Olympus reviewed the following literature titled "a retrospective multicenter study comparing the punctures to b2 and b3 in endoscopic ultrasound¿guided hepaticogastrostomy".Objectives: in recent years,endoscopic ultrasound¿guided hepaticogastrostomy (eus¿hgs) has been performed as an important salvage option for failed endoscopic retrograde cholangiopancreatography for biliary drainage.However, technical issues, such as puncture site (bile duct of segment 3 [b3] or bile duct of segment 2 [b2]), dilation method, stent selection, and procedural safety, need to be resolved for the optimization of eus¿hgs.The present study was to compare the safety, difficulty, and technical and functional success between biliary access via b2 and b3 during eus¿hgs.Methods: we conducted a retrospective investigation of 161 consecutive eus¿hgs cases across a total of 6 facilities, including those at our hospital.The patients were divided into two groups according to the successful drainage route: the puncture to b2 (p-b2) or the puncture to b3 (p-b3).We compared the technical and functional success rates, technical difficulty, and adverse events between the two groups.We also conducted a subgroup analysis to show the factors related to the procedure time.Results: there were 92 cases in the p-b2 group and 69 cases in the p-b3 group.There were no significant differences in the technical success, functional success,or adverse events between the groups;however,the procedure time was significantly shorter in p-b2 cases than in p-b3 cases.The multivariate analysis showed that the puncture site was the only factor related to the procedure time.Conclusions: based on these findings, p-b2 appears useful and safe.P-b2 is as effective as p-b3 and was able to be performed in a shorter period of time.The b2 approach can be considered a useful option for eus¿hgs.Type of adverse events/number of patients: mediastinal emphysema (n=1).Sepsis (n=4).Ulceration (n=1).Bleeding (n=4).Peritonitis (n=6).Bile leakage (n=4).Pancreatitis (n=1).Stent slippage (n=3).Stent migration (n=1).Liver abscess (n=2).This literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6) (for gf-uct240-al5).2.(b)(6) (for gf-uct260).3.(b)(6) (for single use biliary drainage stent v).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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Since the literature described "gf-uct 240" and "a plastic stent (quickplace v 7-fr,11,15 cm;8.5-fr, 11, 15 cm)", we selected "gf-uct240-al5" and "pbd-v631p-0711j" as a representative product.The product was unknown but a representative product was chosen for processing purposes.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
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