Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred preoperatively and delayed surgery by less than one hour.It was reported that when the site initially booted their system, the procedure types were missing from the software and the software was slow/unresponsive.The site rebooted the system and then the procedure types were back, and they were able to proceed to registration.The manufacturer representative (mr) booted the system and the procedures were there, but all the patients on the system were missing.The mr worked through the software a few times and then the patients reappeared in the software.The system was rebooted once more, and the issue was resolved.The surgery was completed with navigation and imaging.There was no impact on patient outcome.
|