Olympus medical systems corp.(omsc) received a literature titled ¿the usefulness of endoscopic treatment for intrahepatic stone disease¿.The literature reported the result of 57 cases of the treatment for intrahepatic calculosis procedures between 2003 and 2018.There was a possibility that sbe-ercp (single balloon enteroscopy endoscopic retrograde cholangiopancreatography) was performed using the sif-y0004.In this literature, it was reported adverse events as follows after the procedures; cholangitis occurred in 3 cases.Recurrence of intrahepatic stone disease occurred in 4 cases.Liver abscess occurred in 1 case.Bile duct cancer occurred in 1 case.Based on the available information, a direct relationship between the subject device and the reported adverse events could not be determined.Omsc is submitting nine mdrs according to the number of the adverse events.This is 8 of 9 reports.(liver abscess).
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