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); Insufficient Information (3190); Device Handling Problem (3265)

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

Event Date 08/03/2018

Event Type  Injury  

Manufacturer Narrative

Preliminary conclusion: a risk to the patient's health could not be excluded for these specific circumstances, since a biopsy was performed in another location than intended and an open craniotomy was performed with unintended result (no tumor resected), both with the brainlab device involved, although: the hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides revision surgery) that would have been necessary.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 biopsy (initial case) and an open craniotomy (revision surgery) have been performed on (b)(6) 2018 with the aid of the brainlab cranial navigation system 3.1.During the procedure the surgeon: performed the initial patient registration on the pre-operative image scan (to match the display of the navigation to the current patient anatomy) and verified the accuracy of registration with a satisfying result.Took the biopsy with aid of navigation.Performed a post-operative image scan and realized that the biopsy was not taken in the intended location (deviation of approx.1 cm).Decided to perform a revision surgery.Performed an open craniotomy with aid of navigation on (b)(6) 2018.Was not able to remove the lesion in this surgery.The hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides revision surgery) that would have been necessary.Based on the information received, the system has been used for other surgeries/patients since, without any issues.

Event Description

A cranial surgery for biopsy 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 7 mm in diameter, and located about 42 mm from the surface axial and 25 mm coronal in the frontal lobe.A pre-operative mri scan was acquired on (b)(6) 2018 for use with navigation.During the procedure the surgeon: performed the initial patient registration on the pre-operative image scan (to match the display of the navigation to the current patient anatomy) and verified the accuracy of registration with a satisfying result.Removed tissue with aid of navigation (using the frameless biopsy system).Performed a post-operative image scan and realized that the biopsy was not performed in the intended location (deviation of approx.1 cm).Decided to perform a revision surgery (on (b)(6) 2018, using aid of navigation).According to the hospital, the revision surgery was successful (a diagnostic sample was obtained).No negative clinical effects for this specific patient due to this issue were reported, nor any further remedial actions (besides revision surgery) 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 revision surgery was successful (a diagnostic sample was obtained).No negative clinical effects for this specific patient due to this issue were reported, nor any further remedial actions (besides revision surgery) that would have been necessary.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the alleged 1 cm deviation between planned and actual biopsy location is: a less than ideal point acquisition by the user during the patient registration, not completely following the brainlab recommendations as required (e.G.No points on the right side of the face/ nose), which could cause the 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.A movement of the navigation reference array during the procedure (e.G.At or after array exchange and draping) due to a not sufficient rigid fixation, and/ or movement of the patient's head in the non-brainlab head holder during the surgery is also presumed to have happened.Further contributing factors: a shift of the patient's brain may also have occurred in between the preoperative image data used with navigation and the changed anatomical situation during the surgery, e.G.Due to the craniotomy and/ or loss of cerebrospinal fluid.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.

• 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: 7849580
• MDR Text Key: 119328116
• Report Number: 8043933-2018-00028
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• 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: 22216-01A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other