BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL NAVIGATION

    MDR report key: 23670774 · Received November 28, 2025

    Report

    Report Number
    8043933-2025-00089
    Event Type
    Injury
    Date Received
    November 28, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 28, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    HAW
    UDI-DI
    04056481143848
    PMA / PMN Number
    K223288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 CATHETER WAS PLACED IN A DIFFERENT LOCATION IN THE BRAIN THAN ANTICIPATED WITH THE BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE DEVIATION OF A CATHETER INCORRECTLY PLACED WITH THE AID OF NAVIGATION WAS DETECTED BY THE SURGEON DURING THE SURGERY (NO CSF CAME OUT OF CATHETER AFTER INSERTION), AND THE SURGEON DECIDED TO REMOVE THE CATHETER AND TO CONTINUE THE PROCEDURE WITHOUT NAVIGATION AND WITHOUT BRAIN RELAXATION DRAINAGE. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS PLANNED/INTENDED WITH THE TUMOR RESECTED AS DESIRED. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO THE DEVIATING BRAIN CATHETER PLACEMENT, ALSO NOT DUE TO THE PROLONGATION OF THE SURGERY/ANESTHESIA OF SOLELY 5 -10 MIN. THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION OF THE PATIENT WAS NOT PROLONGED EITHER. 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 CATHETER PLACED WITH AID OF NAVIGATION DEVIATING AT THE TARGET BY CA. 8MM FROM INTENDED POSITION IN THE BRAIN VENTRICLE, IS: A MOVEMENT OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY DUE TO INADVERTENT FORCES APPLIED ON IT, AFTER THE BURR HOLE CREATION, AND PRIOR TO OR DURING CATHETER PLACEMENT. A RELATIVE SHIFT BETWEEN THE REFERENCE ARRAY AND THE PATIENT'S HEAD EXPLAINS THE PARALLEL SHIFT OF THE NAVIGATION DISPLAY OBSERVED BY THE USER AFTER THE CATHETER PLACEMENT. THERE IS NO INDICATION THAT A MOVEMENT OF THE PATIENT'S HEAD IN THE HEAD HOLDER OCCURRED AT THIS SURGERY, THEREFORE THE PARALLEL SHIFT IN THE NAVIGATION DISPLAY INDICATES THE ARRAY MUST HAVE MOVED. MOVEMENT OF THE REFERENCE ARRAY AFTER PATIENT REGISTRATION TO NAVIGATION DISRUPTS THE COORDINATE SYSTEM ESTABLISHED DURING THE REGISTRATION AND CAUSES A DEVIATION BETWEEN THE DISPLAYED IMAGE SCAN, ON WHICH THE NAVIGATED INSTRUMENTS ARE TRACKED, AND THE ACTUAL PATIENT ANATOMY. THIS MOVEMENT CANNOT BE COMPENSATED FOR BY THE NAVIGATION SOFTWARE. APPARENTLY, THE RESULTING DEVIATION BETWEEN THE ACTUAL PATIENT ANATOMY LOCATION DURING THE SURGERY AND THE REGISTERED PRE-OPERATIVE PATIENT IMAGE SCAN, WAS NOT RECOGNIZED BY THE USER WITH THE REQUIRED CONTINUED VERIFICATION OF NAVIGATION ACCURACY THROUGHOUT THE PROCEDURE, FOR E.G. DIRECTLY BEFORE AND DURING PERFORMING INVASIVE SURGICAL STEPS. 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 RESECTION OF A TUMOR, LOCATED ORBITAL FRONTAL CA. 9 CM DEEP IN THE BRAIN, AND WITH A SIZE OF CA. 0.7CCM, HAS BEEN PLANNED TO BE PERFORMED WITH THE AID OF THE BRAINLAB CRANIAL NAVIGATION 4.1. FOR RELAXATION OF THE BRAIN BEFORE TUMOR RESECTION, A CATHETER WAS PLANNED TO BE PLACED IN THE VENTRICLE WITH THE AID OF BRAINLAB CRANIAL NAVIGATION 4.1. WHEN THE CATHETER WAS PLACED TO THE VENTRICLE WITH THE NAVIGATED DISPOSABLE STYLET INSIDE, NO EXPECTED CRANIOSPINAL FLUID (CSF) WAS PRODUCED. UPON VERIFYING ACCURACY USING THE POINTER AT THE REGION OF INTEREST, THE SURGEON DETERMINED THAT NAVIGATION WAS NO LONGER ACCURATE, AND THE TARGET POINT OF THE CATHETER DEVIATED BY CA. 8 MM. AS THE TUMOR WAS ALREADY EXPOSED, THE SURGEON DECIDED TO REMOVE THE CATHETER AND TO CONTINUE THE PROCEDURE WITHOUT NAVIGATION AND WITHOUT BRAIN RELAXATION DRAINAGE. ACCORDING TO THE SURGEON (TREATING CLINICIAN): THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS PLANNED/INTENDED WITH THE TUMOR RESECTED AS DESIRED. THERE WAS NO HARM OR NEGATIVE EFFECT TO THE PATIENT DUE TO DEVIATING BRAIN CATHETER PLACEMENT, ALSO NOT DUE TO THE PROLONGATION OF THE SURGERY/ANESTHESIA OF SOLELY 5 -10 MIN. THERE WERE NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS NECESSARY, DONE OR PLANNED FOR THIS PATIENT. HOSPITALIZATION OF THE PATIENT WAS NOT PROLONGED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2220050 CRANIAL NAVIGATION IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC HAW BRAINLAB SE 26615-03 SW V. 4.1.0 04056481143848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other