China NMPA Product Recall - Electronic duodenoscope

On December 7, 2016, the National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Olympus Trading (Shanghai) Co., Ltd. for its Electronic Duodenoscopy Endoscope (Model TJF-Q180V). This action followed complaints from the U.S. market detailing patients contracting carbapenem-resistant Enterobacteriaceae (CRE) infections, which were linked to the use of these devices. Investigations determined that inadequate cleaning and disinfection, particularly of the intricate lifting forceps at the duodenoscope's tip, posed a potential infection risk. While China had not received related adverse event reports, Olympus proactively implemented the recall under NMPA's regulatory framework. The recall affected 12 units sold in China. Required actions included tracing the final destination of all affected products and instructing sales units, distributors, and medical institutions to immediately cease their use. Additionally, after-sales service units were tasked with distributing updated, comprehensive cleaning, disinfection, and sterilization guidelines, including instructions for disposable pipeline cleaning. Olympus also committed to providing on-site guidance for proper cleaning procedures and conducting on-site repairs for the affected duodenoscopes to enhance patient safety.