MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216A

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

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

Event Date 01/13/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a laser fiber was placed in the brain in another location than intended with the brainlab device involved, despite according to the surgeon: no laser ablation of unintended (brain) tissue occurred.There were no negative effects to the patient, and there was no delay of the surgery due to this issue.There were no further actions done for this patient during the surgery due to this issue.There are no further remedial actions necessary, done of planned for this patient other than a routine 1 month mri follow-up.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 trajectory/laser fiber placed in another location than intended with the aid of navigation, is that the patients anatomy (skin surface) was different in the pre-op mri used for registration to navigation compared to the actual skin surface at the surgery.This was due to the patient positioning at the surgery causing the skin of the face to move and change.The pre-op mri showing motion artefacts and not being appropriate for surface registration to the brainlab navigation.A further contributing factor is brain shift, with the brain anatomy being different in the ca.1.5 months old pre-op mri, compared to the brain anatomy during the laser fiber placement.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.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial tumor laser ablation was performed with the aid of brainlab cranial navigation system 3.1, for a lesion (melanoma metastasis) with a size of ca.3.5x2.5cm, located in deep right occipital lobe.A pre-operative mri dataset was obtained for use at the surgery and with the aid of the navigation ca.1.5 months before the surgery.A trajectory was planned on the pre-op mri with the brainlab iplan planning software before the surgery.During the procedure the surgeon: positioned the patient in a lateral position with right side up in a (non-brainlab) head holder.Performed the initial patient registration (using surface matching with a combination of z-touch and softouch) to match the virtual display of preoperative mri scan to the current patient anatomy and verified the accuracy of registration with a satisfying result.Aligned the brainlab varioguide with the aid of navigation to the intended trajectory, made the burrhole into the patient's skull, and inserted the probe.Performed an intra-operative mri after placement of probe before ablation, and determined that the actual entry point of the probe's trajectory was ca.9mm medial to planned entry point, the actual target point ca.3mm medial to planned target.Decided to continue with the surgery (laser ablation) with the current placement of the laser probe.Performed the laser ablation of the lesion, with some of the area of enhancement not treatable with the actual laser position.According to the surgeon: no laser ablation of unintended (brain) tissue occurred.There were no negative effects to the patient, and there was no delay of the surgery due to this issue.There were no further actions done for this patient during the surgery due to this issue.There are no further remedial actions necessary, done of planned for this patient other than a routine 1 month mri follow-up.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829 ; 89 9915680
• MDR Report Key: 6331367
• MDR Text Key: 67443050
• Report Number: 8043933-2017-00003
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216A
• Device Catalogue Number: 71205
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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