Category: Medical Device Reports (MDRs)

A Duodenoscope Has Been Linked to ‘Probable Transmission’ of a Colistin-Resistant Superbug In January, the FDA had issued a safety alert reporting a "design issue" with the endoscope "that could increase the risk of patient infection."

December 8, 2017 (2:46 pm) — A duodenoscope has been linked, possibly for the first time, to the “probable transmission” of a uniquely resistant type of superbug, I have learned.…

Deadly Infections at a South Carolina Hospital in 2014: Was A Heater-Cooler Device To Blame? Previously undisclosed data confirm a direct association between the infections and a contaminated heater-cooler device.

February 18, 2016 — A type of medical device recently linked to serious patient infections may have played a more significant role in a deadly hospital outbreak in South Carolina…