This report is being updated to provide investigation findings and corrected information.D9: device not received , (b)(6) 2021: this is the date a loaner was shipped to the customer.The suspect device was not received by olympus.Olympus requested additional information four times from the customer with no response.For these reasons (no customer response and no device returned), permission could not be obtained to send the scope to a third party lab for culture testing, and physical inspection of the suspect device could not be conducted.The device history record (dhr) for the complaint device has been reviewed and it is confirmed that the device met all design and quality specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: instruction manual on cyf-v2 (reprocessing manual) has detailed instructions explaining proper re-processing methods.Following these instructions may have prevented the phenomenon to occur.Chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Conclusions: the definitive root cause of the reported event could not be identified.Olympus was unable to establish the relationship between the subject device and the patient infection.The following describes the available information: unable to conduct culture test and physical device check.Precise data on each patient, microorganisms identified, date that the scope was used for patient examination, date that the infection was found, was not provided.
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