The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, the sample collected from the instrument channel of the device tested positive for unspecified microbes (10 cfu/channel) and the air/water channel of the device tested positive for unspecified microbes (7 cfu/channel).The testing result cleared the german guideline.Ode checked the subject device and found following.The bending section rubber adhesive was damaged.The electrical connector had leakage.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Unspecified microbes (2 cfu), pantoea septica (8 cfu), moraxella osloensis (6 cfu) the device had been reprocessed with a non-olympus automated endoscope reprocessor, innova e4, using aldehyde.There was no report of infection associated with this report.
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