MEDTRONIC NAVIGATION, INC. (LOUISVILLE) BIOPSY GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Catalog Number 960-539 |
Device Problems
Unstable (1667); Unintended Movement (3026)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not made available from the site.Device lot number, or serial number, not available.Mfg date: device manufacturing date is dependent on lot number/serial number, therefore, unavailable.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.Part not received by manufacturer.
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Event Description
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A medtronic ent representative received a report from the site that, while in a cranial procedure, their biopsy guide was damaged.The surgeon was using a wench to try and tighten and lock the position, however, it was still too loose.No further details regarding the damage, or how it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy reported.There was no impact on patient outcome.
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Manufacturer Narrative
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Correction: a medtronic representative, following up with the site, reported that the procedure was completed on (b)(6) 2016 and the medtronic representative was not notified of the event until 30-mar-2016.Event date now corrected.
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Search Alerts/Recalls
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