Model Number FUSION |
Device Problem
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
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Event Description
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A manufacturer representative reported that, while in a functional endoscopic sinus surgery (fess), the navigation system became unresponsive without prompt from the user.The representative reported that the navigation system was restarted without resolution as the navigation system became unresponsive at the navigation task in the application software.It was noted that a third restart restored functionality.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.No additional information was provided.
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Manufacturer Narrative
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Additional information: device manufacture date and unique device identification (udi) provided.Correction: product and related fields updated to proper value.The computer for the navigation system 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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Manufacturer Narrative
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Correction: a medtronic representative went to the site to test the equipment.Testing revealed that the computer of the navigation system was replaced to restore functionality.The system then passed the system checkout and was found to be fully functional.The computer of the navigation system was returned to the manufacturer for evaluation.Testing found that the cpu or mb of the computer had a failure.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
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Search Alerts/Recalls
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