First Duodenoscope with Disposable Distal Cap Cleared by FDA

The FDA issued an alert in January concerning a design issue with a previous version of the Pentax ED-3490TK
The FDA issued an alert in January concerning a design issue with a previous version of the Pentax ED-3490TK

The Food and Drug Administration (FDA) has cleared Pentax ED34-i10T, the first duodenoscope with a disposable distal cap. 

The Pentax ED34-i10T duodenoscope is intended to provide visualization and access to the upper gastrointestinal tract (GI) to treat bile duct disorders and other upper GI problems.

Flexible lighted duodenoscopes are threaded through the mouth into the top of the small intestine. Its many small parts can pose difficulty when cleaning. If not properly cleaned and disinfected, the complex device can hold contaminated tissue or fluid in its crevices, increasing the risk of infection between patients. 

With a disposable distal cap, the chance of transmitting infections between patients is decreased. The FDA had alerted health care providers in January about a design issue with a previous version, the Pentax ED-3490TK, regarding the potential for cracks and gaps to develop in the adhesive that seals the duodenoscope's distal cap onto the scope. 

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The new Pentax ED34-i10T features a single-use detachable and disposable distal cap with a simpler user interface. It also features enhanced ergonomics, image quality, and is a shorter length. 

“Improving the safety of duodenoscopes is a top priority for the FDA, and we encourage companies to continue to pursue innovations that will help reduce the risk to patients,” said William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA.

For more information visit FDA.gov.