Olympus TJF-Q180V Duodenoscope
The Olympus duodenoscope used at UCLA Medical Center went on the market in 2010. But according to Karen Riley, the deputy director of strategy at the FDA’s Office of External Affairs,Olympus never asked for FDA approval to put the device on the market.
- When did the FDA notice the egregious error? Either late 2013 or early 2014.
- Why didn’t the FDA notice? “I don’t know,” Riley told the media.
FDA regulations require any medical device maker to receive clearance if and when a new device model includes changes that could “significantly affect the safety and effectiveness of the device.” In the case of the Olympus TJF-Q180V duodenoscope, a modification to the elevator channel that was never cleared by the FDA was determined to be the exact part of the device implicated in the superbug cases. Olympus submitted an application to the FDA to sell the new model last year. Their FDA application is still pending.
At this time, it remains unknown whether the FDA will penalize Olympus for selling the model without their approval.
Olympus Medical Lawsuit
Olympus knew or should have known that endoscopic procedures using the device it designed and sold could result in contaminated fluids being transferred from patient to patient, according to lawsuits filed against the medical device manufacturer. Olympus made serious changes to the Q180V without evaluating the cleaning methods needed to disinfect the device after use. The company also failed to obtain FDA certification to sell the device. Without proper disinfection protocols, or a recall on the device to update safety information, Olympus knowingly put patients at serious risk, the lawsuits allege.
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If you believe that you were infected with superbug bacteria during an endoscopy procedure using either the Olympus, Fujifilm or Pentax duodenoscopes and would like more information about filing a lawsuit against one of these medical device manufacturers, please fill out our contact form or call us at (855) 948-5098 in order to speak with a medical device injury attorney.
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