MAUDE Adverse Event Report: BRAINLAB AG ASSUMED SUSPECTED: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216-02

Device Problem Use of Device Problem (1670)

Patient Problem Muscle Weakness (1967)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since biopsies were applied in a different location in the brain than anticipated and desired with the brainlab navigation involved, and according to the surgeon's operative report, the patient awoke with a new weakness in the left foot dorsiflexion.As per the patient's counsel, this drop foot is permanent.Brainlab is unable to determine the actual specific brainlab products involved at this surgery ca.17 months ago from the hospital's multiple systems.The suspected device was assumed only reasonably likely by brainlab with brainlab review of the customer systems for reasonably fitting devices/versions available to the hospital back at the time of surgery.Brainlab review after being aware to only have this option to assume by review, with the customer communicating to refrain to provide any further information to brainlab representatives directly, and including confirmation that here are no longer any navigation logs or data available on the hospital's systems of the time of the surgery that could relate to this surgery and the corresponding actual device used, was completed (b)(6) 2021.As per the surgeon's operative report, the surgeon/users inspected the brainlab images during the procedure and identified a discrepancy between the t1 images and flair images due to inaccurate merge of the data sets.The users therefore re-merged the images until there was a complete overlap of important anatomic landmarks such as the ventricles.According to the results of the brainlab investigation and very limited product-specific/technical information (e.G.No navigation logs or data are available, and being unable to determine the actual specific brainlab products involved at this surgery ca.17 months ago from the hospital's multiple systems), and only being able to assess the above statement from the surgeon being interpretable as his own detected cause, e.G.If one image set was used for navigation registration of the patient scan to the actual anatomy and the other fused (merged) image set was used to actively navigate on, could explain a potential discrepancy of instrument locations in the navigation display.An insufficient image fusion result between the mri t1 images and the flair images accepted and used for navigation by the user can result in a deviating display of instrument positions in navigation compared to their actual position on the patient's anatomy.Apparently the insufficient fusion result and the possibly resulting deviation of the navigation display was not detected by the user with the necessary user verification of accuracy of the image fusion prior to accepting it, and with the required continued navigation accuracy verification by the user on the image set used and displayed during navigation, before the biopsy attempts were performed.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.Due to the limited access to or availability of product-specific and technical information, brainlab cannot assess any other potential cause or contributing factors other than the surgeon's own statement indicating the suspected cause that can explain the observed deviation of the placements compared to the navigation display, which was detected and corrected by the user himself during the procedure with the functions available within the brainlab software as per his own report.Therefore, at this current point in time, there is no further information to provide or re-iterate to this user facility.

Event Description

A cranial surgery for a biopsy for retrieval of a diagnostic sample of a right frontal mass, suspected idh mutant glioma, located in the posterior medial right frontal lobe of the brain immediately anterior to the motor strip, with a size of near 2cm, has been performed with the aid of the brainlab cranial navigation, suspected version 3.1.Pre-operative mri t1 and flair scans were acquired and fused to use with navigation.A trajectory was planned.During the procedure the surgeons: positioned the patient in a supine orientation in a non-brainlab head holder, and brought in the navigation system.Performed the image registration, acquiring registration points on the patient's skin surface to match the display of the navigation to the current patient anatomy.Identified the navigation's projection of the lesion onto the scalp, and shaved a small amount of hair in this area.Draped the patient, aligned the navigated varioguide to the planned trajectory, and made a stab incision in the scalp in the area of the trajectory.Lowered a reducing tube through the varioguide, docked it onto the skull, and drilled the burr hole with a handheld drill aligned to the trajectory, and used a bovie type probe to puncture the dura.Lowered a navigated 1.8mm biopsy needle to the desired depth, and upon aspirating, obtained mildly blood-tinged cerebrospinal fluid (csf) suggesting they were in a sulcus.Removed the needle and designed a more posteriorly aimed trajectory.Aligned the varioguide to the new trajectory, and drilled a new burr hole aligned to this new trajectory.The dura was punctured again with a bovie type probe, the biopsy needle was lowered again and again blood-tinged csf was obtained.As per the surgeon's operative report: "at this point we were concerned about the accuracy of our neuronavigation.Upon inspecting the brainlab images, we identified a discrepancy between the t1 images and flair images due to inaccurate merge of the data sets.We therefore moved to merge again the images until there was complete overlap of important anatomic landmarks such as the ventricles." the surgeons then decided to generate a new trajectory that traversed the mass through the middle.Using the same scalp incision, a new burr hole was drilled through the aligned varioguide and another biopsy was performed using the same procedure as above.The obtained tissue was sent for frozen section and permanent pathology.The frozen section was suggestive of cortical tissue with some atypical cells, but no direct evidence of tumor.Therefore the biopsy needle was lowered an additional 4mm along the same trajectory and 2 additional specimens were obtained and sent for permanent pathology.There was no significant bleeding during the procedure.At this point the surgeons were content with the amount of tissue collected, completed the surgery and closed the patient.According to the surgeon's operative report, the patient awoke with a new weakness in the left foot dorsiflexion.As per the patient's counsel, this drop foot is permanent.

• Brand Name: ASSUMED SUSPECTED: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: 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: 11445861
• MDR Text Key: 249704884
• Report Number: 8043933-2021-00016
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-02
• Device Catalogue Number: 22216-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability