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

Model Number 22216

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 07/18/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a biopsy (needle) path was applied in a different location in the brain than intended (without biopsy sample actually resected) with the brainlab device involved, despite according to the surgeon: 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 at the original surgery.A revision biopsy surgery was scheduled and performed for this patient.This revision surgery was completed successfully, with diagnostic lesion sample retrieved as desired.There are no further remedial actions necessary, done or planned for this patient due to this issue.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 path different than intended with the navigation, is a combination of the following hardware issues due to use handling (long term and/or rough handling) at this specific site: shift of the navigation reference array during surgery due to defect locking mechanism.Different geometry due to a bent marker pin of the unsterile reference array, compared to the geometry of the sterile array.Threaded screw on the needle guide, allowing movement on the guide's reference array.Further contributing factors were not ideal registration points acquired by user, marker spheres on unsterile equipment not unused, and positioning and movements of the navigation camera during surgery.Apparently the resulting shift between virtually displayed navigation information and the actual patient anatomy was not detected during the required accuracy verification to be performed by the user, before applying the burr hole and inserting the needle (without taking biopsy sample).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.Corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.The damaged hardware components were taken out of action at this site.

Event Description

A cranial surgery for a biopsy (for retrieval of a diagnostic sample) of a lesion located ca.40mm deep in the brain, with a size of ca.30mm, has been performed with the aid of the virtual display of the brainlab navigation.A pre-operative ct was acquired the same day before the surgery, to use with navigation.A trajectory for the biopsy was pre-operatively planned on that ct.During the procedure the surgeon: positioned the patient in a lateral orientation.Performed the initial patient registration on the pre-op ct to match the virtual display of the navigation to the current patient anatomy.The user deemed result acceptable.Draped the patient, exchanged the un-sterile navigation reference array with a sterile array, re-checked accuracy.Compared the position of the biopsy needle with a formerly applied mark on the skin, and considered the needle to be higher than the skin mark.Created a burr hole and placed a navigated biopsy needle with the aid of brainlab navigation and the preplanned target point.Did not take any biopsy sample, but compared the display of the navigation with the sterile pointer at the burr hole, and determined a deviation of ca.20mm.Attempted to re-register the patient to the pre-op ct, but could not achieve an acceptable match with the draped patient anatomy.Decided to abandon the biopsy and shift to another date.A revision biopsy surgery was scheduled and performed for this patient.This revision surgery was completed successfully, with diagnostic lesion sample retrieved as desired.According to the surgeon: 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 at the original surgery.There are no further remedial actions necessary, done or planned for this patient due to this issue.

• 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: 5845925
• MDR Text Key: 51225880
• Report Number: 8043933-2016-00030
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• 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
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2014
• 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