Olympus reviewed the following literature titled "endoscopic submucosal dissection for large duodenal laterally spreading lesions is feasible: a multi-center retrospective study".This multicentric retrospective study sought to assess the effect and safety of esd for large laterally spreading lesions located in the descending duodenum based on multi-center experiences.A total of 51 patients were included.The average procedure time for en bloc resection ranging from 20 to 117 min (median: 45.5 min).Two patients experienced delayed bleeding 3 days after esd and 2 other patients were diagnosed with delayed perforation.All the patients were closely followed up for a median period of 16 months (range 7 to 29 months), and there were no deaths.No residual tumor and local recurrence occurred during follow-up.Esd for laterally spreading lesions of the descending duodenum is a feasible therapeutic procedure and can achieve a favorable en bloc resection rate.Type of adverse events/number of patients: delayed bleeding: case 1.Delayed bleeding: case 2.Delayed perforation (postoperative fever, mild abdominal pain): case 3.Delayed perforation (fever, severe abdominal pain, diffuse peritonitis): case 4.This literature article requires 28 reports.The related patient identifiers are as follows: 1.(b)(6)/case1(female, 64)/kd-620lr; 2.(b)(6)/case1(female, 64)/kd-611l; 3.(b)(6)/case1(female, 64)/fg-8u-1; 4.(b)(6)/case1(female, 64)/nm-4l-1; 5.(b)(6)/case1(female, 64)/fd-410lr; 6.(b)(6)/case1(female, 64)/gif-h260; 7.(b)(6)/case1(female, 64)/maj-339; 8.(b)(6)/case2(male, 63)/kd-620lr; 9.(b)(6)/case2(male, 63)/kd-611l; 10.(b)(6)/case2(male, 63)/fg-8u-1; 11.(b)(6)/case2(male, 63)/nm-4l-1; 12.(b)(6)/case2(male, 63)/fd-410lr; 13.(b)(6)/case2(male, 63)/gif-h260; 14.(b)(6)/case2(male, 63)/maj-339; 15.(b)(6)/case3(male, 57)/kd-620lr; 16.(b)(6)/case3(male, 57)/kd-611l; 17.(b)(6)/case3(male, 57)/fg-8u-1; 18.(b)(6)/case3(male, 57)/nm-4l-1; 19.(b)(6)/case3(male, 57)/fd-410lr; 20.(b)(6)/case3(male, 57)/gif-h260; 21.(b)(6)/case3(male, 57)/maj-339; 22.(b)(6)/case4(female, 61)/kd-620lr; 23.(b)(6)/case4(female, 61)/kd-611l; 24.(b)(6)/case4(female, 61)/fg-8u-1; 25.(b)(6)/case4(female, 61)/nm-4l-1; 26.(b)(6)/case4(female, 61)/fd-410lr; 27.(b)(6)/case4(female, 61)/gif-h260; 28.(b)(6)/case4(female, 61)/maj-339.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.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and follow-up from the author.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 events 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.
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