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

Model Number 22216B

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since brain tissue has been resected in another region of the brain than intended with the brainlab navigation 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 tumor was resected fully, the surgery was completed.Successfully, there were no further negative clinical effects to this patient, there were no further remedial actions necessary, done or planned for this 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 observed deviation of the navigation display compared to the actual patient anatomy is a combination of the following factors: a less than ideal point acquisition by the user during the patient registrations, not completely following the brainlab recommendations as required, which may cause the brainlab cranial navigation software to not find a match between the display of the preoperative image dataset and the actual patient anatomy that was as accurate as required at the region of interest for this specific procedure.Usage of a less than ideal mr scan for patient registration, not completely following the brainlab recommendations as required, which may result in decreased accuracy in the region of interest (also if registration has been satisfactorily verified) due to possible distortions in the mr image set.Brainlab navigation reference array may have moved during draping and the exchange from unsterile to sterile array or during the procedure due to a not sufficient rigid fixation.A shift of the patient's brain might have occurred in between the preoperative image data and the anatomical situation during the surgery, e.G.Due to the craniotomy and/ or loss of cerebrospinal fluid.Further contributing factors: a less than ideal camera placement (about 1.85 m away from the patient), not completely following brainlab recommendations as required.Apparently the deviation has not been recognized by the user with the necessary continued verification of accuracy throughout the procedure.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 craniotomy for tumor resection was performed with the aid of the brainlab cranial navigation system version 3.1.1 (on (b)(6) 2018).The tumor dimensions were 25 mm x 17 mm, it was located about 18 mm from the surface, at the border between frontal and parietal lobes.A pre-operative mr scan was acquired 6 days before the surgery, for use with navigation.During the procedure the surgeon: positioned the patient in supine orientation and attached the 4 sphere standard cranial reference array for navigation.Performed the initial patient registration on the pre-operative mr scan (to match the display of the navigation to the current patient anatomy), verified accuracy of the registration and determined it not good enough for this procedure.Repeated patient registration on the same mr scan, verified accuracy of the registration and determined it acceptable for this procedure.Planned craniotomy using aid of navigation.Draped the patient, verified accuracy around the region of interest.Performed craniotomy (5 cm in diameter), removed bone flap and opened dura on the planned position.Determined resection starting point using aid of navigation and began resecting brain tissue where he expected tumor below.Was not able to find tumor in that position (realized inaccuracy in this step).Changed his entry by several mm (did not have to revise bone flap or dura retraction), and did not find tumor either.Changed his entry again (this entry was close to original resection starting point), and found the tumor.Estimated that the deviation of navigation display and tumor location was about 4-5 mm.Resected the tumor relying on visual guidance (not relying on navigation).Ended the surgery (with 30 min delay).According to the hospital, the tumor was resected fully, the surgery was completed successfully, there were no further negative clinical effects to this patient, there were no further remedial actions necessary, done or planned for this patient.

• 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: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 7640921
• MDR Text Key: 112428979
• Report Number: 8043933-2018-00018
• 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: 05/31/2018

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: Physician
• Device Model Number: 22216B
• Device Catalogue Number: 22216B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• 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