The device was not returned to olympus, and it is not expected to be returned for evaluation.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.The investigation is ongoing; a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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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, it is likely that stress was applied to connecting tube by hitting with something, which made endoscope side connector come off the tube.The event can be prevented by following the instructions for use (ifu) which state: "chapter 5 inspection and preparation before use 5.7 inspecting the connecting tubes and leak test air tube before using the reprocessor, always check that there is no irregularity regarding the following points on the connecting tubes and leak test air tube.All tubes should be free of cracks, breaks, fissures, scratches, or stains.There should be no cracks in the lock levers of connecting tube connectors and leak test air tube connectors.There should be no bends or breaks in the pin of connecting tubes connector and leak test air tube connector.The tube should not be easy to disconnect once connected." olympus will continue to monitor field performance for this device.
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