Model Number 9735602 |
Device Problem
Human-Device Interface Problem (2949)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Udi was not available on the date of filing.The site at which the event occurred and some of the initial reporter information was not available at the time of filing.No devices/components were returned to the manufacturer on the date of filing.Manufacture date was not available on the date of filing.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 system.It was reported outside of a procedure that the axiem would not connect to the emitter.The site plugged the emitter into the axiem box and it would not connect or give the fluttering sound.The site tried another emitter from a fusion and that one didn't work either.There was no patient present.
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Manufacturer Narrative
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The axiem and the axiem cable were returned to the manufacturer for analysis.Analysis found no fault or failure with either of these components after visual/physical examination and functional testing.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: facility name provided.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 additional information that the issue was noticed during the trial set up of the system.This system was a trial system for in office balloon case.The case continued with a system that was owned by the site.This issue was discovered before the patient was present.
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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 additional information that a manufacturer representative performed troubleshooting with technical services (ts) and determined that the emitter needed to be replaced.After replacing the axiem box, a system checkout was performed and everything worked to specification.
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Manufacturer Narrative
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Correction: updated with the correct system information.A medtronic representative went to the site to test the equipment.It was reported that the issue could not be confirmed or replicated, no components were replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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