MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT

Model Number 22214-02D

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

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

Event Date 06/17/2016

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 sample has been taken in another region of the brain than intended with the brainlab device involved, although: 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.There has been no negative clinical effect due to this issue reported to brainlab for this specific patient.According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the detected inaccuracy is a combination of the following: during initial patient registration the navigation software potentially did not find a match between the virtual display of the preoperative image dataset and the actual patient anatomy that was as accurate as desired for this specific surgery, due to the fact that the point acquisition was not performed in the recommended area, only few points taken in the region of interest and skin shift may have occurred during registration.Major change of the camera position relative to the reference array during the procedure, that can potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure.Brain shift that has occurred due to the resection of the cyst and cannot be compensated by the navigation device, since the actual patient anatomy differs from the preoperative image data used for navigation.Apparently the resulting shift between virtually displayed data and the actual patient anatomy was not detected during the required accuracy verification to be performed by the user.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.

Event Description

A cranial surgery for cyst and tumor resection was planned to be performed with the aid of the brainlab cranial navigation system.During the procedure the surgeon: performed the initial patient registration to match the virtual display of preoperative scans to the current patient anatomy and verified the accuracy of registration with a satisfying result.Planned the craniotomy and draped the patient, followed by an additional accuracy verification.Used the aid of navigation to perform the incision and remove the bone flap.Brought a microscope into the field and, due to visibility issues, re-positioned the camera from the patient's feet to the patient's head.Found and removed the cyst.Used the aid of navigation to locate the tumor and took a biopsy.The biopsy revealed normal tissue.Realized that the navigation was approximately 10 mm off.The surgery was continued without the aid of navigation and could be completed successfully.There has been no negative clinical effect due to this issue reported to brainlab for this specific patient.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)
• 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: 5794015
• MDR Text Key: 49523965
• Report Number: 8043933-2016-00022
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2016

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: Health Professional
• Device Model Number: 22214-02D
• Device Catalogue Number: 71207
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2016
• 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