Model Number 9735736 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 from a manufacturer representative (rep) regarding a navigation system being used for a fess procedure.The manufacturer representative (rep) indicated they were having difficulties registering.With the patient tracker turned on they were getting around 5.9 and the rep indicated that they ensured they followed a good trace pattern with green dots.After removing the patient tracker a re-trace was done and it dropped to 1.3.The delay in surgery was less than one hour and there was no impact or change in patient outcome.There were no further complication reported or anticipated.
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Manufacturer Narrative
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A software analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that insufficient information to determine why there was a difference in registration metrics with cad initialization and without." if information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that all components passed checkout.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the manufacturer representative (rep) who indicated that they were able to register the blue demo head with and without the tracker being turned on.When the tracker was on the rep got a 0.8 and with the tracker being off the rep got a 0.9, however the archive was no longer available at the time the rep was on site as the data had been deleted.
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Search Alerts/Recalls
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