Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative inspected the imaging system on-site.The reported issue could not be replicated during inspection.A full navigation system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.
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Event Description
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A site representative reported that during a cranial resection procedure, the navigation system was inaccurate.It was reported that the patient reference with fiducials was not accurate.Navigation was discontinued because of this issue.There was a reported delay to the procedure of less than 1 hour due to this issue.The procedure was completed successfully without the use of navigation, and the patient was not impacted.No additional details were provided.
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Manufacturer Narrative
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The software investigation found that the reported event was unrelated to a software issue.Image analysis performed found that the fiducials were placed on the back of the head and localized.It was recommended to the site that the fiducials be spread out.The software functioned as designed.
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Search Alerts/Recalls
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