Expiration date - unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacturer date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the product release decision control sheet of the involved product code/lot# combination over the past three years (november 2018 to october 2021) confirmed that there were not any indications of anomaly in them.Review of the manufacturing record and the product release decision control sheet of the involved product code/lot# combination over the past three years (november 2018 to october 2021) confirmed that there were not any indications of anomaly in them.Review of the safety test result over the past three years confirmed that there were not any indications of anomaly in them.This product has undergone iso10993 compliant biological safety evaluation (cytotoxicity, skin sensitization, intracutaneous reaction, acute toxicity, pyrogen, hemolysis) at the product design stage.Safety test: in (b)(4) factory, the safety test is performed on a regular basis.Indicator bacteria test (iso 11135).Endotoxinic test (jp standard).Extraction test (disposable set standard for oxygenator).Residual eo, ech test (iso10993-7).It could not clarify the causal relationship with the involved product and could not identify the cause of occurrence.(b)(4).
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An article was published in an american scholarly journal (plosone).It was about a retrospective analysis of a total of 85 patients who underwent endoscopic retrograde cholangiopancreatography (ercp) and endoscopic ultrasound (eus) for suspected biliary stenosis at the samsung medical center in south korea.In that article, it was reported that there was post-procedure acute pancreatitis as adverse events.Since visiglide was included in the device used, it was taken up as compliments by our us subsidiary.However, there was no mention of the relationship between adverse events and visiglide, and there was no report of device malfunction.
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