This supplemental report is being submitted to provide the legal manufacturer's final investigation.Additional information: d8, h3, h4 and 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 eleven (11) years since the subject device was manufactured.A definitive root cause was not identified nor the type of material, however based on the results of the investigation, the probable cause of the "air/water channel had foreign material." malfunctions would likely be related to the reprocessing that was not conducted properly due to a leaking from the bending section cover.The event can be prevented by following the instructions for use which state: ifu states the detection method in gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Ifu states the preventive measure 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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