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

Model Number	22216-02D
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since catheter placements were performed in a different location in the brain than anticipated with the brainlab navigation involved, despite according to the surgeon (treating clinician): the surgeon detected the deviation of the catheter placements when not retrieving the expected csf, placed it successfully freehanded at the very same surgery, and the user successfully restored the navigation accuracy for the planned following tumor resection of this surgery.The outcome of the surgery was successful as intended, without any further changes to the planned procedure.There was no (direct or increased) risk of harm to a critical structure due to the deviating catheter placement attempts.There was no resulting harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca.2hrs.There were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.H6: the device evaluation is currently ongoing, and results are pending - despite continued close follow up by the brainlab representative, the necessary clarifications for the device evaluation could only be retrieved from the surgeon very recently.Brainlab intends to issue a follow-up report upon completion of the device evaluation.
Event or Problem Description
A cranial surgery for a catheter placement in the brain, for drainage of cerebrospinal fluid (csf), followed by a brain tumor resection, has been performed with the aid of the brainlab navigation software cranial 3.1.After two navigated catheter placement attempts, without retrieving the expected csf, the surgeon determined that these had missed the ventricle and had deviated from the intended path.The surgeon placed the drainage catheter freehanded instead at this surgery.Afterwards, the user determined that the navigation accuracy had deteriorated.The or team undraped the patient and re-registered the patient anatomy location to the navigation successfully for the planned tumor resection part of this surgery, with the navigation remaining as accurate as desired for the remainder of the surgery.According to the surgeon (treating clinician): the outcome of the surgery was successful as intended, without any further changes to the planned procedure.There was no (direct or increased) risk of harm to a critical structure due to the deviating catheter placement attempts.There was no resulting harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca.2hrs.There were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.
Event or Problem Description
A cranial surgery for a catheter placement in the brain, for drainage of cerebrospinal fluid (csf), followed by a brain tumor resection, has been performed with the aid of the brainlab navigation software cranial 3.1.After two navigated catheter placement attempts, without retrieving the expected csf, the surgeon determined that these had missed the ventricle and had deviated from the intended path.The surgeon placed the drainage catheter freehanded instead at this surgery.Afterwards, the user determined that the navigation accuracy had deteriorated.The or team undraped the patient and re-registered the patient anatomy location to the navigation successfully for the planned tumor resection part of this surgery, with the navigation remaining as accurate as desired for the remainder of the surgery.According to the surgeon (treating clinician): - the outcome of the surgery was successful as intended, without any further changes to the planned procedure.- there was no (direct or increased) risk of harm to a critical structure due to the deviating catheter placement attempts.- there was no resulting harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca.2hrs.- there were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since catheter placement attempts were performed in a different location in the brain than anticipated with the brainlab navigation involved, despite according to the surgeon (treating clinician): - the surgeon detected the deviation of the catheter placements when not retrieving the expected csf, placed it successfully freehanded at the very same surgery, and the user successfully addressed the navigation accuracy for the planned following tumor resection of this surgery.- the outcome of the surgery was successful as intended, without any further changes to the planned procedure.- there was no (direct or increased) risk of harm to a critical structure due to the deviating catheter placement attempts.- there was no resulting harm or negative effect to the patient, also not due to the surgery/anesthesia prolongation of ca.2hrs.- there were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.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 deviating catheter placement attempts in the brain with the aid of navigation, missing the ventricle without yielding the expected/desired csf, is: - a not adequate distribution of surface registration points acquired by the user for the patient anatomy registration to the navigation / to the pre-operative ct scan, not following brainlab requirements as also guided by the brainlab software.The navigation data from this surgery show that the registration points were not sufficiently distributed on the required distinctive (bony) surfaces, i.E.Not sufficiently on both sides of the patient's head, back of the head, and around the region of interest.The points were collected mainly only on rounded, unspecific areas such as the dome of the head, and for the nose only few points on the middle of the bridge instead of including both sides of it.Additionally, points were acquired behind the left ear, an area prone to skin shift, which should be avoided.This caused the navigation software to not find an as accurate match, between the pre-operative image dataset and the actual patient anatomy in the region of interest, as desired for the catheter placement.As a further contributing factor: - the disposable reflective marker spheres were not fully tightened to the posts of the sterile navigation reference array by the user as required.After the deviating attempts the user found the navigation accuracy to have deteriorated upon re-verifying, and noticed the spheres were not fully attached to the sterile array's posts.This caused the navigation to recognize the sterile reference array in a different position relative to the patient's anatomy than the position of the unsterile array used for the anatomy registration to navigation, and thus contributed to further navigation inaccuracy after the array exchange at patient draping.Re-fixating the marker spheres to the navigation array and re-registering the patient anatomy resulted in a registration match and navigation with sufficient accuracy for the second part of the procedure, i.E., cranial tumor resection.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, and throughout the procedure, for e.G.After draping of the patient and before performing significant invasive 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.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 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: 25372040
• Report Number: 8043933-2026-00036
• Device Sequence Number: 9197075
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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: 22216C
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2026
• 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