This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned, and an evaluation was completed.During inspection, olympus confirmed the reported event of connecting tube has coating peeling.(1mm2 or more).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 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.The following information is stated in the instructions for use (ifu): 3.3 ¿inspection of the endoscope:¿ 3.¿inspect the external surface of the entire insertion section, including the bending section and the distal end of dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects or other irregularities.¿ olympus will continue to monitor field performance for this device.
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