This report is being supplemented to provide additional information based on the legal manufacturer's 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, it is likely that external stress was applied to lock lever of the connecting tube in the wrong direction, which led to breakage of the tube.Subsequently, the tube was unable to be connected.However, the root cause of the reportable malfunction could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: 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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