MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE CRANIAL (VERSION 3.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 26615-01A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

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

Event Date 04/10/2023

Event Type  Injury  

Event Description

A cranial surgery to remove a tumor (meningioma) in the frontal lobe of the brain was performed with the aid of the display by the brainlab navigation software cranial 3.5.A preoperative mri was acquired 8 days prior to the surgery, for use with navigation.During the procedure the surgeon: positioned the patient supine in a non-brainlab head holder, and attached the navigation reference array to the head holder.Performed the initial patient registration on the preoperative mri acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy: the first attempt was unsuccessful, and the software returned no match found.Performed the registration a second time, which was successful, and the accuracy of the registration was verified and accepted by the surgeon to proceed.Removed the unsterile patient reference array, draped the patient, and attached the sterile patient reference array to the head holder.Verified the accuracy of navigation with the pointer at the region of interest only and deemed it to be very good to proceed.Planned the incision and craniotomy location using the navigated pointer and marked it on the patient's skin.Performed the skin incision and the craniotomy.Opened the dura and detected an inaccuracy in navigation: the navigated pointer was shown in the display of navigation at the tumor, but the actual position of the pointer was 3-4cm medial, and it was determined the craniotomy deviated from the intended location by 2-3cm caudal and posterior.Expanded the craniotomy by 1.5cm anteriorly and medially in order to access the location of the tumor.Completed the surgery using conventional methods, without further use of navigation.According to the surgeon: the deviation of the position of the craniotomy by 2-3cm caudal and posterior was detected by the surgeon during the surgery, after opening the dura and before resecting/dissecting/penetrating any brain tissue.The outcome of the surgery was successful: the craniotomy was enlarged by 1.5cm anteriorly and medially and the surgery was continued without the use of navigation.There was an increased risk of danger to the convexity veins due to the inaccuracy/deviation of the craniotomy position; however, there was no actual harm or negative clinical effect to the patient due to the inaccuracy/deviation of the craniotomy position: the enlargement of the craniotomy was considered as only trivial damage.There was also no harm or negative clinical effect to the patient due to the prolonged anesthesia of 45minutes.There were no further medical/surgical remedial actions necessary, planned, or done for this patient.Hospitalization was not prolonged either.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy was performed in a different location in the brain than anticipated, with the brainlab device involved, and needed to be extended for the surgery to be effective as intended, despite according to the surgeon: the deviation of the position of the craniotomy by 2-3cm caudal and posterior was detected by the surgeon during the surgery with the necessary accuracy verification, after opening the dura and before resecting/dissecting/penetrating any brain tissue.The outcome of the surgery was successful: the craniotomy was enlarged by 1.5cm anteriorly and medially and the surgery was continued without the use of navigation.There was an increased risk of danger to the convexity veins due to the inaccuracy/deviation of the craniotomy position; however, there was no actual harm or negative clinical effect to the patient due to the inaccuracy/deviation of the craniotomy position: the enlargement of the craniotomy was considered as only trivial damage.There was also no harm or negative clinical effect to the patient due to the prolonged anesthesia of 45minutes.There were no further medical/surgical remedial actions necessary, planned, or done for this patient.Hospitalization was not prolonged either.H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the ca.2-3cm deviation of the craniotomy is: movement of the patient's head and/or patient reference array due to a non-rigid fixation and/or inadvertent forces applied (e.G.During the sterile draping process) after patient registration but before marking the region of interest and location of the craniotomy.A movement of the patient's head relative to the reference array or vice versa cannot be compensated by the navigation system and can result in a deviation between the registered patient image and the actual patient.An insufficient distribution of points acquired by the user for the patient anatomy registration to navigation, not following brainlab requirements.Specifically, the points were not distributed on the required distinctive surfaces, i.E.Both sides of the nose, unique bony anatomy, and both sides of the head.Most registration points were acquired on the front of the head around the eye sockets and some were taken in areas prone to skin shift.This insufficient distribution of registration points caused the cranial navigation software 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 the actual patient anatomy.Potential additional contributing factors (to a lesser extent) are as follows: the distance from camera to the patient reference was between 2.0 - 2.5 m, which exceeds brainlab recommendations of 1.2 - 1.8 m.The reuse of reflective marker spheres on the brainlab device that was used to perform the patient registration at this procedure.Reflective marker spheres are single use only; used marker spheres may be damaged, scuffed, or covered with dirt or other matter, which may prevent the navigation camera from recognizing the sphere in its actual location, and thus negatively impact accuracy.New reflective marker spheres are recommended to be used for every case.One of the patient reference arrays used at this specific surgery was found to have a bent marker post when hardware was inspected by brainlab support after the surgery.It is not known when the damage to the instruments occurred, so the potential use of the damaged instrument for this surgery cannot be excluded as a possible factor.The instrument damage on the array likely occurred through improper handling at the user site, which apparently was not detected by the user after the damage occurred.The navigation software relies on the recognition of an exact same position and geometry of the navigation reference array in relation to the patient anatomy as it was during registration to navigation based on the pre-operative scan to the current patient anatomy, throughout the complete use of navigation during a surgery, in order to accurately track navigated instruments.Use of a damaged patient reference array can negatively impact accuracy in the case, with increasing effect corresponding to a larger distance between the reference and the region of interest.Apparently, the resulting deviation of the navigation display 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.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.

• Brand Name: NAVIGATION SOFTWARE CRANIAL (VERSION 3.5)
• 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: maura pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 16895701
• MDR Text Key: 314843636
• Report Number: 8043933-2023-00034
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481140663
• UDI-Public: 04056481140663
• Combination Product (y/n): N
• Reporter Country Code: BU
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26615-01A
• Device Catalogue Number: 26615-01A
• Device Lot Number: SW V.3.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• 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