FDA issues alert about PENTAX ED-3490TK duodenoscope

The U.S. Food and Drug Administration (FDA) released an important update to the February 19, 2016 safety communication to inform users about a design issue with the PENTAX ED-3490TK duodenoscope that could increase the risk of patient infection. Cracks and gaps in the adhesive that seals the device’s distal cap to its distal tip can occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and disinfect and may increase the risk of infection transmission among patients. FDA recommends that facilities and staff that use and reprocess this device implement the reprocessing procedures in accordance with the manufacturer’s reprocessing instructions issued in February 2016. Read the updated FDA safety alert.