FDA: Manufacturer never had permission to sell device connected to superbug deathsCNN)CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell the device, according to an official at the Food and Drug Administration.
Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs.
"Why didn't we notice it? I don't know," Riley said.
Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn't notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA's Office of External Affairs.
"Why didn't we notice it? I don't know," Riley said.