This report is being supplemented to provide additional information based on the results of third-party testing, the device evaluation, and legal manufacture¿s final investigation.Despite good faith attempts the user cleaning disinfection and sterilization (cds) processes were not shared.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: mar 13, 2024 sampling from: distal end cfu: no detection bacterial identification: n/a sampling from: biopsy channel/suction channel cfu: 0 cfu/ml bacterial identification: n/a the device was evaluated where no abnormalities were found that could have led to the positive culture.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 and because the user culture results were not shared, the reported event could not be confirmed and a root cause could not be determined.Growth of microorganisms were reported through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with the instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ olympus will continue to monitor field performance for this device.
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