Olympus reviewed the following literature: "randomized study of two endo-knives for the traction-assisted endoscopic submucosal dissection of early esophageal squamous cell carcinoma" by yoshiyasu kitagawa, et al.Abstract: needle-type devices, such as the dualknife (olympus, tokyo, japan), are widely used for traction-assisted esophageal endoscopic submucosal dissection (esd) but require a prolonged operation time.An improved model of the itknife (olympus), the itknife nano, may allow faster and easier esd than the dualknife.We conducted a randomized study to compare the performances of the dualknife and the itknife nano for traction-assisted esophageal esd.Patients with early esophageal squamous cell carcinoma were eligible for this study.The primary outcome was the total procedure time.The secondary outcomes were submucosal dissection time, en bloc, and complete resection rates, perforation rate, and adverse events.Results fifty patients were equally divided into two groups: the dualknife group (d-group) and the itknife nano group (i-group), and all underwent the assigned treatment.The i-group had significantly shorter total procedure time (36.8 vs.60.7 min; p < 0.01) and submucosal dissection time (17.2 vs.35.8 min; p < 0.01) than the d-group.The en bloc and complete resection rates were sufficiently high in both groups (100% and 100% in the d-group and 100% and 96% in the i-group, respectively).Significantly fewer hemostatic procedures due to intraoperative bleeding were performed in the i-group than in the d-group (0.2 vs.1.4; p < 0.01).Delayed bleeding, perforation, or esophageal stricture did not occur in either group.The itknife nano exhibited lower procedure time for traction-assisted esophageal esd than the dualknife, without increasing adverse events.Adverse events.Muscular layer exposure, n=7.The authors reporting using six (6) olympus devices during the study.This article includes 6 reports: (b)(6): (b)(4).(dualknife as the representative product).(b)(6): (b)(4).(b)(6): (b)(4).(b)(6): (b)(4).(b)(6): (b)(4).(b)(6): (b)(4).This report is 6 of 6: (b)(6): (b)(4).
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Additional information was provided by the author: in the opinion of the author, there was not a relationship between the olympus device and muscle layer exposure.The author reported no medical intervention was required.In addition, the authors defined muscle layer exposure as: when the fine texture of the muscle fibers of muscularis propria was clearly exposed and visible endoscopically, due to deep submucosal dissection.
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This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: b5, h6, h10.B1: no change in reportability.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.
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