CODMAN & SHURTLEFF, INC. CODMAN SURGICAL PATTIE STERILE X-RAY DETECTABLE; PATTIE, COTTONOID
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Catalog Number 80-1402 |
Device Problem
Component Missing (2306)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.
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Event Description
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As reported by the ous affiliate, upon removal from its packaging on the surgical field, surgical patties were lacking the x-ray marker line.10 pieces out of 10 were normal, but the extra one, which was the 11th piece did not have the x-ray line and strings.It was only a piece of cotton.This incident was found when the staff counted the numbers of the devices.There might have been a possibility of intracorporal residual if they had not known there as the extra piece without any x-ray markers.The extra 11th piece has been already discarded.It was unknown if other packages have the extra pieces.They were used carefully in the surgery which concluded successfully.They were disposed of after the procedure.There were no reports of delay or patient harm.The product will not be returned.
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