This report is being supplemented to provide additional information based on the legal manufacture¿s final investigation.Despite good faith attempts the user culture results and cleaning disinfection and sterilization (cds) processes were not shared.Based on the results of the investigation, because the user culture results were not shared, and because the subject device was not returned, the reported event could not be confirmed, and a root cause could not be determined.The reported event was not confirmed as the scope was not microbiologically tested by olympus.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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