This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Additional information added to field h3, h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 09 years since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint of air/water channel blockage was confirmed.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and there were no obvious deviations from the cleaning disinfection and sterilization (cds) steps provided in the instructions for use (ifu).Therefore, the cause of the material remaining in the device could not be determined.The instruction manual states the detection method associated with the event in "gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection", and preventative measures in "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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