Olympus medical systems corp.(omsc) was reported that pseudomonas aeruginosa was detected from the stool of two patients.This pseudomonas aeruginosa is not resistant bacteria.No symptoms of infection on the patients had been shown and there was no report of additional treatment to the patients.The user conducted a culture test for all endoscopes and automated endoscope reprocessors in the facility.As a result, two unspecified endoscopes and one oer-3 were test-positive.The water accumulated in the reprocessing basin of the oer-3 was used as the culture sample of the culture test of the oer-3.The type and number of bacteria were unknown.There is no information that a device is specified, which was used for the patients whom pseudomonas aeruginosa was detected from.The local service engineer checked the subject oer-3 and reported that there was no abnormality.This report is the first of two reports of pseudomonas aeruginosa detection.
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This is a supplemental report for mfr report #8010047-2018-02444.Olympus medical systems corp.(omsc) could not investigate the subject oer-3, because the subject oer-3 is not returned to omsc.Omsc checked the device history record of the subject oer-3, there was no irregularity found.Considering the information provided from the user, it was unclear whether the reported infection was caused by the subject device or already existing before the procedure.There were no further details provided.If significant additional information is received, this report will be supplemented.
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