Olympus reviewed the following literature article: "propensity score matching analysis to evaluate efficacy of polyethylene oxide adhesive on preventing delayed bleeding after gastric endoscopic submucosal dissection" by yang yu, et al. regardless of technical advancements, delayed bleeding is still a common adverse event after gastric endoscopic submucosal dissection (esd), often occurring in the early postoperative phase.This study aimed to evaluate the efficacy of a newly designed polyethylene oxide (peo) adhesive for preventing delayed gastric bleeding.Patients who underwent gastric esd between (b)(6) 2017 and (b)(6) 2020 at three chinese institutions were retrospectively reviewed.Patients receiving peo application on gastric post-esd ulcers were included in the peo group, and patients without this procedure were included in the control group.To minimize potential bias, propensity score matching was performed, and sex, age, lesion size, lesion morphology, ulceration, localization, procedure time, frequency of major intraoperative bleeding, resected specimen size, lesion histopathology, submucosal invasion and the taking of antithrombotic drugs were included as matching factors.The incidence of delayed bleeding and time to bleeding were compared between both groups.After propensity score matching, 270 patients (135 per group) were included in the analysis.The delayed bleeding rate in the peo group was significantly lower than that in the control group (1.5%, 2/135 vs.8.9%, 12/135, p= 0.006).The median time (range) to bleeding was 4.5 (4¿5) days in the peo group and 2 (1¿15) days in the control group, with no significant difference (p= 0.198).Peo demonstrated a significant effect in reducing the rate of delayed bleeding.Further study is warranted to confirm the efficacy of peo for bleeding that occurs in the early phase after gastric esd.Adverse events: n = 1 experienced haemorrhagic shock on pod1 with transient tachycardia and hypotension, and he also received a blood transfusion because of a decrease in haemoglobin from 101 to 62 g/l.After endoscopic haemostasis and conventional medical treatment, the patient¿s condition stabilized on the same day, and he was discharged on.N = >14 - for patients with delayed bleeding, endoscopic haemostasis was successfully performed primarily with electrocoagulation for all bleeding sites.Metal clips were used as combined therapy for 5 lesions.Immediate haemostasis was achieved in all cases, and no re-bleeding events occurred later.N= 4: major intraoperative bleeding was arteriolar bleeding or diffuse venous bleeding in which haemorrhagic sites could not be located for the first time.The article includes 6 reports: patient identifier (b)(6): kd-650u.Patient identifier (b)(6): gif-hq290.Patient identifier (b)(6): ucr.Patient identifier (b)(6): fd-411ur.Patient identifier (b)(6): nm-200l-0423.Patient identifier (b)(6): gif-q260j.This report is 1 of 6 for patient identifier (b)(6): kd-650u.
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Additional information received from the author: the author stated the olympus device did not cause or contribute to the adverse events reported.He also reported: the image blurring during the operation had nothing to do with our machine.The haemostatic powder used in the literature was sticky, which stuck to the ccd glass of our endoscope during esd surgery, causing temporary image blurring.These problems were determined by the haemostatic powder provided by other manufacturers.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.Additional information added to b3 and g2.Olympus will continue to monitor field performance for this device.
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