Model Number FUSION |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); 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 03/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Unique device identifier (udi) is unavailable.Device manufacture date is unavailable.A medtronic representative went to the site to test the equipment.It was reported that the application software was re-installed with resolution.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced, therefore no parts were 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.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: unique device identification (udi) and device manufacture date provided.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 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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The software investigation 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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Manufacturer Narrative
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Correction: unique device identification (udi) inadvertently not included on supplemental mdr 1723170-2018-01355 sequence number 1.
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Search Alerts/Recalls
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