Olympus medical systems corp.(omsc) received a literature titled ¿the endoscopic ultrasound probe findings in prediction of esophageal variceal recurrence after endoscopic variceal eradication therapies in cirrhotic patients: a cohort prospective study¿.The literature reported the result of 153 cases of the endoscopic ultrasound probe examinations (eup) between january 2012 and december 2014.There was a possibility that the endoscopic ultrasound probe examinations (eup) was performed using the subject device.In the subject procedures, 9 cases of esophageal stenosis reportedly occurred as complications.Based on the available information, a direct relationship between the subject device and the reported adverse event could not be determined.Omsc is submitting nine mdrs according to the number of the adverse event.This is 4 of 9 reports.
|