Olympus reviewed the following literature titled "effect of mapping biopsy on surgical management of cholangiocarcinoma" by kojiro taura et al.This retrospective study aimed to evaluate the role of endoscopic transpapillary mapping biopsy (mb) in determining the surgical indication and procedure, and its effect on surgical radicality regarding the bile duct (bd) margin for cholangiocarcinoma (cca) patients.A total of 115 mb procedures were performed in 80 patients who underwent tumor resection.The study reported that 60 (75.0%) patients tolerated mb without any complications except pancreatitis observed in 20 (25.0%) patients.The incidence of bile leakage was significantly lower in the mb group in both the anastomotic site (5.0% vs.16.3%) and the parenchymal surface.The study concluded mb was safe and efficacious in selecting optimal surgical procedures for cholangiocarcinoma.The authors used multiple olympus devices and did not specify the devices used in relation to the adverse events experienced.Therefore, all olympus devices will be reported for the following adverse events: postoperatively, patients had mild, moderate and severe pancreatitis, post-hepactectomy liver failure, bile leakage at the anastomotic site, the parenchymal surface, and at a pancreatic fistula.This article includes 5 reports.(b)(6) - tjf-240.(b)(6) - tjf-260.(b)(6) - fb-45q-1.(b)(6) - e634044.(b)(6) - chf-b260.This is report 5 of 5 for: (b)(6) - chf-b260.
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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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