China NMPA Product Recall - Electronic thoracoscopic and laparoscopic

On May 8, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Olympus Trading (Shanghai) Co., Ltd. concerning its Electronic Thoracolaparoscopic Endoscopes. The recall was prompted by the discovery of a critical issue: in rare cases, the endoscopes' tip temperature conductor can fail, leading to a malfunction in the rapid anti-fogging function's temperature control. This defect allows the device tip to reach excessive temperatures, presenting a risk of injury to tissues and organs if it comes into contact with a patient. As a required action under the NMPA's oversight, Olympus Trading (Shanghai) Co., Ltd. decided to recall all affected products to safeguard patient welfare. While specific inspection dates are not applicable to this recall notice, the company's proactive measure highlights compliance with medical device regulatory responsibilities. Detailed information on the models, specifications, and batches of the recalled endoscopes is available in the "Medical Device Recall Event Report Form." The regulatory framework for this action is the general oversight of medical device safety by the NMPA.