BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA KNIFE PERFEXION

    MDR report key: 3842894 · Received June 2, 2014

    Report

    Report Number
    9612186-2014-00003
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    October 8, 2014
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    PMA / PMN Number
    K120811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEKSELL GAMMA KNIFE PERFEXION COORDINATE FRAME IS FIXED TO THE PATIENT POSITIONING SYSTEM BEFORE TREATMENT USING A FRAME ADAPTER. THE COORDINATE FRAME IS LOCKED TO THE FRAME ADAPTER VIA LATCHES. THE LATCHES ARE TURNED NINETY DEGREES AND THEN LOCKED. THE MANUFACTURER'S INVESTIGATION HAVE SHOWN THAT IT MAY BE POSSIBLE TO HAVE A SITUATION WHERE THE ADAPTER LATCHES CAN GET STUCK JUST ABOVE THE COORDINATE FRAME SURFACE AND AS A RESULT THE COORDINATE FRAME WILL NOT BE FIXED PROPERLY. THIS COULD THEN RESULT IN A SMALL PLAY BETWEEN THE COORDINATE FRAME AND THE FRAME ADAPTER IN THE LEKSELL Z-DIRECTION. A SMALL "SHELF" CAN BE CREATED IF THE LATCH HAS BEEN FORCED INTO POSITION WHEN AT A SMALL ANGLE. IF THE LATCH LOCKS TO THAT SHELF THERE WILL BE A PLAY BETWEEN THE FRAME AND THE LATCH, WHICH COULD POSSIBLY MOVE THE TARGET FROM PLANNED POSITION BY UP TO 0.5 MM. THE ROOT CAUSE IS THAT FRAME ADAPTERS HAVE NOT BEEN MANUFACTURED ACCORDING TO SPECIFICATION. A FIELD SAFETY CORRECTIVE NOTICE (100-01-202-027) WILL BE RELEASED TO CUSTOMERS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS CURRENTLY ON-GOING. FURTHER INFORMATION WILL BE PROVIDED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED THAT THEY ARE CONCERNED THAT THE FRAME ADAPTOR IS ABLE TO BE PLACED ON THE QA TOOL WHEN THE LOCKING CLAMPS ARE IN THE INCORRECT POSITION. THERE IS ABOUT 1-2MM OF PLAY. THIS WAS PICKED UP DURING MORNING QA FOCUS CHECK WHEN THE RESULTS CAME BACK FAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320759 LEKSELL GAMMA KNIFE PERFEXION SYSTEM, RADIATION THERAPY, RADIONUCLIDE IWB ELEKTA INSTRUMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1