The subject device had not been returned to olympus medical systems corp(omsc).But was returned to olympus (b)(4).The subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, the testing indicated no microbial growth for the subject device.The physical findings of the subject device were not reported.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 is received, this report will be supplemented.
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Olympus was informed that as a result of microbiological testing by the user facility, the subject device repeatedly tested positive for the following bacteria: on (b)(6) 2019: total: staphylococcus hominis (2cfu).On (b)(6) 2019: total: staphylococcus cohnii (1cfu).On (b)(6) 2019: total: staphylococcus hominis (1cfu).On (b)(6) 2019: total: staphylococcus warneri (1cfu).The subject device had been brushed manually using a non-olympus cleaning brush (clean, ref: an1053007) and disinfected manually with peracetic acid (anioxy twin).There was no report of patient infection associated with this report.
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