BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRANIAL/ENT (VERSION 3.1)

    MDR report key: 23269377 · Received October 10, 2025

    Report

    Report Number
    8043933-2025-00071
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 10, 2025
    Manufacturer
    BRAINLAB SE
    Product Code
    HAW
    PMA / PMN Number
    K192703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 BIOPSY WAS PERFORMED IN A DIFFERENT LOCATION AND PATH IN THE BRAIN THAN ANTICIPATED AND PLANNED WITH THE BRAINLAB NAVIGATION INVOLVED, ALTHOUGH ACCORDING TO THE SURGEON (TREATING CLINICIAN): AFTER THE INACCURACY WAS DETECTED, THE PROCEDURE CONTINUED WITHOUT NAVIGATION, AND THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARMING A CRITICAL STRUCTURE DUE TO THE UNINTENDED SURGICAL STEPS PERFORMED WITH THE AID OF NAVIGATION. THERE WAS NO HARM OR NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE UNINTENDED SURGICAL STEPS PERFORMED WITH THE AID OF NAVIGATION, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 90 MINUTES. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION 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 MOST LIKELY ROOT CAUSE OF THE DEVIATING BIOPSY PERFORMED WITH THE AID OF NAVIGATION, SHIFTED (ANTERIORLY AND MEDIALLY) FROM THE INTENDED TRAJECTORY BY CA. 10 MM IS: A MOVEMENT OF THE NAVIGATION REFERENCE ARRAY DURING THE SURGERY DUE TO INADVERTENT FORCES APPLIED ON IT, AFTER THE PATIENT REGISTRATION TO NAVIGATION. A RELATIVE SHIFT BETWEEN THE REFERENCE ARRAY AND THE PATIENT'S HEAD EXPLAINS THE PARALLEL SHIFT DEVIATION OF THE ACTUAL BIOPSY PATH FROM THE INTENDED TRAJECTORY OBSERVED IN THE IMAGING DATA PROVIDED FOR THIS SURGERY. THERE IS NO INDICATION THAT A MOVEMENT OF THE PATIENT'S HEAD IN THE HEAD HOLDER OCCURRED AT THIS SURGERY. ADDITIONALLY, ACCORDING TO INFORMATION PROVIDED BY THE USER, THE REFERENCE ARRAY WAS SUSPECTED TO HAVE BEEN INADVERTENTLY MOVED DURING THIS PROCEDURE. 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 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 VERIFICATION OF THE NAVIGATION ACCURACY THROUGHOUT THE SURGERY, E.G., AFTER FORCES HAVE BEEN APPLIED, AND BEFORE APPLYING SIGNIFICANT INVASIVE SURGICAL ACTIONS. 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 BIOPSY OF A CA 30 MM3 MASS IN THE LEFT THALAMUS - FOLLOWED BY LASER ABLATION OF THE MASS USING INTRAOPERATIVE MAGNETIC RESONANCE IMAGING SYSTEM (IMRIS)- WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE CRANIAL/ENT 3.1 (USED WITH VARIOGUIDE 1.0). 1 NEEDLE PASS WITH COLLECTION OF 4 SAMPLES WAS ORIGINALLY INTENDED, AND A TRAJECTORY WAS PLANNED BEFORE THE SURGERY USING A PRE-OPERATIVE MR T1 SCAN OF THE PATIENT ACQUIRED 2 DAYS BEFORE THE SURGERY. FROM AN INTRAOPERATIVE MRI SCAN, THE SURGEON DETECTED THAT THE NAVIGATED BIOPSY WAS PERFORMED IN A DIFFERENT LOCATION THAN INTENDED, SHIFTED (PARALLEL) BY CA. 10 MM ANTERIORLY AND MEDIALLY FROM THE PLANNED TRAJECTORY. ACCORDING TO THE SURGEON (TREATING CLINICIAN): AFTER THE INACCURACY WAS DETECTED, THE PROCEDURE CONTINUED WITHOUT NAVIGATION, AND THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. THERE WAS NO DIRECT (OR INCREASED) RISK OF HARMING A CRITICAL STRUCTURE DUE TO THE UNINTENDED SURGICAL STEPS PERFORMED WITH THE AID OF NAVIGATION. THERE WAS NO HARM OR NEGATIVE CLINICAL EFFECT ON THE PATIENT DUE TO THE UNINTENDED SURGICAL STEPS PERFORMED WITH THE AID OF NAVIGATION, ALSO NOT DUE TO SURGERY/ANESTHESIA PROLONGATION OF CA. 90 MINUTES. THERE WERE NO FURTHER REMEDIAL ACTIONS FOR THE PATIENT DONE, NECESSARY OR PLANNED. HOSPITALIZATION WAS NOT PROLONGED EITHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487547 CRANIAL/ENT (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC HAW BRAINLAB SE 22216-02D SW V. 3.1.6

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other