The device history record was obtained and reviewed for lot # sp16e10-1149641.The lot passed visual and functional inspection.The coupler ring separation force results noted in the dhr for this lot were within specification.The coupler ring retention force test results were within specification.One hundred percent functional alignment testing was performed on each device during the manufacturing process.In addition, 100% visual inspection for broken or missing parts was performed.The released product met specification.Product was not returned.Physical description could not be obtained.Functional testing could not be performed.The root cause of the event could not be determined.The dhr review indicates that the lot met specification.There is no immediate evidence to support why the ring did not stay connected during use.Should additional relevant information become available, a supplemental report will be submitted.
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