BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)

    MDR report key: 6844306 · Received September 6, 2017

    Report

    Report Number
    8043933-2017-00026
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 8, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    UDI-DI
    04056481000479
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A BIOPSY WAS APPLIED IN A DIFFERENT LOCATION IN THE BRAIN THAN ANTICIPATED WITH THE BRAINLAB DEVICE INVOLVED, DESPITE ACCORDING TO THE SURGEON: - THE SURGERY WAS TO RETRIEVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. - THE SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED, WITH THE DESIRED PATHOLOGICAL SAMPLE FROM THE LESION RETRIEVED AND WITHOUT ANY ISSUES DURING THE SURGERY, I.E. NO CHANGE OF INTENDED SURGERY STEPS NOR DELAY. - IT IS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE NEW NUMBNESS, AND NO MEDICAL ACTIONS WERE NECESSARY FOR THE PATIENT FOR THIS. - THERE WERE NO OTHER NEGATIVE EFFECTS TO THE PATIENT, AND NO REMEDIAL ACTIONS ARE NECESSARY, DONE OR PLANNED FOR THIS PATIENT. 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 BIOPSY TAKEN IN A LOCATION DIFFERENT THAN ANTICIPATED WITH NAVIGATION INVOLVED, IS THAT THE REFERENCE ARRAY FOR NAVIGATION HAS MOST LIKELY MOVED AFTER THE INITIAL PATIENT REGISTRATION. AS A FURTHER CONTRIBUTING FACTOR, A SHIFT OF THE PATIENT'S BRAIN MIGHT HAVE OCCURRED IN BETWEEN THE PRE-OP MRI AND THE ANATOMICAL SITUATION DURING THE SURGERY, E.G. DUE TO THE BONE FLAP AND/ OR LOSS OF CEREBROSPINAL FLUID. APPARENTLY THE RESULTING DEVIATION BETWEEN DISPLAYED NAVIGATION INFORMATION AND THE ACTUAL PATIENT ANATOMY WAS NOT DETECTED DURING THE REQUIRED ACCURACY VERIFICATION TO BE PERFORMED BY THE USER. 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 BIOPSY (FOR RETRIEVAL OF A DIAGNOSTIC SAMPLE) OF A LESION WITH A SIZE OF CA. 4 CM, LOCATED IN THE BRAINSTEM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.1. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED THE SAME DAY OF THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: - POSITIONED THE PATIENT IN A SUPINE ORIENTATION. - PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP MRI WITH SURFACE MATCHING TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. - VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. - REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT. - CREATED A BURR HOLE, AND ATTACHED A STERILE REFERENCE ARRAY - PERFORMED THE BIOPSY WITH A NAVIGATED BIOPSY NEEDLE (ONE PASS). - COMPLETED THE SURGERY SUCCESSFULLY AS INTENDED, WITH THE DESIRED PATHOLOGICAL SAMPLE FROM THE LESION RETRIEVED. AFTER THE SURGERY, THE PATIENT HAD A NEW NUMBNESS ON ONE SIDE OF THE BODY. NO MEDICAL ACTIONS WERE NECESSARY FOR THE PATIENT FOR THIS, AND IT IS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE NUMBNESS. THE SURGEON COMPARED A SCREENSHOT OF THE NAVIGATED PATH TAKEN DURING THE SURGERY TO A POST-OP MRI TAKEN THE NEXT DAY, AND DETERMINED A DEVIATION OF CA. 1 CM BETWEEN THE INTENDED TARGET AND THE ACTUAL BIOPSY APPLIED. ACCORDING TO THE SURGEON: - THE SURGERY WAS TO RETRIEVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. - THE SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED, WITH THE DESIRED PATHOLOGICAL SAMPLE FROM THE LESION RETRIEVED AND WITHOUT ANY ISSUES DURING THE SURGERY, I.E. NO CHANGE OF INTENDED SURGERY STEPS NOR DELAY. - IT IS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE NEW NUMBNESS, AND NO MEDICAL ACTIONS WERE NECESSARY FOR THE PATIENT FOR THIS. - THERE WERE NO OTHER NEGATIVE EFFECTS TO THE PATIENT, AND NO REMEDIAL ACTIONS ARE NECESSARY, DONE OR PLANNED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625425 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