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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Code Available (3191)
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Event Date 06/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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Udi: (b)(4).The device has been returned for evaluation.Upon completion of the investigation.A follow-up report will be submitted.
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Event Description
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It was reported that the perforator failed to disengage and product came out from the drill and got stuck in the bone when the surgeon made the craniotomy.Therefore, the surgeon enlarged the craniotomy range, and removed it from the patient.The dura was not damaged, but the product approached to the limit.No further information was provided by hospital.The product will be returned to your site.
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Manufacturer Narrative
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The device was returned for evaluation.The perforator was visually inspected.No anomalies were observed, other than a missing product label.Functional testing was then performed.A series of holes were drilled per the test method without issue.A review of manufacturing records could not be performed, as no lot number was provided.Based on the investigation, the reported issue could not be found.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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