China NMPA Product Recall - Electronic duodenoscope; electronic duodenoscope; fiberoptic duodenoscope

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electronic and fiberoptic duodenoscopes, as announced by the National Medical Products Administration (NMPA) in early January 2020. The decision to recall these medical devices stems from a critical safety concern: the forceps wire within the endoscopes may experience breakage or wear. This degradation can lead to the wire bending and protruding from the tip of the endoscope during use. Such a protrusion presents a serious risk of injury to both patients undergoing diagnostic or therapeutic procedures and the healthcare professionals operating the instruments. This voluntary action, publicized through the Shanghai Municipal Drug Administration, underscores Olympus's commitment to patient safety and adherence to regulatory standards overseen by the NMPA. The recall specifically targets models registered under CFDA Import/Export Nos. 20113221997, 20063222000, and 2007222030. Although the document does not specify particular inspection dates, the recall's timing indicates a responsive measure to identified product deficiencies. Olympus Trading (Shanghai) Co., Ltd. is taking the necessary steps to address these potential hazards, with comprehensive details regarding affected product models, specifications, and batches provided in an associated 'Medical Device Recall Event Report Form,' ensuring full transparency in managing this quality issue.