BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA KNIFE PERFEXION WITH EXTEND FRAME SYSTEM

    MDR report key: 1851032 · Received September 27, 2010

    Report

    Report Number
    9612186-2010-00005
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    PMA / PMN Number
    K092083
    Removal / Correction Number
    9612186-092710-016-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: A FAILURE OF AN EXTEND MOUTHPIECE WAS FOUND DURING A PT SETUP. THE ANTERIOR FIXATION BAR OF THE FRONTPIECE CAME LOOSE FROM THE DENTAL IMPRESSION TRAY. THE JOINT BETWEEN THE ANTERIOR FIXATION BAR AND THE DENTAL IMPRESSION TRAY IS GLUED USING CYANOACRYLATE GLUE. THE BOND GAP HAS BEEN TOO LARGE IN SOME MOUTHPIECES, RESULTING IN A TOO SMALL CONTACT SURFACE BETWEEN THE TWO PARTS AND AS A CONSEQUENCE A TOO WEAK JOINT. THE RESULT IS THAT THE GLUE LINE CAN BREAK WHEN THE MOUTHPIECE IS TWISTED, WHICH LEADS TO EITHER A PLAY BETWEEN THE ANTERIOR FIXATION BAR AND THE DENTAL IMPRESSION TRAY, OR THAT THE DENTAL IMPRESSION TRAY COMES LOOSE. IT IS NOT POSSIBLE TO DETERMINE IF THE GLUE LINES ON A MOUTHPIECE ARE BAD, NEITHER BY VISUAL INSPECTION NOR BY PULLING OR BENDING THE EXTEND MOUTHPIECE. CORRECTIVE ACTION: ELEKTA INSTRUMENTS (B)(4) ISSUED AN IMPORTANT NOTICE A342 "POTENTIAL FAILURE OF THE EXTEND MOUTHPIECE" TO AFFECTED USERS INSTRUCTING THEM TO RETURN THE OLD MOUTHPIECES TO ELEKTA INSTRUMENTS (B)(4) WHICH WILL BE REPLACED WITH NEW MOUTHPIECES. THE CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED WITHIN THE (B)(4).

    Description of Event or Problem · 1

    DURING SETUP OF PT AT CT, IT WAS DIFFICULT TO ACHIEVE GOOD RESULTS AT RCT MEASUREMENT. THE ROD TURNED OUT TO HAVE LOOSENED FROM THE MOUTHPIECE. ALL MOUTHPIECES AT CUSTOMERS WERE THEN CHECKED BY HAND FORCE PRIOR TO THE NEXT SETUP TRIAL. AFTER CT PRIOR TO TREATMENT, THE SAME THING HAPPENED AGAIN. SIZE OF THE MOUTHPIECE WAS XL P2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1