MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Despite according to the hospital: there were no negative clinical effects to this patient due to this issue at the original surgery.There was also no negative effect to the patient due to anesthesia prolong of ca.1h at the original surgery, nor due to repeat of anesthesia for revision surgery.There are no other remedial actions necessary, done or planned for this patient due to this issue.Diagnostic lesion samples were retrieved as desired.A risk to the patient's health could not be excluded for these specific circumstances, since it appears that one or more biopsy samples were taken in a different location in the brain than intended, with the brainlab device involved.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 location of biopsy different than intended with the navigation, is a combination of the following contributing factors: the pre-operative mri scan was not performed according to the brainlab scan protocol, and contained motion artefacts due to movements of the head, as well as significant skin shift due to an eye-mask worn by the patient during the scan.For the patient registration on the pre-op mri to match the virtual display of the navigation to the current patient anatomy, the registration points acquired were not sufficiently distributed as required by the navigation software.The accuracy of the registration was verified by the user, found less than ideal but considered sufficient, with available applicable features of the navigation not further used to improve the accuracy result.A slight shift of the patient's brain might have occurred in between the pre-operative mri and the anatomical situation during the surgery, e.G.Due to the burr hole and loss of cerebrospinal fluid, potentially causing a difference in the location of the brain anatomy.It cannot be excluded that the patient's head slightly changed the position inside the head fixation during the surgery, thus a change of the relative position of the head to the navigation reference might have contributed to differences of the actual anatomy and navigation display.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 to this customer: that the brainlab scan protocol must be followed for such scans to be used with brainlab navigation, and especially to avoid skin shift caused by appliances to the patient as well as motion artefacts during the scan.The appropriate registration point distribution as required by the navigation.How to improve the accuracy result of the registration with the available applicable features of the navigation, if found necessary by the user at the required verification of registration or the required accuracy verifications throughout the procedure.To always consider possible brain-shift at the surgery in comparison to the image scan used by the navigation.To always ensure and verify a rigid fixation of the patient's head, also in relation to the reference array for navigation.

Event Description

A cranial surgery for a biopsy of a lesion located ca.50mm deep in the brain (occipital-left) with a size of ca.20mm, has been performed with the aid of the virtual display of the brainlab navigation.A pre-operative mri was acquired 2 days before the surgery, to use with navigation.A trajectory for the biopsy was pre-operatively planned on that mri.During the procedure the surgeon: positioned the patient in a lateral orientation.Performed the initial patient registration on the pre-op mri to match the virtual display of the navigation to the current patient anatomy.Several attempts of registration were necessary to obtain a result the user deemed acceptable.Verified the accuracy of the registration on the patient's skin and considered the accuracy achieved less than ideal, but acceptable for use.Draped the patient, re-checked accuracy, created a burr hole and placed a navigated biopsy needle with the aid of brainlab navigation and the preplanned target point.Took a biopsy sample, lesion tissue could not be confirmed at time of surgery.Decided to modify the trajectory with the same entry point but different target point, nd took another biopsy sample with a navigated biopsy needle following the new trajectory.Lesion tissue could not be confirmed for this new sample at time of surgery.Modified the trajectory again (same entry point, different target point), and took a third biopsy sample with correspondingly navigated biopsy needle.Lesion tissue could not be confirmed at the time of the surgery for this third sample either.The biopsy samples seemed macroscopically to be white matter.The navigation accuracy was re-checked by the user on the patient's skin after negative biopsy results.A post-operative ct scan indicated at least one biopsy sample was taken ca.15mm superior to the intended target.A revision biopsy surgery was scheduled and performed on (b)(6) 2015 for this patient, with using the same brainlab navigation equipment, this time using artificial fiducial markers with the pre-operative mri used with navigation.This revision surgery was completed successfully as intended, with diagnostic lesion sample retrieved as desired.According to the hospital: there were no negative clinical effects to this patient due to this issue at the original surgery.There was also no negative effect to the patient due to anesthesia prolong of ca.1h at the original surgery, nor due to repeat of anesthesia for revision surgery.There are no other remedial actions necessary, done or planned for this patient due to this issue.Additionally, according to the hospital, after biopsy samples were examined by pathology, pathologic tissue samples (as intended) were also retrieved at the original surgery, but apparently hospital staff was not aware until after successful revision surgery.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.0)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: markus hofmann ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5369175
• MDR Text Key: 36027685
• Report Number: 8043933-2016-00001
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2015

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
• Device Operator: Physician
• Device Model Number: 22216
• Device Catalogue Number: 71201
• Device Lot Number: SW V. 3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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