MAUDE Adverse Event Report: BRAINLAB SE CRANIAL NAVIGATION; 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	10/29/2025
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 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.
Event or Problem Description
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.

• Brand Name: CRANIAL NAVIGATION
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB SE; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB SE; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: nina duerr ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 23670774
• Report Number: 8043933-2025-00089
• Device Sequence Number: 9808180
• Product Code: HAW
• UDI-Device Identifier: 04056481143848
• UDI-Public: 04056481143848
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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
• Device Model Number: 26615-03
• Device Catalogue Number: 26615-01C
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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