A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that the reported event was unrelated to a software issue.The investigation found that it is suspected that the site did not follow the instructions for use (ifu) resulting in the reported issue.The software functioned as designed.According to the cranial optical pocket guide page 134 "restart calibration," suretrak can be re-calibrated by clicking "restart calibration." 9735411 rev 4.
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A site representative reported that, when attempting to perform a suretrack calibration on the navigation system, the calibration would not appear.Removing and adding the tool card did not resolve the reported issue.The issue was resolved by restarting the software.No additional information was provided.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.
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