China NMPA Product Recall - Electronic bronchoscope

Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its electronic bronchoscope (Registration Certificate No. 20183062416) on June 6, 2019. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, stemmed from reports of a significant malfunction. The primary issue involved the disposable suction button (MAJ-209) breaking and becoming stuck on the endoscope during use. This critical failure directly impacts the device's suction capacity, leading to a reduced field of vision for medical professionals and the potential for surgical procedures to be interrupted. A Class II recall indicates that the product's use may cause temporary or medically reversible adverse health consequences, or that the likelihood of serious adverse health consequences is remote. The required action by Olympus Trading (Shanghai) Co., Ltd. is to retrieve the affected electronic bronchoscopes from the market to mitigate potential risks to patient safety and ensure the integrity of medical interventions. Further details on specific product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form."