This report is being supplemented to provide additional information based on 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.Based on the results of the investigation, it is likely physical stress was applied to insertion section, stress from inferior storage environment (in direct sunlight, at high temperatures, in high humidity or exposed to x-rays and/or ultraviolet-rays, etc.), and chemical stress from reprocessing not recommended by instructions for use (ifu) caused the coating to peel.However, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
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