BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVIGATION SOFTWARE CRANIAL 3.1

    MDR report key: 23664882 · Received November 27, 2025

    Report

    Report Number
    8043933-2025-00088
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 27, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    HAW
    UDI-DI
    04056481132439
    PMA / PMN Number
    K192703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2, H1: A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE A LASER FIBER WAS PLACED IN A DIFFERENT LOCATION AND PATH IN THE BRAIN THAN ANTICIPATED AND PLANNED WITH THE BRAINLAB NAVIGATION INVOLVED, DESPITE ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF THE LASER FIBER PLACED WAS DETECTED BY THE SURGEON WITH AN MRI BEFORE ADMINISTERING THE THERMAL LASER TREATMENT IN THE BRAIN, THE LASER PLACEMENT WAS CORRECTED AT THE VERY SAME SURGERY WITH A NEW APPROACH AND SKULL BURR HOLE, AND THE LESION WAS ABLATED SUCCESSFULLY AS DESIRED. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE PROLONGATION OF THE SURGERY/ANESTHESIA BY CA. 30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO NOT PROLONGED. H6: ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE OF THE PLACEMENT LOCATION AND PATH IN THE SKULL AND BRAIN, PERFORMED WITH THE AID OF NAVIGATION, DEVIATING SHIFTED BY CA. 8 MM, IS: A PATIENT ANATOMY REGISTRATION TO THE NAVIGATION (SURFACE MATCHING) BY THE USER ACQUIRING SURFACE REGISTRATION POINTS, YIELDING A NOT AS ACCURATE MATCH AS DESIRED BETWEEN THE PRE-OPERATIVE CT SCAN AND THE ACTUAL PATIENT ANATOMY. A TEST BY THE HOSPITAL AND THE BRAINLAB REPRESENTATIVE AT THE END OF THE SURGERY SHOWED A SIGNIFICANT DIFFERENCE COMPARING THE INITIAL SURFACE MATCHING REGISTRATION USED FOR THE DEVIATING PLACEMENT WITH NAVIGATION, AND THE LATER REGISTRATION OF THE INTRA-OPERATIVE MRI SCAN WITH AUTOMATIC IMAGE REGISTRATION TO NAVIGATION USED FOR THE ACCURATE PLACEMENT CORRECTION - DEMONSTRATING THE DEVIATION OF THE INITIAL SURFACE MATCHING REGISTRATION. DESPITE NO LOG FILES FOR THIS SURGERY COULD BE OBTAINED TO SHOW AND EVALUATE THE DISTRIBUTION OF THE SURFACE REGISTRATION POINTS, THE DEVIATING SURFACE MATCHING REGISTRATION HINTS TO A NOT SUFFICIENT DISTRIBUTION OF THE ACQUIRED SURFACE REGISTRATION POINTS BY THE USER, FOR E.G. NOT SUFFICIENTLY IN THE UNIQUE AREAS AS PER THE BRAINLAB INSTRUCTIONS. APPARENTLY, THE RESULTING DEVIATION BETWEEN THE ACTUAL PATIENT ANATOMY LOCATION DURING THE SURGERY AND THE REGISTERED PRE-OPERATIVE PATIENT IMAGE SCAN, DISPLAYED BY THE NAVIGATION FOR INSTRUMENT POSITION VISUALIZATION, WAS NOT RECOGNIZED BY THE USER WITH THE REQUIRED THOROUGH NAVIGATION ACCURACY VERIFICATION OF THE REGISTRATION, NOR WITH THE NECESSARY CONTINUED VERIFICATION OF NAVIGATION ACCURACY THROUGHOUT THE PROCEDURE, FOR E.G. AFTER DRAPING OF THE PATIENT. 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. H7: BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 0

    A CRANIAL SURGERY FOR A LASER INTERSTITIAL THERMAL THERAPY (LITT) FOR AN ABLATION OF A LESION, LOCATED UP TO CA. 20MM DEEP RIGHT PARIETAL IN THE BRAIN, WITH A SIZE OF CA. 3CCM, HAS BEEN PERFORMED WITH THE AID OF THE BRAINLAB NAVIGATION SOFTWARE CRANIAL 3.1. PLACEMENT OF ONE LASER FIBER WAS INTENDED. AFTER PLACING THE LASER FIBER, THE SURGEONS DETECTED FROM A PRE-ABLATION MRI SCAN, THAT THE LASER FIBER PATH AND TARGET POINT WAS DEVIATING SHIFTED BY CA. 8MM ANTERIORLY AND LATERALLY FROM ITS INTENDED/PLANNED LOCATION. THE SURGEONS DECIDED TO REMOVE THE LASER FIBER AND TO RE-PLACE IT TO A NEW APPROACH WITH A NEW SKULL BURR HOLE AT THE SAME SURGERY, WITH NAVIGATION, RESULTING IN A SUCCESSFUL LASER ABLATION OF THE LESION AS DESIRED. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING PLACEMENTS, ALSO NOT DUE TO THE PROLONGATION OF THE SURGERY/ANESTHESIA BY CA. 30MIN. THERE WERE FURTHER NO REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION WAS ALSO NOT PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2745779 NAVIGATION SOFTWARE CRANIAL 3.1 IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC HAW BRAINLAB SE 22216-02D SW V. 3.1.6 04056481132439

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other