The customer reported to olympus that during routine microbiological testing, the evis exera iii duodenovideoscope tested positive for an unexpected contamination.The testing was performed after a therapeutic endoscopic retrograde cholangiopancreatography procedure.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.Additional information from the olympus employee reported that upon follow-up at the site and discussing the positive culture report with the customer, it was discovered the facility had two potential patients post procedure infections.Both instances the patient had an ercp- endoscopic retrograde cholangiopancreatography procedure before the infection and a culture positive scope was used in the procedure.The customer has not disclosed the date the scopes were cultured, and the type/growth of microbiological organism tested.The facility is reported to be inquiring further details from the infection prevention control.2 similar occurrences have been reported by the customer for patients having post-procedure infections at their facility with the patient identifiers: 1) patient identifier # (b)(6) evis exera iii duodenovideoscope tjf-q190v, sn (b)(6).2) patient identifier # (b)(6) evis exera iii duodenovideoscope tjf-q190v sn -unk (this report).
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