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Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The affiliate advised that the perforators (2 perforators) will not be returned.As such it is not possible to evaluate the product and determine the root cause of this complaint.Furthermore, the lot number for the subject product was not reported; therefore, the lot history records cannot be reviewed.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed.Device not available.
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Event Description
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On (b)(6), the safety mechanism did not work and it continued to rotate without stopping when the "transforation" was performed by the drill's cutting edge at 2 times in a row.The first time used the product after re-sterilization, so it was suspected that re-sterilization was the cause of the issue.The second time used it as a brand new but the safety mechanism did not work as well.There was no surgical delay and no adverse consequence to the patient.No further information was provided by the hospital.The products will not be returned to your site.
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Search Alerts/Recalls
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