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 event was unable to be identified.The foreign object was unable to be identified.A leak failure, due to a forceps channel pinhole, occurred in the forceps channel.Therefore, reprocessing could not be completed.The acoustic lens likely chipped, due to physical stress or impact from falling.The event can be detected/prevented, by following the instructions for use, which are described in the following chapters: chapter 4.: flow of reprocessing work for endoscopes and accessories and chapter 5.: reprocessing of endoscopes (and accessories, that are reprocessed together).Olympus will continue to monitor field performance for this device.
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