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 12/16/2022

Event Type  Injury  

Event Description

A cranial surgery to perform a metastasis resection and histopathological verification of a superficial lesion in the frontal lobe, was performed with the aid of the display by the brainlab navigation software cranial 3.5.A pre-operative mri was acquired one day 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 and verified the accuracy of the registration: there was a 2mm deviation detected, but this was within the surgeon's clinical expectations for this procedure, and accepted the registration 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 determined there was no change in the accuracy, and it was still within the surgeon's clinical expectations for this procedure.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 began dissection to the lesion, using the aid of the display of navigation to dissect the tissue.Determined there was a deviation in the display of navigation compared to the actual anatomy, when the lesion was not in the location indicated by the display of navigation: the deviation was 1.5cm in the basal and frontal directions.Enlarged the opening of the dura (by an unspecified amount) and completed the surgery using conventional methods, without further use of navigation.According to the surgeon: the outcome of the surgery was successful as intended using conventional methods.Despite there was an increased risk for the temporal lobe which is epileptogenic, there was no actual harm or negative clinical effect for the patient due to the issue, neither due to the prolonged anesthesia of 45 min - 1 hour.The patient was given preventive antiepileptic therapy but other than enlarging the opening of the dura, there were no further medical/surgical remedial actions necessary, done, or planned for this patient.Hospitalization was prolonged by 1 day.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and tissue dissections were applied in a different location in the brain than anticipated, with the brainlab device involved, and the dura opening required enlargement, despite according to the surgeon: the outcome of the surgery was successful as intended using conventional methods despite there was an increased risk for the temporal lobe which is epileptogenic, there was no actual harm or negative clinical effect for the patient due to the issue, neither due to the prolonged anesthesia of 45 min - 1 hour.The patient was given preventive antiepileptic therapy but other than enlarging the opening of the dura, there were no further medical/surgical remedial actions necessary, done, or planned for this patient.Hospitalization was prolonged by 1 day.H6: according to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the reported 1.5 cm deviation during tumor resection is: an insufficient distribution of points acquired by the user for patient anatomy registration to navigation, not following brainlab requirements.Specifically, registration points were not acquired at both sides of the nose, around the region of interest, or at the back of the head per recommendations.Additionally, points were collected in areas of visible skin shift on the preoperative scan.This caused the navigation software to not find an as accurate match as desired in the region of interest for this specific procedure, between the preoperative image dataset and actual patient anatomy.Further contributing factors (to a lesser extent) are: 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.A change in array geometry can cause a deviation with instrument display between the registration and navigation after draping.- 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.Apparently, the resulting deviation in the navigation display was not recognized with the necessary continued user verification of navigation accuracy (after registration, after draping, and throughout the procedure), after craniotomy was performed, and during the tissue resection.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 reiterate the relevant topics regarding the use of the device to this customer.

• 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: 16948659
• MDR Text Key: 315416453
• Report Number: 8043933-2023-00041
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• 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: 04/20/2023
• 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; Hospitalization