Olympus medical systems corp.(omsc) received a literature titled ¿clinical study of pcnl and urs for kidney stones with a major axis of 20 mm or more¿.The literature reported the result of 31 cases of ureterorenoscopy (urs) between january 2013 and december 2017.There was a possibility that urs was performed using the urf-p6.In this literature, it was reported adverse events as follows; ureteral injury: 2 cases.Fever: 4 cases.Fever (septic shock): 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 seven mdrs according to the number of the adverse events.This is 1 of 7 reports.(1 of 2 ureteral injury cases).
|