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

Model Number 22214B

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Device Handling Problem (3265)

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

Event Date 11/26/2018

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 penetrated / harmed (by deviated insertion of nico brainpath) in another location than intended with the brainlab device involved, and therewith could have led to harm of critical structures within the brain, although: according to the surgeon the outcome of the surgery (removal of tumor) was successful as intended, there were no further remedial actions necessary and there are no negative clinical effects expected for this patient due to this issue.Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable 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 cranial surgery for tumor (vascular malformation) resection was performed with the aid of the brainlab cranial navigation system version 2.1.According to the surgeon's planning the tumor had a size of approximately 1.5x1.6x1.3 mm and was located near the brainstem and cerebellum.A pre-operative mri scan for use with brainlab navigation was acquired three days prior to the day of surgery.During the procedure the surgeon: positioned the patient in prone orientation clamped, into a (non-brainlab) head holder, attached with the brainlab navigation reference array.Performed the initial patient registration (surface matching registration with brainlab softouch) to match the virtual display of preoperative mri scan to the current patient anatomy.Verified the accuracy of registration and, after a second registration attempt, determined the registration accuracy as appropriate.Draped the patient and performed incision and burr hole with the aid of navigation.Inserted the nico brainpath device (non-brainlab device) with the aid of navigation and verified its placement.Detected a deviation of about 10 mm inferior between the information provided by the navigation system and the actual patient anatomy.Closed the burr hole, undraped the patient and attempted a new registration, but was unable to perform this due to covered facial structures.Proceeded the surgery with the initial registration by compensating the detected deviation in mind and successfully located the intended target.According to the surgeon the outcome of the surgery (removal of tumor) was successful as intended, there were no further remedial actions necessary and, despite he thinks that the 8th cranial nerve was slightly aggravated due to this issue, there are no negative clinical effects expected for this patient due to this issue.

Manufacturer Narrative

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 alleged deviation of about 10 mm inferior can be attributed to a combination of the following: suboptimal initial patient registration, since the patient's actual anatomy probably differed from the preoperative image data set, due to different patient position.This potentially led to an inaccurate match of the virtual display of preoperative scan to the current patient anatomy during the initial patient registration.Major change of the camera position relative to the 3-marker reference array during the procedure, that can potentially intensify small inaccuracies arising from individual steps of the complex navigation procedure.Transparent draping of the nonsterile reference array (instead of exchanging the reference array from unsterile to sterile), potentially leading to reflections and therewith to an incorrect / shifted recognition of the marker spheres.Apparently the deviation was not recognized by the user surgeon, with the necessary continued verification of accuracy after initial registration and throughout the procedure.There is no indication of a systematic error or malfunction of the brainlab device.This event has been identified by brainlab as "use error".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.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• MDR Report Key: 8177881
• MDR Text Key: 130785753
• Report Number: 8043933-2018-00052
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• 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: 11/30/2018

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: 22214B
• Device Catalogue Number: 71208
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other