Model Number S7 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Unique device identification(udi) is not available.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the computer was replaced.The system then passed the system checkout and was found to be fully functional.The computer was returned to the manufacturer for analysis.The computer 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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Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess) procedure.The issue occurred intraoperatively during the register task and delayed surgery by less than one hour.It was reported that after registration and in navigate the screen went blank then blue.The site shut down the system and completed the surgery without navigation.There was no known impact on patient outcome.
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Manufacturer Narrative
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Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.A software analysis was initiated to determine the probable cause of the issue through known anomaly determination.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.
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Search Alerts/Recalls
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