The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.However, omsc launched only products that had passed the inspection.The malfunction of the subject device concerning this case has not been reported, and there is no information indicating the relationship between this reported event and the subject device.
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Olympus medical systems corp.(omsc) received a literature title "ingenuity of esd procedure and treatment results for ulcerative colitis-related tumors".The literature reported the results of a study based on endoscopic submucosal dissection (esd) of 9 patients with ulcerative colitis between june, 2004 and september, 2019.During the study period, esd were performed with the use of the subject device (olympus single use electrosurgical knife), and an intraoperative perforation occurred in 1 patient and the procedure was abandoned.There is no description about the relationship between the subject device and adverse events, and no description about the severity or outcome of the adverse events.
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