FDA Clears A Duodenoscope with a Detachable Cap Almost 20 years ago, the FDA cleared two other duodenoscope models with a reusable distal cover for sale in the U.S.

Sept. 25, 2017 (Monday; 11:47am) — The FDA announced last week that it has “cleared the first duodenoscope with a disposable distal cap” for use in U.S. hospitals, calling this a “new feature.” According to the FDA’s press release issued last Wednesday, the...

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The Redesigned Olympus Duodenoscope Has Been Linked to a ‘Superbug’ Cluster. The device's original design was recalled in January 2016 amid concerns about its safety.

March 21, 2017 (9:58 pm ET) — A “corrected” duodenoscope design introduced last year by the manufacturer to replace a recalled device has been linked to a “superbug” cluster, I have learned. The recalled duodenoscope had been a focus of the FDA in...

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Infections Are Not Limited to the LivaNova’s Sorin 3T Heater-Cooler or to M. chimaera

January 18, 2017 — More than one brand of a specialized type of medical equipment used during open-chest surgery has been linked to potentially life-threatening bacterial infections, my research has found. In all, as many as one million U.S. patients since 2011 who...

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