Olympus medical systems corp.(omsc) received the jddw2019 literature "w1-2: treatment results of transbiliary anatomy using spyglass ds for difficult to treat bile duct ligation, comparison with conventional transcholangioscope".The literature reported the result of 15 cases of the lithotripsy using peroral cholangioscopy (pocs) procedures using an olympus model chf-b260 between december 2006 and november 2015.In the subject procedures, 3 cases of cholangitis reportedly occurred.Based on the available information, a direct relationship between the subject device and the observed reported adverse events could not be determined.Omsc is submitting three mdrs according to the number of adverse events.This is 2nd of 3 reports.
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