This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the likely cause of the reported event is due to external stress was applied to lock lever of the connecting tube, which led to breakage of the tube.Subsequently, the tube was unable to be connected.The user may have applied stress toward wrong direction which caused the external stress.The event can be detected by following the instructions for use (ifu) section: 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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