BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRANIAL NAVIGATION SOFTWARE

    MDR report key: 3354941 · Received September 5, 2013

    Report

    Report Number
    8043933-2013-00026
    Event Type
    Other
    Date Received
    September 5, 2013
    Date of Event
    August 9, 2013
    Report Date
    August 9, 2013
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K092467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSPITAL: THE SURGERY WAS COMPLETED AS INTENDED. NO NORMAL BRAIN TISSUE WAS REMOVED AT THE BIOPSIES. THERE ARE NO NEGATIVE CLINICAL EFFECTS FOR THIS PATIENT DUE TO THIS ISSUE. HOWEVER, IN THIS SPECIFIC CASE THE INFORMATION PROVIDED BY THE BRAINLAB NAVIGATION SYSTEM MISLED THE SURGEON, RESULTING IN BIOPSY ATTEMPTS WITH INCORRECT PATH AND TARGET. A RISK TO PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES. THE INCORRECT USER TECHNIQUE TO DRAPE OVER THE REFERENCE ARRAY CAUSED THE BRAINLAB NAVIGATION SYSTEM TO NOT ACCURATELY DETECT THE REFLECTIVE MARKER POSITIONS ON THE REFERENCE ARRAY. THAT CAUSED A DEVIATION OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION SOFTWARE FROM THE ACTUAL PATIENT ANATOMY POSITION. APPARENTLY THIS SITUATION WAS NOT DETECTED WITH THE NECESSARY ACCURACY VERIFICATION PERFORMED BY THE USER. THE BRAINLAB DEVICE WORKS AS INTENDED. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB NAVIGATION DEVICE. CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ALREADY ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE IN PLACE. BRAINLAB INTENDS TO RE-ITERATE TO THIS HOSPITAL NOT TO DRAPE THE REFERENCE ARRAY OF THE BRAINLAB NAVIGATION SYSTEM.

    Description of Event or Problem · 1

    A BIOPSY OF A CYST IN THE PATIENT'S BRAIN WAS INTENDED TO BE PERFORMED WITH THE AID OF BRAINLAB CRANIAL NAVIGATION SYSTEM. THREE BIOPSY ATTEMPTS WERE PERFORMED, USING THE BRAINLAB NAVIGATION SYSTEM TO ALIGN AND ADVANCE THE BIOPSY NEEDLE TO THE CYST AS GUIDED BY THE VIRTUAL DISPLAY OF THE NAVIGATION. AT THESE 3 ATTEMPTS, NO FLUID OF THE CYST APPEARED FROM THE NEEDLE WHEN ASPIRATING. AFTER THESE ATTEMPTS, THE SURGEON USED ULTRASOUND IMAGING TO VERIFY THE POSITION OF THE CYST, AND DETERMINED THAT THE BIOPSY ATTEMPTS HAD AN INCORRECT PATH AND RESULT IN A TARGET CA 1CM AWAY FROM THE CYST. ACCORDING TO THE HOSPITAL: THIS SURGERY WAS COMPLETED AS INTENDED, USING ULTRASOUND IMAGING. NO NORMAL BRAIN TISSUE WAS REMOVED AT THE BIOPSIES. THERE ARE NO NEGATIVE CLINICAL EFFECTS FOR THIS PATIENT DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440360 CRANIAL NAVIGATION SOFTWARE IMAGE GUIDED SURGERY SYSTEM / STEROT. HAW BRAINLAB AG 22214 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other