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Catalog Number 9734680 |
Device Problems
Bent (1059); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/12/2015 |
Event Type
malfunction
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Event Description
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A medtronic representative received a report that, while in a spine procedure, the site's straight thoracic probe was bent.No further details regarding the damage, or how it occurred, were provided.The surgeon 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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Return requested.Medtronic investigation of returned suspect device finds that, as reported, the tip of the instrument is severely bent to one side.There are also many impact marks at the back end of the probe.Physical damage - bent instrument tip - directly caused event.
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Manufacturer Narrative
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Correction: on 13-oct-2015, it was noticed that a previous mdr submission contained incorrect information with regards to the common device name, product code and/or pma/510(k).This mdr is being submitted to correct this information.There is no new information to change the patient information, event description or manufacturer narrative that was previously reported.
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Search Alerts/Recalls
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