Catalog Number 5100060001 |
Device Problems
Use of Device Problem (1670); Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sinus Perforation (2277)
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Event Date 10/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop and tore the sinus.No further information was provided.
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Manufacturer Narrative
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The definitive root cause could not be determined and potentially failure to follow instructions caused or contributed to this event.
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Event Description
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It was reported that during a cranial procedure, the perforator bit did not stop and tore the sinus.It was also reported that there was no delay as a result of this event and the procedure was completed successfully.
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Search Alerts/Recalls
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