February 7, 2018
FDA clears updated design, labeling for Pentax duodenoscope
Editor's Note
The Food and Drug Administration (FDA) on February 7 announced that it had cleared the updated design and labeling for Pentax Medical's duodenoscope Model ED-3490TK.
Pentax replaced the forceps elevator mechanism, O-ring seal, and distal end cap, and updated the Operation Manual to recommend annual maintenance.
The design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The reprocessing instructions have not changed.
Posted 02/07/2018] AUDIENCE: Gastroenterology, Nursing, Risk Manager ISSUE: Pentax issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance.
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