Olympus medical systems corp.(omsc) received a literature titled "endoscopic submucosal dissection with additional radiotherapy in the treatment of t1a esophageal squamous cell cancer: randomized controlled trial" the literature reported the result of 70 patients with t1a early esophageal squamous cell carcinoma (escc) of endoscopic submucosal dissection (esd) procedure using the olympus single use electrosurgical knife kd-611l or kd-650q between january 2015 to september 2018.In the literature, it was reported complication as follows; perforation (3 cases), stenosis (18 cases), radiodermatitis (1case), esophagitis (1 case), leukocytopenia (2 cases), immediate surgical resection after esd (4 cases).There are not mentioned that these complications were related to the product in question.Of these, the perforation has been treated endoscopically.Therefore, the omsc assume it not to be a serious event.Omsc assumes that the "immediate surgical resection after esd" might be related to the subject device and serious events.Therefore, omsc assumes that the "immediate surgical resection after esd" was an adverse event to submit.Based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.Omsc will submit one medical device report (mdr) of the subject device for the "immediate surgical resection after esd".
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