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 Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since potentially brain tissue was resected in another 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

A biopsy was planned to be performed with the cranial navigation system 3.1 (on (b)(6) 2018).During the procedure the surgeon: performed the initial patient registration to match the virtual display of the preoperative scan to the current patient anatomy.Verified the accuracy of registration with a very good result.Obtained the biopsy, but pathology was not able to give a diagnosis (other than either normal brain or hyperactive cells indicating sample was taken on tumor margin).No negative clinical effects were reported for this patient due to this issue, nor any remedial actions that would have been necessary.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a biopsy was performed in another location in 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, and according brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.According to the hospital, the overall procedure was successful as intended, there was no harm to critical structures nor any other negative clinical effect to the patient due to this issue (also not due to anesthesia extended approximately by one hour), there were no further remedial actions necessary for this patient due to this issue, and this issue has not led to any hospitalization delays.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 approximated 5 mm deviation of the navigation display compared to the actual patient anatomy is: a less than ideal scan (distortion correction not enabled in the scan protocol) apparently used for trajectory planning, which led to a deviation of the planned/intended location of the lesion and trajectory (as seen in the scan and displayed by navigation) from its physical location in the actual patient anatomy.Deviations of this nature cannot be recognized by or seen in the navigation system.Additionally, a less than ideal scan (with variable slice thickness, which is attributed to inadequate scanner settings) used for registration and navigation, that could have also led to a less than ideal registration result.To a lesser extent, a further contributing factor is: no new ndi drms were used for unsterile equipment; this may lead to artifacts caused by reflections when reusing old drms, and especially during registration may cause an inaccuracy.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 re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

A cranial surgery for biopsy (to obtain a diagnostic sample) was planned to be performed with the aid of the brainlab cranial navigation system version 3.1 (on (b)(6) 2018).The tumor dimension was about 2.3 mm in diameter; it was located about 4.4 cm from the surface in the coronal plane and 5.2 cm in the sagittal plane.Registration markers were placed on the patient head, and pre-operative mri scans were acquired on the surgery day, for use with navigation.During the procedure the surgeon: positioned the patient in supine orientation and attached the 4 sphere radiolucent reference array for navigation.Performed the initial patient registration on the pre-operative mri scan (to match the display of the navigation to the current patient anatomy).Verified accuracy of the registration and determined it good for this procedure.Draped the patient and exchanged the unsterile reference array for a sterile one, verified accuracy and confirmed it to be good for this procedure.Attached the frameless biopsy system to the skull clamp.Created a burr hole (15 mm) with aid of navigation (position determined using the pointer).Aligned the frameless biopsy system along a pre-planned trajectory.Took samples using the pre-calibrated disposable biopsy needle.Obtained information from pathology that the sample are normal brain tissue or hyperactive cells (indicating sample was taken on tumor margin and not in the center as intended).Decided to continue to use navigation as an aid until he was able to obtain a diagnostic sample (approx.10 samples were taken in multiple depths, instead of initially planned 4 samples).According to the surgeon, the overall procedure was successful as intended, there was no harm to critical structures nor any other negative clinical effect to the patient due to this issue (also not due to anesthesia extended approximately by one hour), there were no further remedial actions necessary for this patient due to this issue, and this issue has not led to any hospitalization delays.

• 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
• MDR Report Key: 8177886
• MDR Text Key: 130783273
• Report Number: 8043933-2018-00050
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481132439
• UDI-Public: 04056481132439
• Combination Product (y/n): N
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216A
• Device Catalogue Number: 71201A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other