Olympus reviewed the following literature titled, "usefulness of the combined orthodontic rubber band and clip method for gastric endoscopic submucosal dissection." background and aims: effective traction is an important prerequisite for successful endoscopic submucosal dissection (esd).The combined orthodontic rubber band (orb) and clip method was effective in colorectal cancer esd.To date, the method was not reported in gastric esd.This study aimed to investigate its effcacy and safety for gastric neoplasms esd.Methods: we retrospectively analyzed data of 118 patients with gastric neoplasms treated by esd from november 2020 to april 2022, 43 by orb-esd and 75 by the conventional esd.The primary outcome measure was the esd procedure time.Clinical data on efficacy and safety were also collected and analyzed.Propensity score matching (psm) matched the patients in both groups.Results: psm successfully matched 31 pairs of patients.The orb-esd operation time was shorter (median [interquartile range], 35 [30¿48] vs.49 [40¿70] min, p0.05).Conclusions: compared to the conventional esd, orb-esd significantly reduced the procedure time and increased the dissection speed, proving beneficial to gastric esd.Type of adverse events/number of patients: [orb-esd group] delayed bleeding - 1 patient, [conventional esd] delayed bleeding - 3 patients.This literature article requires 4 reports.The related patient identifiers are as follows: (b)(6) (nm-4u-1).(b)(6) (kd-650l).(b)(6) (fd-410lr).(b)(6) (gif-q260j).This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
|
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.
|