MAUDE Adverse Event Report: BRAINLAB SE CRANIAL NAVIGATION (VESION 4.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	26615-03
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery for a biopsy of a cerebellar lesion has been performed with the aid of the brainlab software cranial navigation 4.1.6 needle passes (and samples) were originally intended, and taken, for this case.One day after the surgery, results from pathology showed the samples taken to be non-diagnostic, and a ct scan revealed a deviation of the actual biopsy path from the planned trajectory.According to the surgeon (treating clinician): a post-operative ct scan showed that the biopsy had been performed at a location that was ca.3-5 mm medial to the tumor.There was no actual harm or negative clinical effect on the patient due to the deviating biopsy path in the original surgery.There was no prolongation of the original surgery/anesthesia (the deviation was detected afterwards).A successful revision biopsy surgery was performed two days after the initial surgery.There was no harm or negative clinical effect on the patient due to the ca.3-hour repeated surgery/anesthesia for the biopsy revision.
Additional Manufacturer Narrative
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 in the brain than anticipated and planned with the brainlab navigation involved, although according to the surgeon (treating clinician): a post-operative ct scan showed that the biopsy had been performed at a location that was ca.3-5 mm medial to the tumor.There was no actual harm or negative clinical effect on the patient due to the deviating biopsy path in the original surgery.There was no prolongation of the original surgery/anesthesia (the deviation was detected afterwards).A successful revision biopsy surgery was performed two days after the initial surgery.There was no harm or negative clinical effect on the patient due to the ca.3-hour repeated surgery/anesthesia for the biopsy revision.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 biopsy needle, placed with aid of navigation, deviating from its intended entry and target points is: an insufficient distribution of surface registration points acquired by the user for the patient anatomy registration to navigation, not following brainlab requirements.The provided data from this surgery shows that registration points were acquired with the softouch on rounded, unspecific areas such as the forehead and left side of head.The points were also not sufficiently distributed on the required distinctive (bony) surfaces, i.E.On both sides of the patient's nose, fully on back of head, right side of head and face.The surgeon commented too that the skin of the patient was mobile, and the patient was positioned in a different way during the procedure (lateral) as opposed to the pre-operative scan (supine) leading to shifting of the skin on which registration points were collected.These caused the navigation software to not find an as accurate as desired match, for this specific procedure, between the pre-operative image dataset and the actual patient anatomy, in the region of interest.Apparently, the resulting deviation of the instrument locations display by the navigation compared to their positions on and in the actual patient anatomy, was not entirely recognized by the user with the necessary navigation accuracy verification of the registration, and continuously throughout the procedure.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 (VESION 4.1)
• 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: kilonzo ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 24379067
• Report Number: 8043933-2026-00008
• Device Sequence Number: 16022190
• Product Code: HAW
• UDI-Device Identifier: 04056481143848
• UDI-Public: 04056481143848
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K223288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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: 26615-03
• Device Catalogue Number: 26674B
• Device Lot Number: SW V. 4.1.0
• 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: 01/22/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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