The customer requested reprocessing in-service due to issues with bronchoscope reprocessing and stated that they have had multiple instances where patient specimens tested positive for penicillium species after bronchoscopy cases.The endoscopy support specialist (ess) performed reprocessing observations at the facility and noted deviations to instructions for use (ifu) reprocessing instructions.During manual cleaning it was noted that the scopes were flushed with detergent solution instead of aspirating.After manual cleaning and rinsing, the scopes were placed in oer-pro reprocessor for reprocessing.This event is reported under the following related patient identifiers (b)(6), (b)(6) and (b)(6) to capture the multiple instances where patients tested positive for penicillium species.This medwatch report is for patient identifier (b)(6).
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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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