MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SYSTEM - NAVIGATION 4.0; IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTACTIC

Model Number 26615-02B

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2022

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy deviated from the desired location, according to the surgeon resulting in an increased risk of venous sinus thrombosis for this patient due to the unintended exposure of the transverse sinus and torcula, with the brainlab device involved, despite according to the surgeon: the deviation of the craniotomy planned with the aid of navigation was detected after the craniotomy before any surgical actions were performed in the brain (such as resection of brain tissue).There was no harm or negative effect to the patient reported to brainlab.There was also no report of any further remedial medical/surgical actions that would have been necessary, done, or planned for this patient.There was neither any report of prolonged hospitalization.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 planned cranial surgery for a posterior fossa tumor resection has been performed with the aid of the brainlab cranial navigation software version 4.0.A pre-operative mri scan that was acquired 3 days before the surgery was used to register the patient anatomy to the navigation.During the procedure the surgeon: positioned the patient in prone position in a non-brainlab head holder, and attached the reference array for navigation to the head holder.Used the softouch for surface matching to acquire skin points on the patient's head to register the current patient anatomy to the navigation.Verified the registration to navigation, and accepted the accuracy to proceed.Planned the incision and the craniotomy (burr hole) location with the navigated pointer.Performed the incision and created the craniotomy in the skull.Determined that the tentorium had been inadvertently traversed.Rechecked landmarks with the navigation and determined a shift of the navigation display of instrument positions relative to the actual patient anatomy.Completed the surgery without the aid of navigation.Scheduled a follow up surgery performed with the aid of a non-brainlab navigation system.According to the surgeon (treating clinician): the deviation of the craniotomy planned with the aid of navigation was detected after the craniotomy before any surgical actions were performed in the brain (such as resection of brain tissue).There was an increased risk of venous sinus thrombosis for this patient due to the unintended exposure of the transverse sinus and torcula.There was no harm or negative effect to the patient reported to brainlab.There was also no report of any further remedial medical/surgical actions that would have been necessary, done, or planned for this patient.There was neither any report of prolonged hospitalization.

Manufacturer Narrative

H6: according to the results of this technical investigation and the limited information provided by the hospital, it can be concluded that the most likely root cause for the reported deviating craniotomy performed with the aid of navigation i.E.Traversed tentorium and 'unnecessary exposure of the transverse sinus and torcula' is: an inadequate patient scan used for registration in combination with the insufficient distribution of points acquired by the user for patient anatomy registration to navigation.Specifically, the points were not equally distributed on both sides of the patient anatomy and no points were taken at unique bony landmarks e.G.Around the eyes, and entire profile of the nose.The scan also contained distortion/artifacts around the patient's eyes which limited the user in taking points in these critical areas in addition to significant skin shift around the ears where registration points were acquired.This caused the cranial navigation software to not find an accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and the actual patient anatomy.Apparently the resulting deviation of the navigation display was not detected by the user before making the incision and performing the craniotomy, with the necessary accuracy verification of navigation after registration and throughout the procedure.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.H7: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

• Brand Name: CRANIAL NAVIGATION SYSTEM - NAVIGATION 4.0
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTACTIC
• 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: julia mehltretter ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 15500516
• MDR Text Key: 300759941
• Report Number: 8043933-2022-00054
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481141356
• UDI-Public: 04056481141356
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K192703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26615-02B
• Device Catalogue Number: 26615-02B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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