BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL GAMMA KNIFE

    MDR report key: 1054231 · Received May 29, 2008

    Report

    Report Number
    9612186-2008-00005
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Date of Event
    February 27, 2008
    Report Date
    May 28, 2008
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: ACTUATOR MFR MADE UNAUTHORIZED COMPONENT MATERIAL CHANGE RESULTING IN COMPONENT FAILURE DURING USE. THIS SITE'S PART FAILURE WAS DIRECTLY RELATED TO THE MATERIAL CHANGE. COMPONENT MATERIAL HAS BEEN CORRECTED BY SUBCONTRACTOR AND NEW COMPONENT REPLACEMENT INITIATED (SEE BELOW). CORRECTIVE ACTION: TECHNICAL NOTE "SAFETY ISSUE WITH HELMET HOIST ACTUATOR" AND FIELD CHANGE ORDER, "INVESTIGATION AND CORRECTION OF HELMET CHANGER ACTUATORS" WERE BOTH RELEASED AS CORRECTIVE ACTIONS TO ADDRESS THIS ISSUE. TECHNICAL NOTE SERVES AS A CAUTION TO USERS OF THE GAMMA KNIFE UNITS UNTIL SUCH TIME AS THE PERMANENT FIX CAN BE INSTALLED. FIELD CHANGE ORDER IS THE PERMANENT FIX ISSUES, AND INCLUDES SPECIFIC SERIAL NUMBERS OF MACHINES THAT WERE AFFECTED. AT THIS PARTICULAR SITE, A NEW ACTUATOR WAS INSTALLED AS PART OF THE CORRECTIVE ACTION ASSOCIATED WITH FIELD CHANGE ORDER. INSTALLATION OF THE NEW ACTUATOR SUCCESSFULLY ADDRESSED THE PROBLEMS SEEN EARLIER.

    Description of Event or Problem · 1

    IT WAS DISCOVERED THAT THE ACTUATOR, PART NUMBER 1005050, WAS NOT HOLDING THE HELMET. THIS USER HAD ALREADY RECEIVED A NEW ACTUATOR UPGRADE AS PART OF FCO 0000748, BUT THE ACTUATOR WAS WORN OUT AFTER APPROX TWO MONTHS OF USE. THIS PART WAS REPLACED WITH ANOTHER ACTUATOR ARM FROM FCO KIT #0000748.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1