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
No Consequences Or Impact To Patient (2199)
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Event Date 10/15/2015 |
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 crainial procedure, the perforator bit did not stop rotating after puncturing bone.It was also reported that there was no adverse consequences to the patient as a result of this event.It was further reported that the procedure was completed successfully.The delay to the surgery is unknown at this time.
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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 did not stop rotating after puncturing bone.It was also reported that there was no adverse consequences to the patient as a result of this event.It was further reported that the procedure was completed successfully.The delay to the surgery is unknown at this time.
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Search Alerts/Recalls
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