Updated fields: d4, d9.G3, g6, h2, h3, h4, h6, h10.The original codman perforator (261221) was not returned for evaluation, units from the same lot number were returned.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.The original unit was not preserved for return, so 3 unused units from the same lot were returned in place of the original unit.Ifu (instructions for use) testing procedure was performed with no observed anomalies.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release and the units were found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.Root cause - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.The potential causes of failure include user misuse.
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