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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Tissue Damage (2104)
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Event Date 07/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation, a follow up report will be filed.
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Event Description
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As reported by the ous affiliate, a perforator did not disengage and pierced the dura.
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Manufacturer Narrative
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The affiliate was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.We will continue to monitor for this or similar complaints for this product code.A review of the lot history records did not show any anomalies during the manufacturing process.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.
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Search Alerts/Recalls
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