J A N U A R Y 2 0 1 7 • O U T PA T I E N TS U R G E R Y. N E T • 2
First Duodenoscope With Detachable Distal Cap
The FDA last month granted Pentax of America clearance of the
ED34-i10T, the first duodenoscope with a detachable and disposable
distal cap, a new feature the agency says will improve access for
cleaning and reprocessing and lower the risk of future infections
associated with duodenoscopes. An earlier version of the Pentax
duodenoscope, the ED-3490TK, had the potential for cracks and gaps
to develop in the adhesive that seals the duodenoscope's distal cap
onto the scope. Contaminated tissue and fluids could leak into the
duodenoscope through these openings.
pentaxmedical.com