Olympus medical systems corp.(omsc) received a literature titled ¿a study on the safety of endoscopic nipple large diameter balloon dilatation for antithrombotic patients: a multicenter retrospective study¿.The literature reported the result of 144 cases of the endoscopic papillary large balloon dilation (eplbd) procedure without endoscopic sphincterotomy (est) procedure using olympus duodenovideoscope model jf-260v or tjf-260v and non-olympus balloon catheter from march 2008 to december 2017.In the subject cases, 1 case of aspiration pneumonia occurred.Based on the available information, a direct relationship between the olympus products and the observed adverse events could not be determined.Therefore, omsc will submit 2 medical device reports (mdr) depending on the type of device.This report is 2 of 2 reports at tjf-260v.
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