This supplemental report is being submitted to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The distal part of the subject device was visually checked and was observed at a magnification of 40 times with a microscope, but no debris or foreign object was found.Omsc checked the four devices of the user with the same model including the subject device at a magnification of 40 times.It was confirmed that foreign objects remained at an invisible level on the two devices of them.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the evaluation, it would be possible to further improve the cleaning quality by increasing the number / frequency of brushing to the distal part.
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