Model Number 9735602 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.Udi not available for this system at time of filing.System not evaluated as issue was resolved by reseating and cleaning cable.Device manufacturing date not available at time of filing.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).It was reported a message appeared that there was no magnetic field emitted.The cable between the axiem controller box and the monitor was not connected.After the cable was connected and the system was restarted, the orange line did not change to green in the setup equipment screen, and it was noted the number on the back of the axiem controller box was ¿1¿.The usb and the port were wiped with an alcohol swap and the system was rebooted with resolve.There was no further issue.This use occurred preoperatively and did not cause any surgical delay.There was no reported impact on patient outcome.
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Manufacturer Narrative
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The cable was returned to the manufacturer for analysis.Analysis found that there were no issues with the returned cable.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The computer of the navigation system was returned without any accessories and was found to power up and connected with a known good axiem without issue.No issues were found.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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