This supplemental report is being submitted to provide the results of the manufacturer's investigation.A review of the device history record (dhr) and a review of the instructions for use (ifu) were conducted as part of the investigation.The dhr review did not find any abnormalities or anomalies identified during production.The device met specifications upon release.The root cause could not be established.Possible causes of the connector breaking include user added stress or impact with a hard object, causing the connector to become loose then break.Possible causes of the cracked lid include contact with a scope/hard object or age deterioration.The ifu contains the following statements that may prevent connector breakage: "check the following for each connector: the connector should be fixed firmly.The o-rings should be free of abnormalities such as cracks, tears, or dents." the ifu contains the following statements that may prevent a cracked lid: "before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.The lid is not cracked, broken, or otherwise damaged." olympus will continue to monitor the field performance of this device.
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