Olympus reviewed the following literature titled: "management of gastrointestinal subepithelial tumors with endoscopic resection." this study was conducted to explain the management of gastrointestinal subepithelial tumors (gi sets) and resecting gi sets with endoscopic submucosal dissection (esd) and submucosal tunneling endoscopic resection (ster) to explore the efficacy of this technique.A total of 39 patients were involved in this study.Out of them 36 were resected by esd and 3 were resected by ster.The surgical methods esd and ster were conducted using the device endoscope gifq260j, distal hood d-201-11 304, electrocoagulation unit esg 100, dual knife, dual knife j, it knife nano and other devices.The mean tumor size was 16.8 ± 1.3 mm.The overall procedural time was 37.9 ± 4.6 minutes.Complications like perforations were observed in three patients.The study concluded that esd and ster can be an effective modality for the diagnosis and management of gi sets in a selected group of patients.The authors reported mild pain after esd, unspecified bleeding and unspecified infection.The reportable events identified by the author are: perforation -(n=3).Subcutaneous emphysema -(n=unknown).Multiple olympus devices were used in this study and the authors did not specify which device was being used at the time of the adverse events.Therefore, all will be reported as follows: patient identifier (b)(6): gif-q260j, gastroscope.Patient identifier (b)(6): d-201-11304, distal attachment.Patient identifier (b)(6): esg-100 (wb991046).Patient identifier (b)(6): kd-612u, it knife nano.Patient identifier (b)(6): kd-655u, dual knife j.This report is 4 of 5 for patient identifier (b)(6): kd-612u, it knife nano.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and from the author.New information was added to the following fields: b3, b5, h6, h10.The device history record was unable to be reviewed for this device since the 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.Olympus will continue to monitor field performance for this device.
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