This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device, since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely, that the external stress caused the detachment of the lock lever from the connecting tube.However, a definitive root cause could not be determined.The following is included in the instruction for use (ifu): 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.2.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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