FDA clears new generation duodenoscope

CENTER VALLEY: FDA has granted clearance to new generation duodenoscope TJF-Q190V with a sterile, disposable distal endcap. This newest generation of Olympus duodenoscope incorporates innovative features designed to improve the cleaning and reprocessing of the duodenoscope, thereby helping to reduce potential device contamination. The TJF-Q190V duodenoscope responds to the FDA's call for duodenoscopes with disposable components that improve access to the elevator mechanism for ease of reprocessing.

Duodenoscope with sterile, disposable endcap Improves ease of reprocessing while offering advanced features for improved clinical performance.

Olympus Announces FDA 510(k) Clearance of the TJF-Q190V Duodenoscope with Sterile, Disposable Distal Endcap and Proprietary Flushing Adapter, Designed to Improve the Ease of Reprocessing

Olympus Announces FDA 510(k) Clearance of the TJF-Q190V Duodenoscope with Sterile, Disposable Distal Endcap and Proprietary Flushing Adapter, Designed to Improve the Ease of Reprocessing

The innovative features designed to improve cleaning and reprocessing, which are based on findings of human factors studies, include:

Use of a sterile, clear, single-use distal endcap cover that is removed and discarded post-procedure. This design prevents the possibility of reuse.

Improved visualization of and access to the distal end for manual cleaning and disinfection.

A first-of-its-kind, proprietary distal-end flushing adaptor for cleaning the elevator mechanism.

A sealed elevator wire channel port that does not require separate cleaning.

A new water-resistant scope connector that minimizes the risk of fluid ingress.

Olympus will perform periodic inspection and maintenance of every TJF-Q190V based on frequency of reprocessing, to better ensure that normal wear and tear does not compromise the functionality of the duodenoscope or the ability to properly reprocess the duodenoscope.

Finally, the TJF-Q190V duodenoscope addresses the clinical needs of physicians. Recent statements from medical societies regarding duodenoscope reprocessing and infection control clearly reinforce the need to be able to offer the potentially lifesaving ERCP (endoscopic retrograde cholangiopancreatography) procedure to treat seriously ill patients, rather than more invasive options, such as surgery. The performance of the duodenoscope is critical to reaching difficult-to-access digestive system anatomy. The advanced features of the TJF-Q190V include an expanded field of view, reliable guidewire locking, and more precise handling.

"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 with the most advanced tools and technology for accurate and effective diagnosis and treatment," said Kurt Heine, Group Vice President for Endoscopy at Olympus America Inc.

"A goal of our innovation is to expand the capabilities of our physician customers while making it easier to achieve patient safety standards," said Dr Ross Segan, Chief Medical Safety Officer at Olympus Corporation of the Americas. "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."

For more information, please call 1-800-848-9024 or visit us at http://medical.olympusamerica.com.