The event unit was returned for evaluation.Upon observation, engineering was able to confirm that the bag was missing.A review of the device history records for lots sold to this customer confirmed that the unit passed all manufacturing and quality inspections.The root cause of the bag missing is unknown.Engineering found damage on an internal component that suggests the device had been deployed once before.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.
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