Catalog Number 1830717FRT |
Device Problem
Imprecision (1307)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2014 |
Event Type
malfunction
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Event Description
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A medtronic ent representative reported an alleged inaccuracy occurring while in an ear, nose & throat (ent) procedure, using the fusion navigation with the frontal balloon.The surgeon used an endoscope to confirm accuracy of placement and determined it was correct.The surgeon continued and completed the procedure with the use of the navigation system.There was no impact on patient outcome.
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Manufacturer Narrative
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Patient information was not made available from the site.Device manufacturing date is unavailable.A medtronic representative, following-up at the site, reported the suspect balloon seeker was disposed of by the site.No parts will be returned to manufacturer for analysis.A medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.
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Manufacturer Narrative
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Patient identifier was not provided by the site.Patient age, sex and weight provided.Use by date and device manufacture date provided.
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Search Alerts/Recalls
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