BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)

    MDR report key: 6927962 · Received October 9, 2017

    Report

    Report Number
    8043933-2017-00028
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    UDI-DI
    04056481000479
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    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 HOSPITAL: - THE SURGERY WAS TO RETRIEVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. - THE BURR HOLE DID NOT NEED TO BE CHANGED OR INCREASED. - THERE WERE NO NEGATIVE EFFECTS TO THE PATIENT, NEITHER DUE TO THE BIOPSIES NOR DUE TO PROLONG OF SURGERY/ANESTHESIA TIME (OF CA. 3 HRS.). - THE SAME SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED; WITH THE DESIRED (DIAGNOSTIC/PATHOLOGICAL) SAMPLE RETRIEVED. - THERE ARE NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION DID NOT NEED TO BE PROLONGED EITHER. 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 BIOPSIES TAKEN IN A LOCATION DIFFERENT THAN ANTICIPATED WITH NAVIGATION INVOLVED, IS THAT THE NAVIGATION REFERENCE ARRAY HAS MOST LIKELY MOVED DURING THE SURGERY. THIS CAN BE ATTRIBUTED TO A WORN ARRAY FIXATION MECHANISM DUE TO LONG-TERM USE, NOT ENSURING A SUFFICIENTLY RIGID FIXATION. AS A FURTHER FACTOR, THE LESS THAN IDEAL PATIENT REGISTRATION TO THE NAVIGATION BY THE USER MIGHT HAVE ADDITIONALLY CONTRIBUTED. APPARENTLY THE RESULTING DEVIATION BETWEEN DISPLAYED NAVIGATION INFORMATION AND THE ACTUAL PATIENT ANATOMY WAS NOT DETECTED WITH THE NECESSARY CONTINUOUS ACCURACY VERIFICATION 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. THE DUE TO LONG-TERM USE WORN ARRAY FIXATION MECHANISM (MANUFACTURED IN 2007) WAS REMOVED FROM CLINICAL USE AT THIS SITE.

    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. 15 MM, LOCATED CA. 50 MM DEEP IN THE BRAIN'S LEFT TEMPORAL LOBE, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION VERSION 3.1. A PRE-OPERATIVE MRI SCAN WAS ACQUIRED 2 WEEKS BEFORE THE SURGERY, TO USE WITH NAVIGATION. A TRAJECTORY WAS PLANNED FOR THE PROCEDURE. 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 VERY GOOD. - REMOVED THE UNSTERILE NAVIGATION REFERENCE ARRAY AND DRAPED THE PATIENT, AND CREATED A BURR HOLE. - ATTACHED A STERILE REFERENCE ARRAY, RE-VERIFIED ACCURACY AND ALIGNED THE NAVIGATED INSTRUMENT GUIDE TO THE PLANNED TRAJECTORY WITH ENTRY POINT. - PERFORMED THE BIOPSY WITH A NAVIGATED BIOPSY NEEDLE ALIGNING TO THE PLANNED TRAJECTORY WITH TARGET IN THE MIDDLE OF THE LESION. 3 BIOPSY PASSES WERE DONE. PATHOLOGY INFORMED THAT THESE SAMPLES ARE NON-DIAGNOSTIC. - UNDRAPED THE PATIENT AND PERFORMED A NEW PATIENT REGISTRATION FOR NAVIGATION WITH THE SAME PROCEDURE AS FOR THE INITIAL REGISTRATION. - REPEATED THE ABOVE SURGERY STEPS USING THE ALREADY EXISTING (UNCHANGED) BURR HOLE, AND PERFORMED ANOTHER BIOPSY PASS WITH A NAVIGATED BIOPSY NEEDLE ALIGNING TO THE SAME PLANNED TRAJECTORY AND TARGET AS BEFORE. THESE SAMPLES WERE DIAGNOSTIC AS DESIRED. - CLOSED THE PATIENT AND CONCLUDED THE SURGERY. A POST-OP SCAN INDICATED THAT THE SAMPLES OF THE INITIAL UNSUCCESSFUL PASSES WERE TAKEN CA. 10 MM AWAY FROM THE PLANNED TARGET, AT THE RIGHT EDGE OF THE LESION. THE LAST SUCCESSFUL PASS WAS AT THE INTENDED LOCATION. ACCORDING TO THE HOSPITAL: - THE SURGERY WAS TO RETRIEVE A DIAGNOSTIC SAMPLE, NOT TO REMOVE OR TREAT THE LESION. - THE BURR HOLE DID NOT NEED TO BE CHANGED OR INCREASED. - THERE WERE NO NEGATIVE EFFECTS TO THE PATIENT, NEITHER DUE TO THE BIOPSIES NOR DUE TO PROLONG OF SURGERY/ANESTHESIA TIME (OF CA. 3 HRS.). - THE SAME SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED; WITH THE DESIRED (DIAGNOSTIC/PATHOLOGICAL) SAMPLE RETRIEVED. - THERE ARE NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION DID NOT NEED TO BE PROLONGED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709917 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