Olympus reviewed the following literature article: "biliary guidewire facilitates bile duct biopsy and endoscopic drainage" by toshihiko higashizawa, et al.The study investigated the introduction of a guidewire through bile duct strictures and across the biliary stenosis to find out if that facilitates the transpapillary bile duct biopsy and subsequent biliary drainage.Transpapillary bile duct biopsy was attempted in 61 consecutive cases, with extrahepatic or intrahepatic bile duct strictures detected by endoscopic retrograde cholangiopancreatography (ercp).The study evaluated the success rate of endoscopic biliary drainage after performing bile duct biopsy and complications.In conclusion, the study said that the patients with bile duct strictures at ercp, the placement of a guidewire facilitates the insertion of biopsy forceps and subsequent endoscopic biliary drainage, and the biopsies were positive for cancer are more likely with bile duct cancer than pancreatic cancer.One patient suffered from acute pancreatitis that resolved within 48 h after treatment with analgesia and intravenous fluids.The authors reported using 3 different olympus devices and did not specify the olympus device used in relation to the adverse event and therefore, all will be reported.(b)(6) is for jf-230; (b)(6) is for jf-200; (b)(6) is for fb-39q-1.This is report 2 of 3 for (b)(6) is for jf-200.
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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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