MAUDE Adverse Event Report: BRAINLAB AG ENT NAVIGATION SYSTEM (VERSION 3.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT

Model Number 22217A

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 06/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Although according to the hospital there are no negative clinical effects for this patient due to this issue, a risk to the patient's health could not be excluded for these specific circumstances, since an unintended cerebrospinal fluid leakage occurred (that needed to be stopped at the same surgery), due to a cut that was performed in a different location than intended, with the brainlab device involved.: a comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

An ent procedure was planned to be performed with the aid of brainlab ent navigation system 2.1.During the procedure the surgeon: - performed the initial patient registration to match the virtual display of preoperative scan to the current patient anatomy and verified the accuracy of registration with a satisfying result.- later, when using navigation in the nasal cavity, recognized that the navigation display differs from the actual anatomical structure.- proceeded with the surgery using the inaccurate navigation as a guide.- inadvertently broke through the skull base at a location the (inaccurate) navigation indicated an ethmoidal air cell, resulting in cerebrospinal fluid leakage.The leakage was patched in the same surgery and according to the hospital there are no negative clinical effects for the patient due to this issue.

Manufacturer Narrative

According to the results of technical investigation and the information provided by the hospital, it can be concluded that the most probable root cause for the detected shift between virtually displayed data and the actual patient anatomy is: - an inaccuracy caused by a suboptimal registration that was not detected during the required accuracy verification to be performed by the user, and/or - an inaccuracy that was introduced after registration e.G.Due to a shift of the reference array.During the procedure the surgeon recognized the inaccuracy (the navigation display differed about 10 mm from the actual anatomical structure) and decided to proceeded with the surgery using the inaccurate navigation as a guide.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to reduce this already anticipated risk to be as low as reasonably practicable are 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 procedure was performed with the aid of brainlab ent navigation system 3.1.

• Brand Name: ENT NAVIGATION SYSTEM (VERSION 3.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: julia mehltretter ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5832845
• MDR Text Key: 50721967
• Report Number: 8043933-2016-00028
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22217A
• Device Catalogue Number: 22217A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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): Required Intervention