The suspect device was not sent to olympus for evaluation.A photograph of the device was provided.The photograph showed an object like a hook protruding from the distal end of the device.However, detailed information could not be obtained from the photograph as the image was unclear.The handle was deformed and bent.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device was shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the user could not pull the slider fully due to poor operability due to buckling of the insertion portion, bending of the hook, or the shape and angulation of the endoscope's insertion portion.The deformation of the handle was likely due to stress above the specified value being generated in the handle.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.
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