Olympus reviewed the following literature literature titled "endoscopic submucosal dissection for superficial pharyngeal carcinoma is effective and safe".Literature summary: this study was aimed to evaluate retrospectively the outcomes of endoscopic submucosal dissection (esd) for superficial pharyngeal carcinomas.A total 27 patients with 30 lesions were treated by esd in this study.The en-bloc and complete resection rates were respectively 100% and 93.3%.No bleeding, perforation, or dyspnea during or after the esd procedure occurred.There was 1 patient who had post-procedure related pharyngeal edema and cellulitis.This patient was managed with subsequent conservative treatment, including fasting, sterane, and intravenous antibiotics.This study concluded that esd is effective and safe for resection of superficial carcinomas at the pharynx, with a high complete resection rate and favorable outcomes.Type of adverse events/number of patients: pharyngeal edema (cellulitis) - 1 patient.This article includes three (3) reports: (b)(6)/kd-650q, (b)(6)/gif-q260, (b)(6)/gif-h290.This report is 1 of 3 (b)(6)/kd-650q.
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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.This supplemental report includes information added to b5 and g2.Olympus will continue to monitor field performance for this device.
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