This report was submitted by the importer under the importer's report number 2429304-2023-00284.The olympus endoscopy support specialist (ess) was on-site for observations of bedside cleaning with respiratory staff.During observations, the ess noticed that the endobronchial ultrasound (ebus) 180 scopes were not having the irrigation channel flushed with detergent.Additionally, the same precleaning sponge and detergent mixture was being used on bronchoscope and ebus 180 scope used during procedure of the same patient.The ess completed a reprocessing in-service to correct deviations and provided customer with scope cleaning wall charts.The customer stated that they will send in all bronchovideoscope and ebus 180 scopes to olympus service center for scope evaluations for damage.Re-training for the correct handling was completed.The subject device was not returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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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 final investigation, since detailed information regarding the patients was not provided by the customer, a relationship between the subject device and the reported patient infections could not be identified.Also, regarding the improper reprocessing of the device, it was determined that the user¿s understanding differed from the olympus recommendation in device handling and/or reprocessing steps.Therefore, the root cause could not be determined.As previously reported, an olympus specialized staff member already provided training in correct handling.The event can be detected/prevented by following the instructions for use (ifu) in section: ¿reprocessing manual: chapter 5 - preventive measures.Reprocessing the endoscope (and related reprocessing accessories)¿.Olympus will continue to monitor field performance for this device.
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