Olympus secures FDA approval for TJF-Q190V Duodenoscope

3 February 2020 (Last Updated February 3rd, 2020 10:07)

Medical and surgical solutions provider Olympus has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its TJF-Q190V duodenoscope.

Olympus secures FDA approval for TJF-Q190V Duodenoscope
Olympus Announces FDA 510(k) Clearance of the TJF-Q190V Duodenoscope. Credit: © 2020 Olympus America.

Medical and surgical solutions provider Olympus has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its TJF-Q190V duodenoscope.

The US agency approved the TJF-Q190V duodenoscope with a sterile and disposable distal endcap, designed to reduce contamination and improve reprocessing of the device.

The distal endcap on the device is for single usage, discarded following the procedure.

TJF-Q190V Duodenoscope features a distal-end flushing adaptor for cleaning the elevator mechanism.

It also comes with a sealed elevator wire channel port and a water-resistant scope connector to reduce fluid ingress risks.

Additionally, the TJF-Q190V duodenoscope offers an expanded field of view and better handing to carry out endoscopic retrograde cholangiopancreatography (ERCP) on severely sick patients, instead of opting for more invasive procedures.

Olympus America Endoscopy group vice-president Kurt Heine said: “Infection prevention is an ongoing mission that we at Olympus are committed to fulfilling, working in partnership with our customers, medical societies, and regulatory authorities to keep patients safe while providing physicians the most advanced tools and technology for accurate and effective diagnosis and treatment.”

The company also notes that it will carry out periodic assessment and maintenance of all TJF-Q190V to optimise the functionality of the duodenoscope.

Olympus Corporation of the Americas chief medical safety officer Dr Ross Segan said: “A goal of our innovation is to expand the capabilities of our physician customers while making it easier to achieve patient safety standards.

“The further into the body we can go with minimally invasive equipment, the more power we will have to diagnose life-threatening conditions and treat them, which can lead to critical benefits, including reduced costs and improved patient outcomes and satisfaction.”

Last September, Olympus introduced two new rhino-laryngoscopes with video capability to ensure better visualisation during ENT procedures.