MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION 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	Speech Disorder (4415)
Date of Event	02/04/2025
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 brain tissue was dissected/resected in a different location than intended with the brainlab navigation involved, and the patient developed a speech problem ("trouble finding words") due to the deviating surgical actions performed in the brain, although according to the surgeon (treating clinician): - the deviation of the actual tumor resection path in the brain from the intended trajectory was detected by the surgeon visually during the surgery, and the surgery was continued successfully without changes of the skull opening and with the use of navigation.- the outcome of this surgery was successful as planned/intended with the removal of the tumor at the end of the surgery.- there was no further harm or negative effect to the patient due to deviating navigated actions, also not due to the prolongation of the surgery/anesthesia of ca.90min.- there were no further medical/surgical remedial actions reported to be 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 dissection/resection pathway performed with the aid of navigation in the skull and brain, deviating by ca.10mm at the skull (entry point) and multiple mm at the target from planned/intended, is: - a not adequate distribution and collection method of surface registration points acquired by the user for the patient anatomy registration to navigation, not following brainlab requirements.Navigation data provided by the hospital for this surgery shows that registration points were not sufficiently distributed on the required distinctive (bony) surfaces, i.E.Not adequately on both sides of the patient's face (but left side only), not in the region of interest at the back of the patients head, and collected in areas of skin shift and artifact/scatter of the pre-operative scan, which shall be avoided.This 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.Apparently, despite a deviation of the navigation accuracy was detected by the user at registration verification, the full extent of the resulting deviation between the actual patient anatomy location during the surgery and the pre-operative scan displayed by the navigation for instrument position visualization during the resection was not recognized by the user with the necessary verification of the navigation accuracy of the registration, and throughout the procedure, including after draping/reference array exchange, before and during performing 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.
Event or Problem Description
A cranial surgery to resect a tumor in the brain was performed with the aid of the display of brainlab software cranial navigation 4.1.During the procedure, brain tissue was dissected/resected in a different location than intended with the brainlab navigation involved.When visibly not reaching the tumor as expected, the surgeons decided to interrupt the surgery and to perform a ct scan for the patient.The same tumor resection surgery was completed successfully as intended with navigation, using the ct scan performed at this surgery.According to the surgeon (treating clinician): - the deviation of the actual tumor resection path in the brain from the intended trajectory was detected by the surgeon visually during the surgery, and the surgery was continued successfully without changes of the skull opening and with the use of navigation.- the outcome of this surgery was successful as planned/intended with the removal of the tumor at the end of the surgery.- the patient developed a speech problem ("trouble finding words") due to the deviating surgical actions performed in the brain with the aid of navigation.- there was no further harm or negative effect to the patient due to deviating navigated actions, also not due to the prolongation of the surgery/anesthesia of ca.90min.- there were no further medical/surgical remedial actions reported to be necessary, done or planned for this patient.Hospitalization of the patient was not prolonged either.

• Brand Name: CRANIAL NAVIGATION 4.1
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 21545011
• Report Number: 8043933-2025-00017
• Device Sequence Number: 7099399
• Product Code: HAW
• UDI-Device Identifier: 04056481143848
• UDI-Public: 04056481143848
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/07/2025

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: 26615-03
• Device Catalogue Number: 26650C
• 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: 02/06/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: Disability; Other
• Patient Sex: Unknown