Model Number FUSION COMPACT |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/27/2018 |
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.Device manufacturing date is unavailable.A medtronic representative went to site to test the equipment.Representative reported that a computer and computer case were replaced to resolve the issue.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect parts have not been received by the manufacturer for evaluation.
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Event Description
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A site representative reported that while outside of procedure, the navigation system became unresponsive when connected to endoscope during navigation.It was reported that system was working as expected without the video feed.There was no patient present at the time of the issue.
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Manufacturer Narrative
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Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.
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Manufacturer Narrative
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Correction: the computer case for the navigation system was returned to the manufacturer unused, indicating that the component was not replaced.
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Search Alerts/Recalls
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