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 12/02/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Awaiting device evaluation.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 did not stop and tore the dura.It was also reported that there was surgical delay of 10 minutes.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.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 did not stop and tore the dura.It was also reported that there was surgical delay of 10 minutes.It was further reported that the procedure was completed successfully.
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Search Alerts/Recalls
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