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 the all channels of the device.The testing result cleared the (b)(4) guideline.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 multiple microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.[first time; october 28th, 2020].-all channels: coagulase-negative staphylococci (1 cfu/endoscope).[second time; november 4th, 2020].-all channels: burkholderia cepacia (2 cfu/endoscope).[third time; january 26th, 2021].-unspecified microbes (35 cfu/endoscope).The device had been reprocessed with an olympus automated endoscope reprocessor model etd4 (not available in the usa), using peracetic acid.There was no report of infection associated with this report.
|
This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus france (ofr).Ofr checked the subject device and found the following.- the adhesive of the bending section rubber was worn and torn.- the bending section was damaged, but there were no leak and no sharp edge.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.If additional information becomes available, this report will be supplemented.
|