Updated Status of Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication

As noted in the FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes. In February 2016, Pentax issued updated, validated manual reprocessing instructions for the ED-3490TK Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and continues to recommend that facilities using Pentax ED-3490TK duodenoscopes train staff on the updated instructions and implement them, if they have not already done so. In January 2017, Pentax informed customers about a potential issue associated with the distal cap of the ED-3490TK and began a program to inspect all customers' ED-3490TK duodenoscopes. On February 7, 2018, 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. 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 FDA cleared theupdated design and labeling for the ED-3490TK on February 7, 2018.  The reprocessing instructions for the recently cleared ED-3490TK have not changed since the February 2016 update. For more information, please see the Updated Status of Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication.