Olympus medical systems corp.(omsc) was informed that as a result of microbiological testing by the user facility, following microbes were detected from the sample collected from the device.Unspecified channel: escherichia coli (6 cfu/100ml) the device had been manually precleaned with multienzyme (sekusept).The user had used single brushes and stroked 3 times.Then, the device had been reprocessed with an olympus automated endoscope reprocessor (aer) model etd4 or a getinge aer model edflow.The device had been then stored in a olympus drying cabinet model edc.There was no report of infection associated with this report.
|
This supplemental report is being submitted to provide additional information.The device was returned to olympus europa se & co.Kg (oekg).Oekg sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end, forceps raiser and the suction, the instrument, the air/water channels of the device.The testing result cleared the german guideline.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.However, omsc assumed that the reported event was caused by followings; -there was a difference between customers and olympus in how to reprocess the device.-bacteria were contaminated during culture test sampling.If significant additional information is received, this report will be supplemented.
|