Updated design, labeling cleared for duodenoscope

The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap.


On Feb. 7, the FDA cleared the updated design and labeling for the Pentax Medical Duodenoscope Model ED-3490TK. The changes aim to reduce the potential for patient fluids to leak into the closed elevator channel and underneath the distal cap. The manufacturer had previously recalled all ED-3490TK duodenoscopes to replace certain device parts and update the operation manual to recommend annual maintenance. The FDA continues to monitor the association between reprocessed endoscopes and transmission of infectious agents.