This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue were identified.Based on the results of the investigation, it was presumed that the coating in the insertion section had peeled off due to physical stress, such as rubbing, hitting or inferior storage environment (direct sunlight, high temperature, high humidity, or exposure to high-energy electromagnetic radiation, ultraviolet rays, etc.), or chemical stress from reprocessing not recommended in the instructions for use.The absence of an image was likely caused by conduction failure or circuit board breakage due to fluid invasion in the distal sheath of the device.However, the definitive root cause could not be determined.The event can be detected by following the instructions for use which state: 3.2 inspection of the endoscope: inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities.Olympus will continue to monitor field performance for this device.
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