Olympus is issuing a voluntary recall of its TJF-Q180V duodenoscope following a Senate committee report alleging that the company knew of the deadly design flaw that resulted in the deaths of some patients.
The design flaw, which made the scope nearly impossible to disinfect between patients, allegedly resulted in the deaths of patients who contracted deadly infections from the scopes.
The Los Angeles Times reports that the company’s duodenoscopes account for roughly 85 percent of the scopes sold in the United States.
The U.S. Food and Drug Administration cleared the scope in question on January 15, the TJF-Q180V, in light of design modifications and new labeling “intended to help reduce the risk of bacterial infections.”
According to the FDA’s announcement, the company is to voluntarily recall the original model of the scope and to make the necessary changes “as quickly as possible.”
William Maisel, M.D., M.P.H, the chief scientist and deputy director for science at the FDA’s Center for Devices and Radiological Health, indicated in a statement that the scope’s new design and new annual inspection program are “intended to reduce the risk of fluid leakage into the elevator channel, which in turn can reduce patient exposure to bacteria and other potential infections.
The model in question first came under FDA fire back in March of 2014 when the administration notified the company that their “closed” elevator channel model, which was “open” in prior models, required the submission of a premarket notification. The administration notified the company in a letter that the design changes had significant health implications as they impacted the safe use of the device.
In order to resolve the issue, the company has reverted to a mechanism design that, according to the FDA, “is substantially equivalent” to the previously approved mechanisms contained within the company’s duodenoscopes that previously received FDA approval.