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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
Brain Injury (2219)
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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 distributor, a perforator did not disengage, becoming "stuck in the patient's skull" and also "struck the patient's brain.".
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Manufacturer Narrative
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The perforator was not returned for evaluation/repair.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.If the product is returned in the future, this complaint will be reopened and a followup report will be filed.At the present time this complaint is closed.
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Search Alerts/Recalls
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