Olympus reviewed the following literature: "prognosis of rectal neuroendocrine tumors after endoscopic resection: a single-center retrospective study" by yue zheng, kehang guo1, and ruijie zeng et al.The study was aimed to investigate the efficacy and outcomes of different types of endoscopic resection in patients with rectal neuroendocrine tumors (nets), by analyzing the tumor morphology along with the rates of complete resection, complications, and outcomes.A total of 98 patients with rectal nets were included to evaluate the en bloc resection rate and histopathological complete resection rate (h-cr) of the lesions.And also investigated for complications such as; postoperative perforation and delayed postoperative hemorrhage.The study reported the en bloc resection rate of the modified endoscopic mucosal resection (emr) and endoscopic submucosal dissection (esd) treatment groups was 97.2% (35/36) and 100% (62/62), respectively.No adverse events except one delayed postoperative hemorrhage and no tumor recurrence or tumor-related death occurred.Modified emr and esd were concluded as safe and effective endoscopic approaches for the resection of rectal nets =15 mm in diameter.However, the study warranted a comprehensive preoperative evaluation of risk factors including, the depth of tumor invasion and tumor diameter for endoscopic resection.The authors used multiple olympus devices and reported the following adverse event: delayed postoperative hemorrhage: one patient experienced a delayed postoperative hemorrhage, which was successfully controlled after endoscopic interventions.Delayed postoperative hemorrhage refers to a hemorrhage that cannot spontaneously stop within 24 h after endoscopic resection and requires additional clinical interventions.Patient identifier (b)(6): kd-650l; patient identifier (b)(6): gif-q260j ; patient identifier (b)(6): gif-q260; patient identifier (b)(6): kd-610l.This report is 1 of 4 for patient identifier (b)(6): kd-650l.
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Additional information was received from the author: only one patient had bleeding, and the operation was prolonged.At that time, hemostatic clips were used for treatment, and no harm was caused to the patient, and the patient has recovered.The author also reported his medical opinion and does not think the adverse event was caused by the olympus device.
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This supplemental report is being submitted to provide the author's response and the results of the legal manufacturer¿s investigation.New information added to b5, h6, and h10.Device history records review was not performed since the serial number was not provided.Olympus ships product manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.
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