MAUDE Adverse Event Report: BRAINLAB SE NAVIGATION SOFTWARE CRANIAL 3.1; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22216-02D
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: NAVIGATION SOFTWARE CRANIAL 3.1
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB SE; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB SE; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 23664882
• Report Number: 8043933-2025-00088
• Device Sequence Number: 16052806
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 22216-02D
• Device Catalogue Number: 26525A
• Device Lot Number: SW V. 3.1.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown