The subject device was returned to olympus (b)(4).(b)(4) checked the subject device and removed both the subject device and the guide sheath at the same time and they passed through the endoscope with no difficulties.Then the subject device was returned to omsc for investigation with stuck in the guide sheath.Omsc checked the subject device and found following; - the subject device had a cut inside the guide sheath - the x-ray tip of the guide sheath was deformed and became oval shape, also the tube of the guide sheath was kinked.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Based upon the investigation, omsc surmised that the reported phenomenon was attributed to the stress was applied to the x-ray opaque tip due to the angle of the endoscope was strict when the endoscope was inserted.The phenomenon was caused by crashed radiopaque tip being deformed and stuck inside the guide sheath.Crashed radiopaque may have been attributed to a load applied to it when angulation too much during insertion of the endoscope.Olympus stated the appropriate handling of um-s20-17s and the counter measures against abnormalities in the instruction manual of um-s20-17s.
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