Pentax Medical issued an urgent medical device correction and removal notification to its customers, informing them of a required replacement to the forceps elevator and the O-ring seal and distal end cap of its ED-3490TK duodenoscopes. The company also has to update the product’s operation manual to recommend annual maintenance. FDA cleared Pentax Medical’s updated design and labeling for the recalled duodenoscope on February 7.
“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.” – FDA
The agency recommends that healthcare facilities acknowledge Pentax Medical’s correction and removal notification, and identify all affect products in their facility. More information is available in an updated safety communication on FDA’s website.