE SECTORS SEIZE UP, E.G. IN "BEAM-ON" POSITION, THE CONTROL SYSTEM WILL DETECT THIS AND RETURN THE PATIENT TO A SAFE STATE.

    Description of Event or Problem · 1

    THERE HAS BEEN NO ADVERSE EVENT. THE CUSTOMER HAS REPORTED THAT THE BEARINGS IN SECTOR 3 ARE SQUEAKING AFTER IMPLEMENTATION OF FCO 202 025. THERE IS NO ACCESS TO THE PARTS CONSIDERING THE PRESENCE OF COBALT 60 SOURCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294448 LEKSELL GAMMA KNIFE PERFEXION SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1