The forceps elevator was replaced according to an olympus field corrective action on (b)(6) 2016.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was sent to a third party laboratory for additional microbiological testing.In the test, the test result indicated no microbial growth for the subject device.After the additional microbiological testing, ofr continued with the incoming inspection in the repair center.During incoming inspection the endoscope passed the leakage test successfully and olympus performed a technical evaluation.Olympus found signs of wear and tear at the distal end of the subject device as there were slight angle-rubber damages and cementing deterioration that were classified as "minor" repairs.The exact cause could not be determined at present.Olympus is planning to follow up with the facility to obtain additional information.If significant additional information is received, this report will be supplemented.
|
This supplemental report is being submitted to provide additional information.On october 19, 2017, olympus (b)(4) received an incident report from (b)(6) authority and was informed about additional 2 cases of infection (total 4 cases of patient ¿infections and/or colonization of high resistant bacteria¿) at the facility.The incident report also reported that the subject device was returned from repair on july 20, 2017.This is one of four reports.
|