( 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 did n'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 did n't we notice it ? I do n't know , '' Riley said . `` Can you imagine a prescription drug getting out on the market that did n'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 did n'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 . Seven hospital patients at Ronald Reagan UCLA Medical Center were infected with the deadly superbug CRE -- also known as carbapenem-resistant Enterobacteriaceae -- from October to January , according to hospital officials . Two of those patients died . The patients caught CRE after routine endoscopic treatments . Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak . The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria . Four other patients at Cedars-Sinai Medical Center in Los Angeles have also been infected with the superbug linked to a contaminated duodenoscope , according to a statement released by the hospital . The medical scope was used in all four patients , between August and January 2015 . Sixty-four other patients who had a duodenoscope procedure with that particular scope are being informed by mail , `` out of an abundance of caution . '' According to FDA rules , a manufacturer must seek clearance for a new model if it includes changes that `` could significantly affect the safety or effectiveness of the device . '' The TJF-Q180V duodenoscope , used to check out ducts in the gastrointestinal system , includes a modification to the exact part of the device that 's been implicated in the superbug outbreaks . With this new model , Olympus sealed up that part of the device , known as the elevator channel , hoping to make it more impervious to infection . `` The company clearly made these modifications to make the device safer , but it seems to be that it was n't safer , '' Riley said . Last year , at the FDA 's request , Olympus applied for permission to sell the scope . That application is still pending . Riley emphasized that duodenoscope procedures can be lifesaving , so the agency does n't want to take them off the market . `` More than 500,000 of these procedures are done every year in the U.S. , and the risk of bacterial transmission is actually really very , very low , '' she said . `` We believe the benefits outweigh the risks . '' In its statement , Olympus wrote : `` The emergence of drug-resistant microorganisms is a challenge to the entire health care community . Olympus is working with relevant medical societies and our customers in research of this emerging issue and the development of additional safeguards to prevent infection associated with [ duodenoscope procedures ] . '' Riley noted that the other two duodenoscope manufacturers , Pentax and Fujifilm , did apply for and were granted clearance to market models similar to Olympus ' TJF-Q180V . Now the FDA is asking all three companies to submit evidence that the scopes can be thoroughly cleaned -- and so far it 's not going well . Riley said twice the companies have submitted data that failed to show that cleaning could get rid of 99.9999 % of all microbes on the scope -- the FDA 's standard for disinfection . `` We 're still working with them to get good data , '' she said . Riley said she does n't know if the FDA will penalize Olympus for selling the device without permission . Diana Zuckerman , a device safety expert , said they should . `` It 's like with kids . How do you teach your children to behave if there are no consequences when they misbehave ? '' she said .
FDA official says Olympus never got permission to sell its endoscope . The company has been under investigation for selling a device that can be used in the United States without an FDA-approved prescription and is not covered by insurance plans.