Model Number S7 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 11/30/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
No patient information provided as no patient was involved in this concern.No procode, common device name, unique device identification (udi) and/or 510k provided as this device is not released for distribution in the united states.No parts have been received by the manufacturer for evaluation.
|
|
Event Description
|
A medtronic representative reported that, while outside of a procedure, the navigation system displayed there was no signal and was unresponsive to prompts from the user.The calibrations for the microscope could not be performed.There was no patient present when this issue was identified.No additional information was provided.
|
|
Manufacturer Narrative
|
A medtronic representative went to the site to test the equipment.It was reported that the computer of the navigation system was replaced to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The computer for the navigation system was returned to the manufacturer for analysis.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.
|
|
Search Alerts/Recalls
|