Olympus Recall OF All TJF-Q180V Duodenoscopes
The FDA approved a modified design of the Olympus Company’s duodenoscope. The Company’s duodenoscopes have been associated with numerous serious side effects, including causing antibiotic resistant superbug infections which can cause serious health issues or death.
Because of the recent FDA approval of the modified design, Olympus will now recall all of its current design (approximately 4,400) of the TJF-Q180V model duodenoscopes, which are in use throughout the country.
The hope is that the new designs will be more impervious and resistant to contamination and therefore patients will develop fewer infections.
On March 4, 2015, the FDA provided Updated Information for Health care Providers Regarding Duodenoscopes. At that time, Olympus had a pending 510(k) application for its TJF-Q180V duodenoscope. The company continued to market this device while its application was under review. On January 15, 2016, the FDA cleared the TJF-Q180V duodenoscope 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
Includes information about the TJF-Q180V duodenoscope’s design and labeling changes per the cleared 510(k);
Outlines Olympus’ strategy to repair all customers’ TJF-Q180V elevator mechanism in accordance with the new design; and
Informs customers that Olympus will set up a return schedule with them for duodenoscope repair.
“We have made it a top priority to improve the safety of duodenoscopes and help protect patients from bacterial infections associated with these medical devices,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Olympus TJF-Q180V’s new design, as well as the new annual inspection program, is 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.”