BEUDAMED
    FDA Adverse Event Summary report: N

    LEKSELL GAMMA KNIFE C1.2

    MDR report key: 1158263 · Received August 16, 2008

    Report

    Report Number
    9612186-2007-00003
    Date Received
    August 16, 2008
    Date of Event
    June 28, 2007
    Report Date
    September 28, 2007
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER UPDATING THE ACTUATOR IN SPARE PART 810361, THE OLD SLEIGH BECAME OBSOLETE DUE TO CAUSING INSUFFICIENT LOCKING OF THE HELMET IN COMBINATION WITH THE NEW ACTUATOR. SOME SITES HAVE HAD THEIR ACTUATOR REPLACED BUT NOT THE SLEIGH, RESULTING IN AN INADEQUATE FIXATION OF THE HELMET. THE CORRECTIVE ACTION IS FIELD CHANGE ORDER (B) (4), RELEASED IN OCTOBER 2007, WHICH TARGETS THE SITES WHERE ONLY THE ACTUATOR HAS BEEN CHANGED TO THE NEW TYPE BUT THE SLEIGH HAS ERRONEOUSLY BEEN LEFT UNCHANGED.

    Description of Event or Problem · 1

    THE ORIGINAL TUBE WAS REPLACED ON THE LINER ACTUATOR OF HELMET LOCK AND UNLOCK AT HELMET CARRIER PART. THE REPLACEMENT TUBE DOES NOT APPEAR TO HAVE THE SAME SPEC AS THE ORIGINAL ONE. THE SPEC OF THE TUBE LENGTH IS 1 CENTIMETER LONGER THAN THE ORIGINAL ONE. AS A RESULT, THE MOVING METAL PART OF THE LOCKING MECHANISM TOUCHES THE OUTER TUBE SO THAT THE LOCKING WINGS CANNOT FULLY OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA KNIFE C1.2 NONE IWB

    Patients

    Seq Age Sex Outcome Treatment
    1