Catalog Number 5100060001 |
Device Problems
Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Abrasion (1689)
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Event Date 04/13/2016 |
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.
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Event Description
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It was reported that during a cranial procedure, the perforator bit failed to disengage.It was also reported that there was an unintentional dura opening and bleeding as a result of this event.It was further reported that the procedure was completed successfully.
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Manufacturer Narrative
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The definitive root cause could not be determined.Investigation results indicate that the returned device functioned as intended.
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Event Description
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It was reported that during a cranial procedure, the perforator bit failed to disengage.It was also reported that there was an unintentional dura opening and bleeding as a result of this event.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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