A medtronic representative inspected the navigation system onsite and was able to duplicate the reported issue.When the locking ring was not locked tight and the guide stem was moved after locking the trajectory, the biopsy needle would not navigate.The issue was not the camera or navigation system's ability to 'see' the needle.When the representative tightly locked the ring, the biopsy needle was passed into field of view several times with successful navigation visualization.The passive biopsy needle reflected green on the monitor.It was noted that the biopsy needle is only tracked when it is moving along the trajectory of the plan.If the guide stem is moved to where the biopsy needle is not travelling along the trajectory of the plan, the biopsy needle will not be tracked.No parts were returned to the manufacturer for evaluation.
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A medtronic representative reported that while in a cranial biopsy procedure with the navigation system, it was not possible to track the biopsy needle.The biopsy needle was not tracking during a navigus biopsy.The site reset the target and entry of the plan, updated the entry of the plan using the navigus probe, and re-locked the trajectory at least 3 times.The site also tried using another biopsy needle, rebooted the application, re-positioned the camera and was still unable to track the new needle.The site decided to use the suretrak (orange) tracker to track the biopsy needle.There was a reported delay of 45 minutes to the procedure as a result of this issue and no impact on the patient outcome.Pathology confirmed a positive sample was obtained.
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