BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKSELL VANTAGE STEREOTACTIC SYSTEM

    MDR report key: 16041678 · Received December 23, 2022

    Report

    Report Number
    9612186-2022-00003
    Event Type
    Malfunction
    Date Received
    December 23, 2022
    Date of Event
    December 12, 2022
    Report Date
    March 10, 2023
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    HAW
    UDI-DI
    07340048304399
    PMA / PMN Number
    K190887
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D8 UPDATED. H6 UPDATED. H10 UPDATED: THE ISSUE REPORTED BY THE CUSTOMER WAS THAT THE LEKSELL VANTAGE STEREOTACTIC SYSTEM HAD A TARGET SHIFT OF MORE THAN 2MM. THIS SITE IS USING A MICRODRIVE SUPPLIED BY A THIRD PARTY (ALPHA OMEGA) IN CONJUNCTION WITH THE LEKSELL VANTAGE STEREOTACTIC SYSTEM. THE LEKSELL VANTAGE STEREOTACTIC SYSTEM HAS BEEN INVESTIGATED REGARDING MECHANICAL ACCURACY AND IT IS WELL WITHIN SPECIFICATION. ELEKTA INSTRUMENT AB HAVE ALSO INVESTIGATED THE USED MICRODRIVE (ALPHA OMEGA) TOGETHER WITH THE LEKSELL VANTAGE STEREOTACTIC SYSTEM AND THE INVESTIGATION CONCLUDED THAT MICRODRIVE (ALPHA OMEGA) IS INCORRECTLY INTERFACING THE LEKSELL VANTAGE STEREOTACTIC SYSTEM IN A WAY THAT IT MAY CAUSE A SIGNIFICANT SHIFT BOTH ANTERIOR AND LATERAL (ACCURACY ERROR). THIS SHIFT IS SEEN FOR THE SYSTEM TESTED ONLY AND IS JUDGED TO BE HIGHLY DEPENDENT ON THE COMBINATION OF MICRODRIVE (ALPHA OMEGA) MEASUREMENTS AND THE STOP HOLDER MEASUREMENTS. THE RESULT WAS PRESENTED TO THE USER WHO CONFIRMS THAT THE DIRECTION IS THE SAME AS THEY HAVE SEEN DURING THEIR PROCEDURES AS WELL AS DURING PHANTOM TESTS. TESTS WERE ALSO REPEATED WITH THE LEKSELL VANTAGE STEREOTACTIC SYSTEM USING ELEKTA MICRODRIVE WHICH SHOW MUCH BETTER ACCURACY (WITHIN SPECIFICATION) THAN USING THE ALPHA OMEGA MICRODRIVE DUE TO CORRECT INTERFACING TO THE SYSTEM. THE ROOT CAUSE COULD THEREFORE BE CONCLUDED TO BE CAUSED BY INCOMPATIBILITY BY A THIRD PARTY PRODUCT. ALPHA OMEGA IS CLAIMING COMPATIBILITY WITH ALL ELEKTA INSTRUMENT AB'S STEREOTACTIC SYSTEMS ON THE MARKET. ELEKTA INSTRUMENT AB HAS ON SEVERAL OCCASIONS INFORMED ALPHA OMEGA THAT INTERFACING TOWARDS ONLY THE STOP HOLDER IS INCORRECT AND WILL CAUSE ACCURACY ISSUES. ELEKTA INSTRUMENT AB RECOMMENDED ALPHA OMEGA TO REVIEW THEIR INTERFACING DESIGN AND STATED THAT ALPHA OMEGA CANNOT CLAIM COMPATIBILITY WITH ELEKTA INSTRUMENT AB'S STEREOTACTIC SYSTEMS. LEKSELL VANTAGE STEREOTACTIC SYSTEM INHIBITED SAFELY AND THERE HAVE BEEN NO PATIENT INJURIES. PLEASE NOTE THAT THERE ARE TWO CASES REPORTED FROM THE SAME USER USING THE SAME SYSTEM SINCE IT WAS USED TWICE WHERE A DISCREPANCY WAS SEEN (ELEKTA REF. #(B)(4) - MFR NO 9612186-2022-00004).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ACCURACY DEVIATIONS WITH LEKSELL VANTAGE DURING SURGERY WITH A SYSTEMATIC ERROR OF ABOUT 1.6 MM. THE CUSTOMER WAS USING THE NON-COMPATIBLE MICRODRIVE FROM THE MANUFACTURER ALPHA-OMEGA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2782792 LEKSELL VANTAGE STEREOTACTIC SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW ELEKTA INSTRUMENT AB 1053958 07340048304399

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown