China NMPA Product Recall - Electronic duodenoscope (trade name: EVIS EXERA Ⅱ)

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electronic duodenoscopy endoscope, trade name EVIS EXERA Ⅱ (Model TJF-Q180V), on October 18, 2021. This action stemmed from internal investigation results, rather than external inspection dates. The primary issue identified was that if reprocessing procedures proved ineffective, or if liquid intrusion occurred, the continued use of the TJF-Q180V device could lead to deteriorated adhesives or other structural damage. This degradation compromises the endoscope's integrity, potentially resulting in contamination and posing a significant infection risk to patients. The recall is managed under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The required action is the voluntary removal of these specific products from circulation to mitigate potential patient safety concerns. Detailed information regarding affected models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form."