MEDTRONIC NAVIGATION, INC. (LOUISVILLE) OSTIUM SEEKER, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Catalog Number 9733448 |
Device Problems
Bent (1059); Imprecision (1307)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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On 02/12/2016 a medtronic representative performed a navigation system check-out, hardware and software areas passed.Instruments test failed.Ostium seeker failed to verify the lowest geometric error was down to a range of 3.2 to 4.3.No issues verifying any other instruments including both straight suctions.On 02/22/2016 a medtronic representative, following-up at the site, reported the straight suction verified successfully during his system check-out.The medtronic representative confirmed that the site is properly trained on verification, metal interference, and emitter placement.During the check-out, the medtronic representative determined that the site's ostium seeker was bent, and would not verify.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.
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Event Description
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A medtronic representative reported that, while in an ear, nose & throat (ent) procedure two days earlier, the surgeon alleged an inaccuracy with the straight suction.The surgeon deemed registration was satisfactory, as well as, accurate with all other instruments.The surgeon opted to continue the procedure using a second straight suction.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.There was no impact on patient outcome.
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Search Alerts/Recalls
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