The endoscopy support specialist (ess) noted that the facility did not have adequate supplies to complete the reprocessing process, there were no acecide test strips for testing the me c of the disinfectant prior to starting the cycle with the oer-pro.The ess scheduled an in service for (b)(6) 2024 and the customer has been provided with documentation to include the acecide-c instruction manual, as well as the quick reference guide, testing strip log.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.User can prevent the suggested event by following ifu below."preventive measure is described in ifu: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope." olympus will continue to monitor field performance for this device.
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