Catalog Number 5100060001 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Abrasion (1689)
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Event Date 01/11/2015 |
Event Type
Injury
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Event Description
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It was reported that during a procedure the perforator continued to drill without stopping.It hit the dura and tore it slightly on the cortical side of the brain.It was further reported that the event caused some bleeding which was stemmed quickly by the surgeon.The surgery was completed successfully.A delay of 5 minutes was reported.The patient is reported to be well with no further medical intervention being required as a result of this event.
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Event Description
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It was reported that during a procedure the perforator continued to drill without stopping.It hit the dura and tore it slightly on the cortical side of the brain.It was further reported that the event caused some bleeding which was stemmed quickly by the surgeon.The surgery was completed successfully.A delay of 5 minutes was reported.The patient is reported to be well with no further medical intervention being required as a result of this event.It was subsequently reported that nothing unusual was seen on any ct scans performed after the procedure.
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Manufacturer Narrative
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The device is not available for return.A follow up report will be filed once the quality investigation is complete.Device discarded by customer.
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Manufacturer Narrative
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A review of the manufacturing records for the reported device has not revealed any discrepancies.The quality investigation is complete.Device disposed.
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Search Alerts/Recalls
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