No patient information provided as no patient was involved in this concern.The initial report occurred on (b)(6) 2016 and was found to be a non-reportable malfunction based on the information available at the time the event occurred.On 01/17/2017, a retrospective review related to a capa was completed for all events where the reported malfunction was not previously associated with serious injuries; the reporting determination has been revised to consider these malfunction events reportable.A medtronic representative tested the equipment resulting in the decision to replace the surgeon monitor.After replacing the part, the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
|