Category: Device Recalls

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

Updated guidance is provided to reduce the risks of mucosal injuries and the endcap becoming detached and falling off inside the patient when using a duodenoscope with a single-use endcap.

A Bronchoscope is Linked Again in the U.S. to an Outbreak of the Feared ‘CRE’ Superbug Is enough being done to improve safety? The recall of several bronchoscope models is also discussed.

October 1, 2018 (updated: Oct. 5, 2018; edited: Oct. 8, 2020) — A bronchoscope’s use has been linked again to a “superbug” outbreak, this time involving “multiple patients,” according to…

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…