BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1)

    MDR report key: 6348659 · Received February 22, 2017

    Report

    Report Number
    8043933-2017-00006
    Event Type
    Malfunction
    Date Received
    February 22, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 24, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    UDI-DI
    04056481000493
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE ELECTRODES WERE PLACED IN LOCATIONS IN THE PATIENT'S BRAIN DIFFERENT THAN PLANNED WITH THE BRAINLAB NAVIGATION DEVICE INVOLVED, DESPITE ACCORDING TO THE SURGEON: - THE RESULTS OF THE SURGERY WERE STILL IN ACCORDANCE WITH EXPECTATION. - THERE WERE NO NEGATIVE EFFECTS TO THE PATIENT, AND THERE WAS NO PROLONG OF THE SURGERY/ANESTHESIA DUE TO THIS ISSUE. - THERE ARE NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE. ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE FOR THE DEVIATIONS OF THE ACTUAL POSITIONS OF THE ELECTRODES FROM THE PLANNED POSITIONS IS A SUBOPTIMAL PATIENT REGISTRATION FOR NAVIGATION, THAT WAS APPARENTLY NOT DETECTED BY THE USER WITH THE NECESSARY VERIFICATION OF NAVIGATION ACCURACY. FURTHER CONTRIBUTING FACTORS: - THE NAVIGATION IR CAMERA WAS PLACED OUTSIDE THE RECOMMENDED DISTANCE TO THE REFERENCE ARRAY (PLACED TOO CLOSE). - ONE OF THE HOSPITAL'S REFERENCE ARRAY FOR NAVIGATION HAS A BENT PIN, THAT MIGHT CONTRIBUTE TO A DEVIATION. IT CANNOT BE EXCLUDED THAT THIS REFERENCE ARRAY WAS USED AT THIS SURGERY. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION). CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 1

    A CRANIAL SURGERY FOR A IMPLANTATION OF 8 SEEG ELECTRODES (TO TREAT EPILEPSY) INTO THE PATIENT'S BRAIN, HAS BEEN PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION VERSION 2.1.1. PRE-OPERATIVE CT SCANS (CT AND CT ANGIO) WERE ACQUIRED 4 DAYS BEFORE THE SURGERY, TO USE WITH NAVIGATION. TRAJECTORIES FOR THE ELECTRODES WERE PLANNED ON THE PRE-OP CT SCANS AND MRI SCANS BEFORE THE SURGERY WITH THE BRAINLAB IPLAN PLANNING SW. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A PRONE ORIENTATION IN A (NON-BRAINLAB) HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH SURFACE MATCHING TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS VERY GOOD. - CREATED THE BURR HOLES, AND PLACED THE 8 ELECTRODES WITH AID OF NAVIGATION. A POST-OP CT SCAN WAS PERFORMED, AND THE SURGEON DETERMINED THAT THE ELECTRODE LOCATIONS DIFFERED BY CA. 3MM TO CA. 6MM FROM THE INTENDED TARGET LOCATIONS. ACCORDING TO THE SURGEON: - THE RESULTS OF THE SURGERY WERE STILL IN ACCORDANCE WITH EXPECTATION. - THERE WERE NO NEGATIVE EFFECTS TO THE PATIENT, AND THERE WAS NO PROLONG OF THE SURGERY/ANESTHESIA DUE TO THIS ISSUE. - THERE ARE NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132707 CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC HAW BRAINLAB AG 22214A SW V. 2.1.1 04056481000493

    Patients

    Seq Age Sex Outcome Treatment
    1 Other