China NMPA Product Recall - Electronic duodenoscope (trade name: EVIS LUCERA), electronic duodenal endoscope

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its Electronic Duodenoscope, marketed under the trade name EVIS LUCERA, as announced by the National Medical Products Administration (NMPA) on April 12, 2019. This action was prompted by a decision from the Shanghai Food and Drug Administration (Medical Device Decision No. 2019-088) to address significant product safety concerns. The main issue identified was wear of the lifting forceps wire within the duodenoscope, which resulted in adverse health impacts, including injuries to both patients during procedures and hospital cleaning staff. The affected products, registered under certificate numbers 20143225876, 20183062531, and 20113222826, are subject to this recall. Under the NMPA's regulatory framework, Olympus Trading (Shanghai) Co., Ltd. is required to manage the retrieval of these medical devices from the market to ensure patient safety and compliance with medical device regulations. The Class II recall designation indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.