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, no microbe was detected from the sample collected from all channels of the subject device.The testing result cleared the (b)(6) guideline.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.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.
|
Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from all channels of the subject device tested positive for staphylococcus sciuri and staphylococcus epidermidis.The total cfu of the staphylococcus sciuri and staphylococcus epidermidis is >100cfu.The device had been reprocessed with a non-olympus automated endoscope reprocessor, wassenburg, using peracetic acid.There was no report of infection associated with this report.
|