article_snippet: (CNN)CNN has learned that the manufacturer of the endoscope involved in two superbug deaths at UCLA never obtained permission to sell Medical device, according to an official at the Food and Drug Administration.
article_snippet: Olympus started selling Olympus TJF-Q180V duodenoscope in 2010, but FDA didn't notice until late 2013 or early 2014 that Olympus had never asked for clearance to put it on the market, according to Riley.
article_snippet: In a statement, Olympus said Olympus didn't think needed FDAFDA's permission to sell the device, but now at the request of the agency, Olympus has applied for the FDA's permission to sell the device.
article_snippet: With this new model, Olympus sealed up that part of the device, known as the elevator channel, hoping to make the device more impervious to infection.
article_snippet: Olympus clearly made these modifications to make the device safer, but the device seems to be that the device wasn't safer," Riley said.
article_snippet: Last year, at FDA's request, Olympus applied for permission to sell the scope.
article_snippet: Olympus is working with relevant medical societies and Olympus customers in research of this emerging issue and the development of additional safeguards to prevent infection associated with Riley Riley noted that the other two duodenoscope manufacturers, Pentax and Fujifilm, did apply for and were granted clearance to market models similar to
article_snippet: Riley said Riley doesn't know if the FDA the FDA will penalize Olympus for selling the device without permission.
highlights_snippet: FDA official says Olympus never got permission to sell Olympus endoscope .
  