BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL MULTIPURPOSE STEREOTACTIC ARC

    MDR report key: 3057365 · Received April 5, 2013

    Report

    Report Number
    9612186-2013-00001
    Event Type
    Other
    Date Received
    April 5, 2013
    Date of Event
    March 13, 2013
    Report Date
    July 24, 2013
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER IS KNOWN TO BE EXPERIENCED AND THE SYSTEM THEY ARE USING IS BRAND NEW. THE INVESTIGATION INTO THIS INCIDENT IS ON-GOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADD'L INFO TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE FINAL INVESTIGATION CONCLUDE THAT NO MALFUNCTION OR DESIGN ERRORS COULD BE IDENTIFIED ON THE LEKSELL MULTIPURPOSE STEREOTACTIC ARC THAT COULD EXPLAIN THE REPORTED DEVIATION. THE MANUFACTURER CONCLUDES FROM TESTS UNDERTAKEN THAT THE PRODUCT IS PERFORMING AS INTENDED. THIS IS THE MANUFACTURER'S FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEKSELL MULTIPURPOSE STEREOTACTIC ARC SYSTEM SEEMED INACCURATE. IN TWO CASES THE ELECTRODE ENDED UP OFF TARGET. ONE EVENT (SURGERY ON THE LEFT SIDE) THE DEVIATION WAS 2MM POSTERIOR - THIS IS A LARGER DEVIATION THAN EXPECTED. THE SECOND EVENT A PATIENT WAS OPERATED ON THE RIGHT SIDE THE DEVIATION WAS 3MM FOR ONE TREATMENT AND 2.3MM FOR THE SUBSEQUENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140118 LEKSELL MULTIPURPOSE STEREOTACTIC ARC NEUROLOGICAL STEREOTACTIC SURGERY SYSTEM HAW ELEKTA INSTRUMENT AB

    Patients

    Seq Age Sex Outcome Treatment
    1