On november 2, 2018, olympus medical systems corp.(omsc) received a literature titled ¿study on endoscopic treatment using short-type single balloon endoscope(short-sbe) for stenosis in postoperative choledochoduodenostomy¿ that was made in public in 26th japan digestive disease week.The literature reported the results and accidental symptoms in 34 procedures of short-sbe, in which balloon dilation using subject device were conducted for the stenosis.It was also reported that the 1 cases of accidental symptom (digestive perforation) occurred.Omsc reviewed the delivery history of the endoscopes and the history revealed that olympus small intestinalvideoscopes (model sif-h290s) had been delivered to the user facility.In the procedures, the sif-h290s and olympus single use splinting tubes (st-sb1s) were possibly used.Omsc tried to obtain additional information from the user facility, but additional information was not provided at present.Omsc is submitting one mdr according to the number of reported perforation case in each type of device (small intestinal videoscope and splinting tube).
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