MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SW CRANIAL EM (VERSION 1.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

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	08/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery, for the placement of a shunt in the brain, was performed with the aid of the brainlab navigation software cranial em, version 1.1.According to the surgeon (treating clinician): - a post operative scan revealed that the shunt, placed with the aid of navigation, deviated from its intended target in the brain.- there was neither harm nor negative clinical effect to the patient due to the deviated shunt placement.Clinically, the patient is in good condition and under observation.There were no remedial actions reported to be done, necessary or planned for this patient as a result of the deviation.With the currently available information, the contribution of a brainlab device to the unintended shunt placement can neither be confirmed nor disproven.Further details of the procedure and effects on the patient could not yet be retrieved from the hospital, brainlab continues to follow up with the user facility.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a shunt was placed in the patient's brain in a different position than intended with navigation involved, although according to the surgeon (treating clinician): - there was neither harm nor negative clinical effect to the patient due to the deviated shunt placement.Clinically, the patient is in good condition and under observation.- there were no remedial actions reported to be done, necessary or planned for this patient as a result of the deviation.With the currently available information, the contribution of a brainlab device to the unintended shunt placement can neither be confirmed nor disproven.H6: the device evaluation is currently pending necessary clarifications of the surgical procedure and provision of full access to the navigation system (including data and log files of the surgery).Brainlab continues to follow up with the user facility and intends to issue a follow-up report upon completion of the device evaluation.
Additional Manufacturer Narrative
B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a shunt was placed in the patient's brain in a different position than desired with brainlab navigation involved, despite according to the surgeon (treating clinician): the deviation of the shunt placed with the aid of navigation was detected with a post-operative scan.Clinically, the patient was in good condition and under observation.Despite continued follow up by brainlab, the hospital has not provided any further information on the patient's clinical outcomes.There was no harm or negative effect to the patient reported.There was no reported change of the surgical procedure from its original plan.There was no prolongation of the surgery / anesthesia reported.No remedial actions for the patient were reported that would have been done, necessary or planned, and no prolongation of hospitalization was reported.H6: according to the results of the brainlab investigation and the very limited information provided by hospital, an actual contribution of the brainlab device (navigation system) to the deviating shunt placement in the patient's brain could neither be confirmed nor disproven.Brainlab is also in no position to further assess or evaluate the brainlab device in regard to this surgery as the hospital has not provided it with the necessary details of the surgical procedure as well as the necessary access to the navigation system (e.G.For the relevant files).This is despite multiple attempts made by brainlab to obtain the information from the hospital.There is no indication of a systematic error or malfunction of the brainlab device.
Event or Problem Description
A cranial surgery, for the placement of a shunt in a patient's brain, was performed with the aid of the brainlab navigation software cranial em, version 1.1.From a post-operative scan, the surgeon determined that the shunt was placed in a different position in the patient's brain than intended.According to the surgeon (treating clinician): the deviation of the shunt placed with the aid of navigation was detected with a post-operative scan.Clinically, the patient was in good condition and under observation.Despite continued follow up by brainlab, the hospital has not provided any further information on the patient's clinical outcomes.There was no harm or negative effect to the patient reported.There was no reported change of the surgical procedure from its original plan.There was no prolongation of the surgery / anesthesia reported.No remedial actions for the patient were reported that would have been done, necessary or planned, and no prolongation of hospitalization was reported.

• Brand Name: NAVIGATION SW CRANIAL EM (VERSION 1.1)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: kilonzo ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 20300117
• Report Number: 8043933-2024-00057
• Device Sequence Number: 21049496
• Product Code: HAW
• UDI-Device Identifier: 04056481132422
• UDI-Public: 04056481132422
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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. 1.1.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: Other
• Patient Sex: Unknown