MAUDE Adverse Event Report: Brainlab SE Navigation SW Cranial EM (Version 1.1); Image Guided Surgery System/Instrument, Stereotaxic, Product Code: HAW

Model Number	22240-06H
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial shunt revision procedure for csf drainage , has been performed with the aid of the brainlab navigation sw cranial em 1.1.After three navigated catheter placement attempts, without retrieving the expected csf, the surgeon determined that these had missed the lateral ventricle and had deviated from the intended path.The surgeon then performed a re-registration and continued the procedure successfully with navigation.According to the surgeon/treating clinician: the procedure was completed successfully as intended with navigation.There was no serious/critical harm or negative clinical effect to the patient due to the deviating catheter placement attempts.Nevertheless for successful outcome of the surgery csf instillation was performed to restore adequate catheter flow.There was no reported serious/critical harm or negative clinical effect due to the prolonged surgery/anesthesia of ca.2.5 hours.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 shunt 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 procedure was completed successfully as intended with navigation.There was no serious/critical harm or negative clinical effect to the patient due to the deviating catheter placement attempts.Nevertheless for successful outcome of the surgery csf instillation was performed to restore adequate catheter flow.There was no reported serious/critical harm or negative clinical effect due to the prolonged surgery/anesthesia of ca.2.5 hours.There were further no remedial actions necessary, done or planned for this patient.There was also no prolongation of hospitalization.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report upon completion of the investigation.H6, h7.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

• Brand Name: Navigation SW Cranial EM (Version 1.1)
• Common Device Name: Image Guided Surgery System/Instrument, Stereotaxic, Product Code: HAW
• 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: boutaina mediane ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 50716681
• Report Number: 8043933-2026-00071
• Device Sequence Number: 9852933
• Product Code: HAW
• UDI-Device Identifier: 04056481132422
• UDI-Public: 04056481132422
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K223288
• Number of Events Summarized: 1
• Summary Report (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): 09/10/2026

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: 22240-06H
• Device Catalogue Number: 71211A
• Device Lot Number: SW v 1.1
• 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: 08/11/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown