BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)

    MDR report key: 6636449 · Received June 13, 2017

    Report

    Report Number
    8043933-2017-00015
    Event Type
    Malfunction
    Date Received
    June 13, 2017
    Date of Event
    May 15, 2017
    Report Date
    May 18, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    UDI-DI
    04056481000479
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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, THAT NEEDED TO BE EXTENDED BY A MINOR MARGIN FOR THE SURGERY TO BE EFFECTIVE AS INTENDED, DESPITE ACCORDING TO THE HOSPITAL: - THE SAME SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED. - THERE WERE NO NEGATIVE CLINICAL EFFECTS TO THIS PATIENT, NEITHER DUE TO PROLONG OF ANESTHESIA (OF CA. 10MINS). - NO FURTHER REMEDIAL ACTIONS WERE NECESSARY, DONE OR PLANNED FOR THIS PATIENT. - THERE WAS ALSO NO PROLONGED HOSPITALIZATION 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 A COMBINATION OF THE FOLLOWING CONTRIBUTING FACTORS: - ONE OF THE NAVIGATION REFERENCE ARRAYS USED ON SITE WAS FOUND TO HAVE A BENT PIN. - THE ORIGINALLY ACCEPTED NAVIGATION REGISTRATION ACCURACY ACHIEVED WAS JUDGED TO BE LESS THAN OPTIMAL BUT ACCEPTABLE FOR USE FOR THIS CASE BY THE USER. THE ADDITIONAL DIFFERENCE OF THE REFERENCE INTRODUCED BY A BENT PIN WHEN EXCHANGING THE UNSTERILE TO A STERILE NAVIGATION REFERENCE ARRAY CAN CHANGE SUCH ACCURACY OUTSIDE ACCEPTABLE LIMITS FOR THE SURGERY. 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. NOTE: THE DAMAGED REFERENCE ARRAY HAS BEEN REMOVED FROM USE BY THIS SITE.

    Description of Event or Problem · 1

    AN OPEN CRANIAL SURGERY FOR RESECTION OF A TUMOR, WAS INTENDED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION SYSTEM VERSION 3.1.0 A PRE-OPERATIVE MRI WAS ACQUIRED 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 MEDIUM PRECISION. - VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS, AND JUDGED THE ACCURACY ACHIEVED TO BE LESS THAN OPTIMAL BUT ACCEPTABLE FOR USE FOR THIS CASE. - DRAPED THE PATIENT, AND NAVIGATION REFERENCE ARRAY WAS EXCHANGED TO A STERILE ARRAY. - PERFORMED THE CRANIOTOMY WITH AID OF NAVIGATION. - RECOGNIZED BEFORE OPENING THE DURA THAT THE NAVIGATION DISPLAY DEVIATED FROM THE ACTUAL PATIENT SKULL BONE ANATOMY. - DECIDED TO CONTINUE THIS SURGERY WITHOUT FURTHER USE OF THE AID OF NAVIGATION. - EXTENDED THE EXISTING CRANIOTOMY BY A "MINOR MARGIN" TO BETTER ACCESS THE TUMOR. - COMPLETED THE SAME SURGERY SUCCESSFULLY AS INTENDED. ACCORDING TO THE HOSPITAL: - THE SAME SURGERY WAS COMPLETED SUCCESSFULLY AS INTENDED. - THERE WERE NO NEGATIVE CLINICAL EFFECTS TO THIS PATIENT, NEITHER DUE TO PROLONG OF ANESTHESIA (OF CA. 10MINS). - NO FURTHER REMEDIAL ACTIONS WERE NECESSARY, DONE OR PLANNED FOR THIS PATIENT. - THERE WAS ALSO NO PROLONGED HOSPITALIZATION DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418313 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