BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)

    MDR report key: 6799855 · Received August 17, 2017

    Report

    Report Number
    8043933-2017-00023
    Event Type
    Malfunction
    Date Received
    August 17, 2017
    Date of Event
    July 19, 2017
    Report Date
    July 21, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    UDI-DI
    04056481000479
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A CRANIOTOMY WAS PERFORMED WITH THE BRAINLAB DEVICE INVOLVED, WITH HEMORRHAGE AND BEGINNING THROMBOSIS CAUSED BY THE UNINTENDED LOCATION THE BONE FLAP WAS MADE, LEADING TO ABORTION OF THE SURGERY, DESPITE ACCORDING TO THE HOSPITAL: - THERE WERE NO FURTHER INVASIVE SURGERY STEPS DONE WITH AID OF NAVIGATION AFTER BONE FLAP. - THE BONE FLAP WAS REPLACED TO SKULL AT ABORTION OF THIS SURGERY. ABORTION OF SURGERY WAS SUCCESSFUL. - PATIENT HAS A POST-OPERATIVE VISUAL DETRIMENT, BUT ACCORDING TO THE SURGEON IS EXPECTED TO GO AWAY WITH TIME. - THERE ARE NO FURTHER NEGATIVE EFFECTS REPORTED, NEITHER DUE TO ANESTHESIA TIME (OF CA. 1.5 H). - THERE ARE NO REPORTED FURTHER REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT - THERE WAS ALSO NO PROLONGED HOSPITALIZATION REPORTED 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 DISCREPANCY OF THE DISPLAY BY NAVIGATION AND THE PATIENT'S OBSERVED ANATOMY IS THAT THE NAVIGATION REFERENCE ARRAY HAS MOST LIKELY MOVED DURING THE SURGERY (AND THE PATIENT'S HEAD IN THE HEAD HOLDER MIGHT HAVE MOVED ALSO), DUE TO A NOT SUFFICIENT RIGID FIXATION. A FURTHER, TO A LESSER EXTENT CONTRIBUTING FACTOR TO THE DISCREPANCY MIGHT HAVE BEEN THE UNSTERILE MARKER SPHERES USED ON THE INSTRUMENTS DURING REGISTRATION AND (DIRECT) VERIFICATION OF REGISTRATION WERE NOT NEW/UNUSED AS REQUIRED. APPARENTLY THE DISCREPANCY WAS NOT RECOGNIZED BEFORE THE CRANIOTOMY DURING THE NECESSARY CONTINUED VERIFICATION OF ACCURACY THROUGHOUT THE PROCEDURE. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION) CONTRIBUTING TO THIS ISSUE AT THIS SURGERY. 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

    AN OPEN CRANIAL SURGERY FOR RESECTION OF A TUMOR IN THE BRAIN -LOW GRADE GLIOMA, IN CA. 3 CM DEPTH- WAS INTENDED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1. A PRE-OPERATIVE MRI WAS ACQUIRED 9 DAYS BEFORE THE SURGERY TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN PRONE ORIENTATION IN A NON-BRAINLAB HEAD HOLDER. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. THE REGISTRATION RESULT SHOWED GOOD PRECISION. - VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS, AND JUDGED THE ACCURACY ACHIEVED TO BE GOOD (ACCEPTABLE FOR USE FOR THIS CASE). - DRAPED THE PATIENT, AND NAVIGATION REFERENCE ARRAY WAS EXCHANGED TO A STERILE ARRAY. - PERFORMED THE CRANIOTOMY (CA. 2 CM BONE FLAP) WITH AID OF NAVIGATION. AFTER THE CRANIOTOMY, HEMORRHAGE OCCURRED CAUSED BY THE LOCATION THE BONE FLAP WAS MADE. THE BONE FLAP WAS MADE INADVERTENTLY OVER THE SINUS. THROMBOSIS BECAME EVIDENT. THE SINUS WAS OCCLUDED INTRAOPERATIVELY IN ORDER TO DETER FURTHER THROMBOSIS. THE SURGERY WAS ABORTED AT THAT STAGE AND BONE FLAP REPLACED TO SKULL. IN THE POST-OPERATIVE MRI THE SURGEON NOTICED THAT THE BONE FLAP HAD BEEN MADE CA. 15 MM SUPERIOR TO THE INTENDED POSITION. ACCORDING TO THE HOSPITAL: - THERE WERE NO FURTHER INVASIVE SURGERY STEPS DONE WITH AID OF NAVIGATION AFTER BONE FLAP. - THE BONE FLAP WAS REPLACED TO SKULL AT ABORTION OF THIS SURGERY. ABORTION OF SURGERY WAS SUCCESSFUL. - PATIENT HAS A POST-OPERATIVE VISUAL DETRIMENT, BUT ACCORDING TO THE SURGEON IS EXPECTED TO GO AWAY WITH TIME. - THERE ARE NO FURTHER NEGATIVE EFFECTS REPORTED, NEITHER DUE TO ANESTHESIA TIME (OF CA. 1.5 H). - THERE ARE NO REPORTED FURTHER REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT - THERE WAS ALSO NO PROLONGED HOSPITALIZATION REPORTED DUE TO THIS ISSUE. - REVISION SURGERY FOR THIS PATIENT HAD NOT OCCURRED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580269 CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC HAW BRAINLAB AG 22216A SW V. 3.1 04056481000479

    Patients

    Seq Age Sex Outcome Treatment
    1 Other