FDA Clears Olympus TJF-Q190V Duodenoscope With Disposable Endcap

Olympus received FDA clearance for its TJF-Q190V duodenoscope that features a single-use endcap and novel flushing adapter that reduce the chance for pathogens to settle between cases. Olympus touts that the new device has a large field of view, a reliable guidewire locking system, and precise handling.

Duodenoscopes are used to perform endoscopic retrograde cholangiopancreatography (ERCP) procedures as an option over open surgery. A few years ago duodenoscopes were identified as carriers of infections, due to flawed design and insufficient processing, and even led to a number of patient deaths. The industry had to reinvent itself and the devices it makes, resulting in a recent slew of approvals of new duodenoscopes and supporting devices that resolve the problem of disease transmission (see flashbacks below).

To guarantee that the new endoscope performs as expected, Olympus will conduct regular inspections and routine maintenance of every TJF-Q190V based on how often it is reprocessed. This can help ensure that regular usage will not make the device more welcoming to pathogens or that reprocessing effectiveness is reduced.

“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,” said Kurt Heine, Group Vice President for Endoscopy at Olympus America Inc., in a press release.

“A goal of our innovation is to expand the capabilities of our physician customers, while making it easier to achieve patient safety standards,” added 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.”

Here are some of the features of the new device, according to Olympus:

  • 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.

Product page: TJF-Q190V duodenoscope…

Flashbacks: FDA Clears First Completely Disposable Duodenoscope; FDA Clears First Duodenoscope with Disposable Business End; PENTAX Medical’s DEC HD Partially Disposable Duodenoscope FDA Cleared; ScopeSeal, A Snap-on Shield to Keep Duodenoscopes Clean from Infections

Via: Olympus