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 "comparison between submucosal tunneling endoscopic resection and video-assisted thoracoscopic enucleation for esophageal submucosal tumors originating from the muscularis propria layer: a randomized controlled trial".The literature reported the results of a study based on submucosal tunneling endoscopic resection (ster) or video-assisted thoracoscopic enucleation (vate) of 66 patients with small esophageal submucosal tumors between july, 2014 to december, 2015.During the study period, ster were performed with the use of the subject device (olympus insufflator: ucr), and subcutaneous or mediastinal emphysem occurred in 3 patient.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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