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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 05/25/2017 |
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 didn't disengage, tearing the patient's dura.The device will be returned.
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Manufacturer Narrative
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The affiliate was contacted regarding product return; 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 dhr 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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