This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Leaking was observed through the pinhole.Based on the results of the investigation, the definitive root cause of the reported event could not be determined.The workflow of preparation and inspection is instructed as follows "before each case, prepare and inspect this endoscope as instructed below.Inspect other equipment to be used with this endoscope as instructed in their respective instruction manuals.Should any irregularity be observed after inspection, follow the instructions as described in 'chapter 5, troubleshooting'.If this endoscope malfunctions, do not use it." olympus will continue to monitor field performance for this device.
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