E2, e3, & g2: additional information has been provided.This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the legal manufacturer's investigation, and the inability to evaluate the subject device, a definitive root cause of the reported event could not be identified.However, it¿s likely the cause is related to external stress applied to the lock lever of the connecting tube, which broke the lever and caused the tube¿s inability to be connected.As for the cause of the external stress, the user may have applied force toward an incorrect direction.The suggested event is detectable by following the instructions for use which state: 9 preparation and inspection 1) visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.3) move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.Olympus will continue to monitor field performance for this device.
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