Olympus reviewed the following literature article: "correlation between endoscopic resection outcomes and endosonographic findings in gastric tumors with muscularis propria origin." literature summary: this study was aimed to determine the correlation between endoscopic resection outcomes and endosonographic findings in gastric tumors with muscularis propria origin.Total 32 patients were included; tumors located in submucosa (group i, n=5), muscularis propria (group ii, n=14), and tumors extended into the outer cavity (group iii, n=13).In total, four patients experienced perforation which occurred in one patient in group i, one patient in group ii, and two patients in group iii and local recurrence occurred in two patients with incomplete emd resections.This study concluded that preprocedural eus predicted the layer of the tumor accurately; however, it was limited in the evaluation of the pattern of invasion.They found that tumors that were diagnosed as growing outward on eus rarely penetrated the muscularis propria and invaded the subserosal layer upon pathological examination.Eus has the limitations to evaluate the invasion patterns of tumors using eus.Type of adverse events/number of patients: [group i] perforation - 1 patient [group ii] perforation - 1 patient [group iii] perforation - 2 patients local recurrence - 2 patients hx-610-090l was selected for the olympus clips since they were shipped the most in the area and in the study period it-knife kd-610l was selected to represent one of the following devices used: it-knife, it knife-2, or hook knife this article includes 2 reports: (b)(6): hx-610-090l.(b)(6): kd-610l.This report is 1 of 2 for (b)(4): hx-610-090l.
|
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.Olympus will continue to monitor field performance for this device.
|