MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22214C
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy and unsuccessful path in the brain was performed with the brainlab device involved, and a second surgery was required to complete the procedure, despite according to the hospital: the second surgery to complete resection of the tumor was completed successfully as intended.There were no negative clinical effects to this patient, neither due to the surgeries nor the anesthesia.No further remedial actions were necessary, done or planned for this patient.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 discrepancy of the target location displayed by navigation and the patient's observed anatomy is undetermined.Potential contributing factors are: the pre-op mri scan used for the patient registration for navigation did not fulfill the requirements of the brainlab scan protocol, since the scan contained (motion) artefacts and was not allowing a smooth surface reconstruction.Suboptimal patient registration for navigation, that was apparently not detected by the user with the necessary verification of navigation accuracy.Worn or defective pointer or reference arrays used, and/or the (unsterile) marker spheres used on the instruments during registration and (direct) verification of registration were not new/unused as required.The navigation reference array and/or the patient's head in the head holder might have moved during the surgery (e.G.At draping), due to a not sufficient rigid fixation.A 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 bone flap and loss of cerebrospinal fluid, potentially causing a difference in the location of the brain anatomy.Apparently the discrepancy was not recognized during the necessary continued verification of accuracy throughout the procedure.There is no indication of a systematic error or malfunction of the brainlab device (navigation) contributing to this issue at this surgery.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
Event or Problem Description
An open cranial surgery for resection of a tumor with a size of ca.7mm x 9mm, located ca.25mm deep in the right side of the brain, was intended to be performed with the aid of the brainlab cranial navigation system version 2.1.2.A pre-operative mri was acquired the day before the surgery to use with navigation.During the procedure the surgeon: positioned the patient in the supine orientation in a non-brainlab head holder.Performed the initial patient registration on the pre-op mri with registration points taken on the skin of the patient to match the virtual display of the navigation to the current patient anatomy.The registration result showed good precision.Draped the patient, and navigation reference array was exchanged to a sterile array.Verified the accuracy of the registration on the patient's skin with anatomical landmarks to be acceptable for use.Performed the craniotomy.Once the bone flap was off, surgeon used the brainlab 2 sphere pointer for navigation directions, and got down the path in the brain tissue to where the tumor was supposed to be, but then did not see there the tumor on the navigation display.Surgeon saw the tumor on the navigation, but could not identify it in the patient anatomy.According to the hospital, the deviation from the intended target was ca.1cm.At that point, decision was made by the surgeon to not proceed with the surgery, and the patient was closed up.A second surgery was scheduled for the next day (on (b)(6) 2017) for this patient.Also at this surgery the brainlab navigation was used (using a ct scan with the navigation).According to the hospital, this second surgery to complete resection of the tumor was completed successfully as intended, and no issues with the use of the navigation were reported.According to the hospital: the second surgery to complete resection of the tumor was completed successfully as intended.There were no negative clinical effects to this patient, neither due to the surgeries nor the anesthesia.No further remedial actions were necessary, done or planned for this patient.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.2)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 6427293
• Report Number: 8043933-2017-00010
• Device Sequence Number: 36445
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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
• Operator of Device: Physician
• Device Model Number: 22214C
• Device Catalogue Number: 71208
• Device Lot Number: SW V. 2.1.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other