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

Model Number 22217B

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Cerebrospinal Fluid Leakage (1772); No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since unintentionally the base of the patient's skull was perforated and the dura was cut leading to a csf leak with the brainlab device involved, despite according to the surgeon: the perforation and csf leak was successfully repaired at the very same surgery.The deviation of the navigation display by ca.3 mm was detected by the user before the surgery steps with aid of navigation were performed.There was no (direct or increased) risk to harm any other critical structure due to this issue.The same surgery was completed successfully as intended.There were no further negative clinical effects to this patient, neither due to the repaired csf leak perforation, nor due to prolong of surgery/anesthesia (of ca.1 hour).There were no further remedial actions necessary, done or planned for this patient.As a precaution, the patient was admitted to the hospital for overnight observation.According to the results of the brainlab investigation and the information provided by the customer, it can be concluded that the main root cause for the observed deviation of the navigation display of ca.3 mm contributing to the unintentional perforation, is: an insufficient point acquisition by the user during the patient registration, not following the brainlab recommendations as required.This caused the brainlab ent 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 desired at the region of interest for this specific case.This has been recognized by the user with the necessary continued user verification of accuracy, after the registration and before performing the surgery steps with aid of navigation.Apparently the user considered the accuracy achieved and the detected deviation as clinically acceptable for this surgery.As a further contributing factor, the navigation reference array/headband may have additionally moved during the surgery due to a not sufficiently rigid fixation.There is no indication of a systematic error or malfunction of the brainlab device (navigation).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 functional endoscopic sinus surgery (fess) was performed with the aid of the brainlab ent navigation system version 3.1.The surgical area included anatomy near the skull base.During the procedure the surgeon: positioned the patient in supine orientation and attached the reference headband and reference array for navigation.Performed the initial patient registration on the pre-op ct with registration points taken on the skin of the patient to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration on the patient's skin with anatomical landmarks, and judged the navigation accuracy achieved less than optimal, but acceptable for use for this case.Started the surgery using an endoscope, calibrated (non-brainlab) instruments to the navigation to use navigation once being near critical structures.Noted that the instrument position displayed by navigation did not match the image from the endoscope, and determined that the navigation display deviated by ca.3 mm.Continued the surgery with navigation.When using an sharp-edge instrument calibrated to navigation as a probe, unintentionally the base of the patient's skull was perforated and the dura was cut with the blade of the navigated instrument, leading to a csf leak that was successfully repaired at the same surgery.The surgery continued and was completed successfully as intended.According to the surgeon: the perforation and csf leak was successfully repaired at the very same surgery.The deviation of the navigation display by ca.3 mm was detected by the user before the surgery steps with aid of navigation were performed.There was no (direct or increased) risk to harm any other critical structure due to this issue.The same surgery was completed successfully as intended.There were no further negative clinical effects to this patient, neither due to the repaired csf leak perforation, nor due to prolong of surgery/anesthesia (of ca.1 hour).There were no further remedial actions necessary, done or planned for this patient.As a precaution, the patient was admitted to the hospital for overnight observation.

• Brand Name: ENT NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 7608984
• MDR Text Key: 112154068
• Report Number: 8043933-2018-00017
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000462
• UDI-Public: 04056481000462
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22217B
• Device Catalogue Number: 22217B
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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): Hospitalization; Other