MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SYSTEM 4.0; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW

Model Number 26615-01B

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a burr hole, biopsy path, and bolt placement were performed in a different location in the brain than anticipated and planned with the brainlab navigation involved, despite according to the surgeon: - the deviation of the laser fiber (and biopsy) placed with the aid of navigation was detected by the surgeon with an intra-operative mri before administering the thermal laser treatment in the brain, there was no correction/extension of the burr hole needed nor a correction of the trajectory, only a different laser probe was needed to be used (side-fire instead of diffuse laser).Also, the biopsy was still inside the lesion and the desired (pathological) samples were obtained.- the final outcome of this surgery was successful as intended - despite there was a direct (or increased) risk of harm to a critical structure (blood vessels) - there was no actual harm/negative clinical effect to the patient due to the deviating biopsy and laser fiber placement, also not due to prolonged surgery/anesthesia time of 30 min.- there were no further remedial actions necessary, done or planned for this patient, nor did the patient require prolonged hospitalization h6: according to the results of the technical investigation and the information provided by the hospital, it can be concluded that the most likely root cause of the burr hole, biopsy path, and bolt placement performed with the aid of navigation deviating by ca.2.5-3mm from their intended location (which is within the expectable system accuracy of 3mm) is: - a non-recommended scan (skin shift due to hardware worn during the registration scan specifically at canthi and side of patients face bilaterally and at back of head due to supine position of the patients head during the scan) which allowed for a suboptimal point acquisition.This in combination with point collection outside of recommendations (no points collected toward rear of head or at region of interest) caused the navigation to not find an as accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and actual patient anatomy.In this case, additional points could have been collected toward the rear of the patients head and at the region of interest based on the data received (3d reconstruction), to improve the registration result.Apparently, the resulting deviation between the actual anatomy location during the surgery and the registered pre-operative patient image scan displayed by the navigation was not recognized by the user with the required thorough verification of the registration accuracy, nor with the necessary continued verification of navigation accuracy after draping, and throughout the procedure before applying 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 Description

A cranial surgery for a laser interstitial thermal therapy (litt) for a tumor located right parietal at a depth of approx.42 mm in the brain, has been performed with the aid of the brainlab navigation version 4.0.0 (and the brainlab nav.Sw cranial 3.1.5 with varioguide) (on (b)(6) 2023).Placement of one laser fiber was intended, with a biopsy of the tumor beforehand with the same path.A pre-operative mri scan was acquired two days before the surgery, and a trajectory was planned.During the procedure the surgeon: - positioned the patient in a lateral orientation in a non-brainlab head holder, with the head turned to the patient's left, and attached the reference array for navigation to the head holder - performed the patient registration on the pre-operative mri scan by acquiring surface matching registration points with the softouch registration pointer on the patient head's skin, to match the display of the navigation to the current patient anatomy, verified the registration to navigation, and accepted the accuracy to proceed - located the planned trajectory with the softouch and marked the entry point on the patient's skin, draped the patient, and exchanged the unsterile navigation reference for a sterile one - attached the varioguide and aligned it to the planned trajectory - made the incision through the varioguide using a long thin non-brainlab handle - inserted a non-brainlab drill guide into the varioguide, and created a burr hole (craniotomy) of 4.5 mm by drilling through the drill guide within the varioguide - switched out the drill guide within the varioguide for the brainlab device guide to be used with the navigated brainlab-distributed biopsy needle - inserted the biopsy needle through the device guide, first only till dura to verify burr hole depth (that they reached dura), then further to the target - took biopsy samples (one pass, four samples) - removed the biopsy needle and device guide and placed a non-brainab bolt inserter through the varioguide, and placed a non-brainlab bolt into the burr hole - inserted a non-brainlab dura piercer into the bolt to confirm no bone would be in the way of the laser - measured the distance from the top of the bolt to the target, moved the varioguide out of the way, and inserted a non-brainlab laser fiber following the bolt's trajectory - acquired an intra-operative mri to verify the laser fiber placement, fused this scan to the pre-operative mri, and detected a deviation (burr hole by ca.2.5 mm from planned location, laser fiber was posterior to planned target) - proceeded with the thermal laser treatment, however, using a non-brainlab side-fire laser probe instead of a non-brainlab diffuse laser probe as planned according to the hospital/neurosurgeon: - the deviation of the laser fiber (and biopsy) placed with the aid of navigation was detected by the surgeon with an intra-operative mri before administering the thermal laser treatment in the brain, there was no correction/extension of the burr hole needed nor a correction of the trajectory, only a different laser probe was needed to be used (side-fire instead of diffuse laser).Also, the biopsy was still inside the lesion and the desired (pathological) samples were obtained.- the final outcome of this surgery was successful as intended - despite there was a direct (or increased) risk of harm to a critical structure (blood vessels) - there was no actual harm/negative clinical effect to the patient due to the deviating biopsy and laser fiber placement, also not due to prolonged surgery/anesthesia time of 30 min.- there were no further remedial actions necessary, done or planned for this patient, nor did the patient require prolonged hospitalization.

• Brand Name: CRANIAL NAVIGATION SYSTEM 4.0
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: HAW
• 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: andrea miller ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 18023539
• MDR Text Key: 326792970
• Report Number: 8043933-2023-00071
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481141356
• UDI-Public: 04056481141356
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26615-01B
• Device Catalogue Number: 26650B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other