A user facility reported to olympus that there was a concern for infection on the repair request.Upon follow up, it was stated that 11 patient's at the facility were infected with pseudomonas aeruginosa 4 mrgn vim positive.The facility did not have any specifics regarding the patient's and when the procedures occurred, or any other infection details.It was only stated that all 11 patients had procedures between (b)(6)2022 and (b)(6) 2022 with the last detection of the micro-organism in march 2023.It was stated that it became clear to the facility in (b)(6) 2023 that the scope was the cause for infection.The entire cleaning process had been reviewed by local regulatory authorities, including the cleaning machines, and it was found that the reprocessing was adequate.The following outcomes were reported: three of the 11 patients have since died.The facility has clearly communicated that the infection was not the cause of death, but rather, their pre-existing conditions.Eight of the 11 patients are "doing well." one of these eight patients was placed on the liver transplant list after the infection.The facility refused to clarify if it was directly due to the infection or not.As there are 11 total patients, the patient identifiers are as follows: (b)(6).This mdr is for patient identifier (b)(6).
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