Olympus reviewed the following literature titled "the risk scoring system for assessing the technical difficulty of endoscopic submucosal dissection in cases of remnant gastric cancer after distal gastrectomy".¿literature summary¿ this study aimed to develop and validate a risk-scoring system for assessing the technical difficulty of endoscopic submucosal dissection (esd) for remnant gastric cancer (rgc) after distal gastrectomy (dg) in a large multicenter cohort.A risk-scoring system for the technical difficulty of the procedure was developed based on multiple logistic regression analyses, and its performance was internally validated using bootstrapping.A total of 197 consecutive patients with 201 lesions were analyzed.There were 90 and 111 difficult and non-difficult cases, respectively.The scoring model consisted of four independent risk factors and points of risk scores were assigned for each as follows: tumor size > 20 mm: 2 points; anastomosis site: 2 points; suture line: 1 point; and non-expert endoscopist: 2 points.The c-statistics of the scoring system for technical difficulty was 0.72.The study developed a validated risk-scoring model for predicting the technical difficulty of esd for rgc after dg that can contribute to its safer and more reliable performance.¿type of adverse events/number of patients¿ intraoperative perforations -(15) delayed perforation -(4) intraoperative bleeding -(1) delayed bleeding -(9) the authors used two olympus devices and did not specify which device was being used with the patients with adverse events.Therefore, both will be reported as follows: (b)(6): d-201-11804 as representative model for transparent hood (b)(6): kd-611l , it knife this report is 1 of 2 for (b)(5): d-201-11804 as representative model for transparent hood.
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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 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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