Model Number 9733560XOM |
Device Problem
Application Program Problem (2880)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device serial number unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.The system passed the system checkout and was found to be fully functional.No parts on the system were replaced.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 that the site had a red status on the patient tracker, and the patient tracker was unable to be used.The site swapped for another patient tracker and the issue was resolved.The site disposed of the patient tracker that wasn't working.This issue was observed intraoperatively.There was a surgical delay of 5 minutes, and there was no impact on patient outcome.A medtronic representative noted that this issue had not occurred again in a clinical case since the day of the reported event.
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Manufacturer Narrative
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Additional information: a software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that hardware issue is suspected since the issue was resolved by swapping patient tracker.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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