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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the reported event could not be confirmed.A relationship between the subject device and the reported patient infections could not be identified.However, it was evident that critical reprocessing steps have been skipped by the facility.The root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) in sections: chapter 5: reprocessing: general policy chapter 6: compatible reprocessing methods and chemical agents chapter 7: cleaning, disinfection, and sterilization procedures this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, on (b)(6) 2023, an olympus representative and an olympus endoscopy support specialist (ess) went onsite to the facility and provided the olympus instructions for use (ifu).During the onsite visit, the olympus staff helped the facility gather information on items needed to properly clean the scopes (e.G., bins, brushes, and a leak tester, etc.).Also, an in-service has been planned for when the proper equipment is onsite at the facility.Olympus will continue to monitor field performance for this device.
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