Model Number S7 |
Device Problems
Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
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Event Description
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A site representative reported that, while in a functional endoscopic sinus surgery (fess), the emitter of the navigation system was intermittently losing functionality.A second emitter was connected to the navigation system with resolution.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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