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 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy was performed with the brainlab device involved, that needed to be extended by a minor margin for the surgery to be effective as intended, despite according to the hospital: - the same surgery was completed successfully as intended.- there were no negative clinical effects to this patient, neither due to prolong of anesthesia (of ca.10mins).- no further remedial actions were necessary, done or planned for this patient.- there was also no prolonged hospitalization due to this issue.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 discrepancy of the display by navigation and the patient's observed anatomy is a combination of the following contributing factors: - one of the navigation reference arrays used on site was found to have a bent pin.- the originally accepted navigation registration accuracy achieved was judged to be less than optimal but acceptable for use for this case by the user.The additional difference of the reference introduced by a bent pin when exchanging the unsterile to a sterile navigation reference array can change such accuracy outside acceptable limits for the surgery.Apparently the discrepancy was not recognized before the craniotomy during the necessary continued verification of accuracy throughout the procedure.There is no indication of a systematic error or malfunction of the brainlab device (navigation) contributing to this issue at this surgery.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.Note: the damaged reference array has been removed from use by this site.

Event Description

An open cranial surgery for resection of a tumor, was intended to be performed with the aid of the brainlab cranial navigation system version 3.1.0 a pre-operative mri was acquired before the surgery to use with navigation.During the procedure the surgeon: - positioned the patient in prone orientation in a non-brainlab head holder.- performed the initial patient registration on the pre-op mri with registration points taken on the skin of the patient to match the virtual display of the navigation to the current patient anatomy.The registration result showed medium precision.- verified the accuracy of the registration on the patient's skin with anatomical landmarks, and judged the accuracy achieved to be less than optimal but acceptable for use for this case.- draped the patient, and navigation reference array was exchanged to a sterile array.- performed the craniotomy with aid of navigation.- recognized before opening the dura that the navigation display deviated from the actual patient skull bone anatomy.- decided to continue this surgery without further use of the aid of navigation.- extended the existing craniotomy by a "minor margin" to better access the tumor.- completed the same surgery successfully as intended.According to the hospital: - the same surgery was completed successfully as intended.- there were no negative clinical effects to this patient, neither due to prolong of anesthesia (of ca.10mins).- no further remedial actions were necessary, done or planned for this patient.- there was also no prolonged hospitalization due to this issue.

• 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: 6636449
• MDR Text Key: 77538513
• Report Number: 8043933-2017-00015
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216A
• Device Catalogue Number: 71201A
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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