This report is being supplemented to provide additional information based on the device evaluation and 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 (3) years since the subject device was manufactured.The legal manufacturer confirmed that the customer's reprocessing steps were in accordance with the instructions for use: based on the results of the investigation, olympus confirmed that foreign material remained on the objective lens, component analysis revealed that the foreign material was a mixture of drug-derived organic silicone and silicic acid and a mixture of human-derived protein and sodium chloride.There was no physical damage to the location of the foreign material.The cause of the material remaining in the device could not be determined.Olympus confirmed that the inspection method for this event is described in the reprocessing manual "chapter 5, section 5.5 manual cleaning of endoscopes and accessories" and "chapter 8 storage and disposal," especially when reprocessing air and water supply.Confirm that stain has been removed from the nozzle opening and objective lens surface.If the stain remains, clean until all of the stain is removed, rinse thoroughly, and remove any residue in the channel after cleaning.Please check the handling environment, such as draining water and drying.Olympus will continue to monitor field performance for this device.
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