The device history record was reviewed.Visual and functional in-process inspection is conducted by the manufacturing operator and qc inspectors.Visual inspection includes 100% verification of proper assembly and ring alignment, foreign matter, and review of assembly for general workmanship and broken or defective components.Functional inspection includes 100% doppler signal verification and a sampling for the destructive tests: ring separation and probe scabbard retention test.The coupler separation force is within specification.The probe scabbard retention force is within specification.The ring retention force test results were within specification.The released lot met product specification.The wing jaw assembly, left and right flow-coupler rings, the doppler probe, and the flow-coupler external extension wire were returned for evaluation.The wing jaw assembly, without rings, was loaded onto an anastomotic instrument and cycled several times.The left and right wings moved together smoothly.The returned rings were evaluated under microscope.There are physical marks on the ring surface that indicate that the rings were brought together misaligned.There is no evidence to suggest why the rings became misaligned.The occurrence can be influenced by the surgeons' technique.The rings are designed to slide out of the jaw and could be moved prematurely when the tissue is everted onto the ring.Should additional relevant information become available, a supplemental report will be submitted.
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