Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Sinus Perforation (2277)
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Event Date 01/16/2017 |
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.Device discarded by customer.
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Event Description
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It was reported that during a retro mastoid cranial procedure, the perforator bit did not stop and tore the sinus.It was further reported that the surgeon managed to stop the bleeding after 2-3 minutes in surgery and there were no adverse consequence for the patient.It was also reported that the procedure was completed successfully.
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Manufacturer Narrative
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The quality investigation is complete.
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Event Description
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It was reported that during a retro mastoid cranial procedure, the perforator bit did not stop and tore the sinus.It was further reported that the surgeon managed to stop the bleeding after 2-3 minutes in surgery and there were no adverse consequence for the patient.It was also reported that the procedure was completed successfully.
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Search Alerts/Recalls
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