Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The codman disposable perforator was returned for evaluation.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.Unit was soiled with organic matter and had a worn "eo" label.Ifu testing procedure was performed and the following was observed; unit had a frozen inner/outer drill and ¿sticky¿ hudson end, the unit was freed from this position and the test was performed as intended.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The unit was found to perform as intended and fulfilled the acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.
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