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FDA Clears Redesigned Olympus Duodenoscope As Olympus Readies To Replace Old Scopes

This article was originally published in The Gray Sheet

Executive Summary

FDA cleared a redesign of Olympus America’s TJF-Q180V duodenoscope, and new labeling, as the company prepared to replace the old devices at health care facilities. The changes are intended to “help reduce the risk of bacterial infections” from TJF-Q180V, implicated in three years of carbapenem-resistant Enterobacteriaceae outbreaks that sickened and killed hundreds of patients here and abroad.

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