MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1); IMAGE GUIDED SURGERY SYSTEM/STEREOT.

Model Number 22214C

Device Problems Use of Device Problem (1670); Misassembly by Users (3133)

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

Event Date 09/19/2014

Event Type  No Answer Provided  

Event Description

A cranial biopsy to retrieve tumor tissue samples was performed with the aid of the brainlab cranial navigation system.The tumor had an approximate diameter of 2.2 cm and was located ca 6cm deep in the brain.During the procedure the surgeon: registered the actual pt anatomy to the navigation (to te ct scan imported into and used by the navigation system), verified and accepted the registration with the non-sterile reference array.Intra-operatively planned a trajectory with the navigation.Draped the pt and exchanged the non-sterile reference array with the sterile reference array.Performed several passes with the biopsy needle, without retrieving tissue samples, but only csf (indicating the target reached to be incorrect).Realized that the reference array was not properly fixated, re-seated the array, re-checked the navigation accuracy and determined accuracy to be now appropriate.Then passed the biopsy needle to the correct target and obtained viable pathological samples as desired.According to the surgeon: the biopsy/surgery was completed successfully as intended with use of the brainlab navigation.There was no unintended tissue resected.There have been no negative clinical effects for this pt due to this issue.

Manufacturer Narrative

A risk to the pt's health could not be excluded for these specific circumstances, since biopsy paths different than planned were applied in the pt's brain, with the brainlab device involved, although: there is no indication of a systematic error or malfunction of the brainlab device regarding this issue, the brainlab device works as intended.Corresponding brainlab measures to minimize this already anticipated risk as low as reasonably practicable are in place.According to the surgeon, the biopsy/surgery was completed successfully as intended with use of the brainlab navigation and there have been no negative clinical effects for this pt due to this issue.According to the results of brainlab investigation and the info provided by the hospital, it can be concluded that the root cause for the difference between the unintended biopsy paths applied and the planned trajectory/intended needle position virtually displayed by the navigation is not correctly seated and/or insufficiently fixated sterile reference array after draping of the pt.Additionally, the user apparently did not recognize the deviation before the unsuccessful passes with the required (regular) accuracy verification of the navigation with the functions available in the navigation sw.There is no indication of a systematic error or malfunction of the brainlab device regarding this issue, the brainlab device works as intended and corresponding brainlab measures to minimize this already anticipated risk as low as reasonably practicable are in place.Brainlab intends to re-iterate the according requirements for navigation accuracy to this hospital, especially the rigid fixation of the reference array, and the required accuracy verification of the navigation after draping of pt and regularly throughout the surgery.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/STEREOT.
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 8562 2; GM 85622
• Manufacturer Contact: markus hofmann ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 4199248
• MDR Text Key: 18089688
• Report Number: 8043933-2014-00037
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22214C
• Device Catalogue Number: 71093A
• Device Lot Number: SW V.2.1.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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