This report is being supplemented to provide additional information based on results of third-party testing, the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation, and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: (b)(6) 2023.Sampling from: all channels.Cfu: 1 cfu.Bacterial identification: bacillaceae.Sampling date: (b)(6) 2023.Sampling from: all channels.Cfu: 1 cfu.Bacterial identification: micrococcaceae.Additional details were received regarding the cleaning disinfection and sterilization practices (cds) of the user where there were was no suspected patient infection and there were no apparent deviations, deficiencies, or concerns with reprocessing.The device was evaluated where no abnormalities were found that could have led to the positive culture.A few defects were noted where there were scratches on the biopsy channel, the mouthpiece, and the channel mount.The image guide bundle has an abnormal image like a spiderweb.However, these defects alone are not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The reprocessing method is described in the following chapters of the instructions for use: chapter 6 compatible reprocessing methods and chemical agents.Chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.
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