On may 11, 2018, olympus medical systems corp (omsc) received a literature titled ¿safety and efficacy of endoscopic bile duct stone treatment procedure for elderly people who experienced intestinal reconstructive surgery.¿ that was made in public in the 95th congress of the japan gastroenterological endoscopy society on may 2018.The literature reported the result of 186 cases (285 procedures) of endoscopic bile duct stones treatment using single balloon endoscopy (sbe) for the elderly people between january 2007 and september 2017.In the subject procedures, accidental symptoms reportedly occurred as follows: pancreatitis occurred in 9 procedures; intestinal perforation occurred in 5 procedures; cholangitis occurred in 5 procedures; bleeding occurred in 3 procedures; leakage pancreatic juice occurred in 1 procedure; bile duct perforation occurred in 1 procedure.The literature concluded that, it was suggested that the procedure can be performed safety and effectively for even if the patient was elderly people (more than 75 years old) who experienced intestinal reconstructive surgery.Omsc reviewed the delivery history of the endoscopes (sbe type) and the history revealed that olympus small intestinal videoscopes (sif-y0004, sif-y0004-v01, sif-y0015, sif-h290s, sif-q260) had been delivered to the facility.Olympus is submitting mdr according to the number of procedural accidents case because it was not informed which endoscope model was used in the procedures.This is 17 of 24 reports.
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