This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Service repair record review showed the following repair record on (b)(6) 2020 for a-rubber replacement, m-case unit replacement, light guide tube replacement.Conclusion: unable to identify a root cause.Based on investigation and information gathered, the following was confirmed.·bending section is stiff and does not return to neutral ·confirmed that a-rubber is stiff and heavy on angulation.·a-rubber glue and insertion tube peeling were confirmed.·unable to identify that the breakage was attributed to whether the stress or handling.·manufacturing record shows no abnormalities on shipment.Unable to identify that the stiff bending section was attributed to whether the excessive stress or improper handling from the above facts.Olympus will continue to monitor complaints for this device.
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