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Catalog Number 9734680 |
Device Problems
Bent (1059); Material Twisted/Bent (2981)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/07/2014 |
Event Type
malfunction
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Event Description
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A medtronic representative reported that, while in a spine procedure, it was discovered that the thoracic probe was bent.No further details regarding the damage, or how it occurred, were provided.There was no patient present when this issue was identified.
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Manufacturer Narrative
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A medtronic representative, following-up at the site, reported that after examination of an image of the suspect thoracic probe, it was determined that the probe was twisted; the damage was not a result of being dropped.No parts have been returned to manufacturer for analysis.Medtronic.
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Manufacturer Narrative
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The site ordered a replacement part, but did not return the suspect instrument.
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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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