Model Number FUSION |
Device Problems
No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.It was reported that the transformer for the navigation system was replaced the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The transformer 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.
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Event Description
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A site representative reported that, while in a functional endoscopic sinus surgery (fess), the monitor of the navigation system lost display functionality during registration.It was reported that the navigation system was restarted, the previous registration loaded and the site continued with the procedure.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.No additional information was provided.
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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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