On February 7, 2018, the FDA cleared the updated design and labeling for the Pentax duodenoscope model ED-3490TK. The design changes were intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap. The updated design addressed the issues that lead to the recall of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal, and distal end cap. The updated Operation Manual was changed to recommend annual maintenance.
The Pentax duodenoscope model ED-3490TK is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
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.
Based on currently available information, the FDA recommends healthcare facilities make themselves aware of the manual reprocessing procedures. Healthcare facilities should continue to use these validated instructions when reprocessing Pentax ED-3490TK duodenoscope models. The validated reprocessing instructions, when followed correctly, are intended to effectively clean and high-level disinfect the Pentax ED-3490TK duodenoscope.
See the FDA Safety Alert
See the FDA Safety Communication
See the FDA’s Infections Associated with Reprocessed Duodenoscopes webpage
See also Medical Law Perspectives Report: Colonoscopy: Scoping the Risks and Liabilities