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 Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy apparently was performed not exactly in the intended location, with the brainlab device involved, although: - there is no indication of a systematic error or malfunction of the brainlab device - corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place - according to the hospital, the enlargement of the craniotomy is not considered a significantly increased risk for this surgery/patient, the tumor was resected successfully, there was no delay of surgery, and there were no adverse effects (other than the craniotomy is bigger) for the 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 craniotomy apparently performed not exactly in the intended location (and display of tumor position not matching its actual position) is a combination of the following factors: - the navigation reference array and/or the patient's head in the head holder might have moved during draping of the patient and exchange from unsterile to sterile array, leading to a deviation of position information displayed by the navigation software.The initial patient registration was not verified after draping of the patient, which would have revealed such a movement of the reference array.- inappropriate quality of the mr patient image that was used for navigation (it was not performed according to the brainlab scan protocol and showed skin shift and motion artefacts) as well as registration point acquisition not being performed in the recommended area (points not collected directly on skin), leading to a patient registration that was not as accurate as desired for this specific patient/surgery.This was apparently not recognized during verification of accuracy after initial patient registration.Further contributing factor (in regard to the observed deviation of displayed tumor position from actual tumor position): - brain shift may have occurred due to the surgical steps (craniotomy) performed and may have led to a decreased navigation accuracy.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to: - inform this hospital about the investigation results, - 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 tumor resection (meningioma, size approx.38 mm) was performed with the aid of the brainlab cranial 3.0 navigation software.During the procedures the surgeon: - positioned the patient in supine position, - registered the actual patient anatomy to the navigation (to the pre-operative image imported into and used by the navigation system), - verified and accepted the patient registration in the navigation, - performed the craniotomy with the aid of navigation, - realized (prior to tissue resection) that the tumor is not located where indicated by navigation (deviation of approx.2 cm), - decided to abandon navigation, - enlarged the craniotomy and resected the tumor.According to the hospital, the enlargement of the craniotomy is not considered a significantly increased risk for this surgery/patient, the tumor was resected successfully, there was no delay of surgery, and there were no adverse effects (other than the craniotomy is bigger) for the patient.

• 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: andrea miller ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 6198298
• MDR Text Key: 63087455
• Report Number: 8043933-2016-00043
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216
• Device Catalogue Number: 22216
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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