MAUDE Adverse Event Report: BRAINLAB AG ALIGNMENT SOFTWARE CRANIAL (VERSION 2.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22884-02A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A cranial surgery for a laser interstitial thermal therapy (litt) for an ablation of a tumor, located right occipital ca.36mm deep in the brain and with a size of ca.15mm, has been performed with the aid of the brainlab alignment software cranial 2.0.Placement of one laser fiber was intended, with a biopsy of the tumor beforehand with 4 passes and samples within the same path.After performing the biopsy with unknown outcome - as the surgeon had not reviewed the pathology results yet- and placing the laser fiber, the surgeon detected from a pre-ablation mri scan, that the laser fiber path and target point was deviating from its intended/planned location, shifted by ca.8mm lateral and posterior.Correspondingly, the biopsy path and target had deviated in the same way.The surgeon determined the current laser fiber placement as usable for the litt treatment and, without any changes, continued with the tumor ablation and completed it successfully as intended.According to the surgeon (treating clinician): - the deviation of the laser fiber placed was detected by the surgeon with an mri before administering the thermal laser treatment in the brain.- the outcome of the biopsy is unknown, since the surgeon had not yet reviewed the pathology result.- the tumor was successfully ablated as planned/intended at the very same surgery, without any changes to the laser fiber's initial position.- there was no direct (or increased) risk of harm to a critical structure due to the deviating brain placements at this surgery.- there was no harm or negative effect to the patient due to the deviating placements - there were no changes done to the planned procedure or surgery - and also not due to the surgery/anesthesia prolong of ca.10min.- there were further no remedial actions necessary, done or planned for this patient.There was also no prolong of hospitalization.
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a biopsy and a laser fiber placement, including skull burr hole, were performed in a different location and path in the brain than anticipated and planned with the brainlab navigation involved, despite according to the surgeon (treating clinician): - the deviation of the laser fiber placed was detected by the surgeon with an mri before administering the thermal laser treatment in the brain.- the outcome of the biopsy is unknown, since the surgeon had not yet reviewed the pathology result.- the tumor was successfully ablated as planned/intended at the very same surgery, without any changes to the laser fiber's initial position.- there was no direct (or increased) risk of harm to a critical structure due to the deviating brain placements at this surgery.- there was no harm or negative effect to the patient due to the deviating placements - there were no changes done to the planned procedure or surgery - and also not due to the surgery/anesthesia prolong of ca.10min.- there were further no remedial actions necessary, done or planned for this patient.There was also no prolong of hospitalization.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 placements locations and paths, in the skull and in the brain, performed with the aid of navigation, deviating shifted by ca.8 mm lateral and posterior, is: - a not adequate distribution of surface registration points acquired by the user for the patient anatomy registration to navigation, not following brainlab requirements.The navigation data from this surgery shows that registration points were acquired on areas prone to skin shift, such as around the ear, which shall be avoided.The points were not sufficiently distributed on the required distinctive (bony) surfaces, i.E.Not sufficiently on both sides of the patient's face and not in the region of interest, the back of the head.Navigation data shows points collected mainly on the nose, and none on the left side or the back of the patient's head.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, in the region of interest.Apparently, the resulting deviation between the actual patient anatomy location during the surgery and the registered pre-operative patient image scan displayed by the navigation for instrument position visualization was not recognized by the user with the required thorough navigation accuracy verification of the registration, nor with the necessary continued verification of navigation accuracy after draping, and throughout the procedure 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.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

• Brand Name: ALIGNMENT SOFTWARE CRANIAL (VERSION 2.0)
• 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: 20893770
• Report Number: 8043933-2024-00081
• Device Sequence Number: 20776539
• Product Code: HAW
• UDI-Device Identifier: 04056481144487
• UDI-Public: 04056481144487
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K223864
• 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
• Report Date (Section B): 12/10/2024

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: 22884-02A
• Device Catalogue Number: 22889
• Device Lot Number: SW V. 2.0.1
• 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: 11/13/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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