China NMPA Product Recall - Electronic thoracic and laparoscopic endoscopy

On November 6, 2020, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electronic thoracic and laparoscopic endoscopes (Registration Certificate No.: 20173221340). This action was taken due to a critical safety concern: extremely accidental damage to the tip temperature sensor. This damage can compromise the temperature control mechanism for the anti-fogging function, potentially causing the endoscope tip to reach excessively high temperatures. The primary risk associated with this malfunction is patient injury, as an overheated tip could cause harm if it contacts tissues or organs during surgery. This recall was reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, highlighting the company's proactive response to a significant medical device safety issue. As a required action, Olympus Trading (Shanghai) Co., Ltd. is systematically recalling all affected electronic thoracic and laparoscopic endoscopes. Detailed information regarding specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form" referenced in the regulatory announcement.