The subject device has not been returned to omsc but was returned to olympus (b)(4) (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 and the forceps elevator and the suction, the instrument, the air/water channels of the device.The testing result cleared the german guideline.Oekg checked the subject device and found that following.The bending section rubber adhesive had been peeled off.The bending section rubber had been worn out.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 multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.[first time; (b)(6) 2020] -staphylococcus epidermidis (6 cfu) [second time; (b)(6) 2020] -bacillus species (49 cfu), coagulase-negative staphylococci (7 cfu) [third time; (b)(6) 2020] -gram-positive staphylococci (2 cfu) the device had been reprocessed with a non-olympus automated endoscope reprocessor, santax mds instrument washer using peracetic acid.There was no report of infection associated with this report.
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