China NMPA Product Recall - Electronic thoracoscopic and laparoscopic

Olympus Viente and Yibei Company, in collaboration with Olympus Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of their electronic thoracolaparoscopic endoscopes. This action, published by the National Medical Products Administration (NMPA) on June 19, 2017, addresses a critical product defect. The main issue identified is a damaged temperature sensor within the affected devices, leading to the potential for excessively high tip temperatures. This malfunction poses a significant risk of thermal injury to both medical staff and patients during use. The recall applies to electronic thoracic and laparoscopes registered under No. (Imported) 20133222427. While specific inspection dates are not detailed in this recall notice, the company's voluntary action demonstrates its response to the identified safety concern under NMPA's regulatory framework. The required action involves the recall of these devices to mitigate potential harm. Further specifics regarding affected models, specifications, and batch numbers are contained within the accompanying Medical Device Recall Event Report Form.