Model Number S7 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative was unable to replicate the reported issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced.No parts have been received by the manufacturer for evaluation.
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Event Description
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A medtronic representative reported that while outside of procedure, the navigation system became unresponsive when moved to registration task.It was reported that the issue occurred when setting up for a case and site used another navigation system for the subsequent procedure.There was no patient present at the time of the issue.
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Manufacturer Narrative
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The software investigation found that the reported event was related to a software issue.This issue was documented in a software anomaly tracking database.A review of the system logs provided no further information.
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Manufacturer Narrative
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Device code was corrected.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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