Olympus reviewed the following literature: permanent endoscopic gallbladder stenting versus removal of gallbladder drainage,long-term outcomes after management of acute cholecystitis in high-risk surgical patients for cholecystectomy:multi-center retrospective cohort study" by a.Maruta, t.Iwashita, and keisuke iwata et al. endoscopic transpapillary gallbladder drainage (egbd) has been reported as an effective gallbladder drainage treatment option for acute cholecystitis in high-risk surgical patients.However, the long-term outcomes such as cholecystitis' recurrence rate after placement of egb stenting (egbs) have not been well studied yet.The authors used 3 olympus devices and did not specify the adverse events in relation to the devices and therefore, the adverse events will be reported for all olympus devices (b)(6): kd-v411m-0725.(b)(6): kd-211q-0725.Complaint 3 visiglide2.1 - pancreatitis.1 - cystic duct injury, managed conservatively.3 - bile peritonitis, managed conservatively.Late adverse events (6 months and 1 year).22 - cholecystitis reoccurrence.11 -common bile duct stones.3 - common bile duct stones and reoccurrence of cholecystitis.This is report 2 of 3 for (b)(6): kd-211q-0725.
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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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