Story highlights FDA official says Olympus never got permission to sell its endoscope

Medical device is connected to CRE outbreak in California that's left two people dead

(CNN) 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.

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"Can you imagine a prescription drug getting out on the market that didn't go through the approval process?" asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who's testified to Congress about device safety problems. "Devices need to be regulated more vigorously. This is really disturbing."

In a statement, Olympus said it didn't think needed the FDA's permission to sell the device, but now at the request of the agency, it has applied for that permission. That application is still pending.

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