This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The red foreign matter was returned to omsc for the analysis of component.The result of the component analysis, it was found that the red foreign matter was mainly composed of polysaccharides such as cellulose and was not fibrous.The red foreign matter may be mold, chemicals, residue of the reprocessed endoscope, etc., but it could not be identified.If additional information becomes available, this report will be supplemented.
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