China NMPA Product Recall - pneumoperitoneum machine

Carl Storz Endoscopy (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its insufflator (Registration Certificate No.: 20142065825) on March 13, 2020. This action, overseen by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, addresses a critical product defect. The primary issue involves the CO2 low-pressure tubing plug, where a component's inner diameter deviates from specified design requirements. This manufacturing flaw creates a risk of misconnection: if the CO2 plug is accidentally connected to an O2 interface, despite being correctly marked for CO2 use only, it could wedge into place and allow unintended airflow. Such a scenario, particularly if high-frequency surgical instruments are in use while a patient is inhaling O2, poses a significant safety hazard, potentially causing reversible or irreversible patient harm. In response, Carl Storz Endoscopy (Shanghai) Co., Ltd. is recalling all affected insufflators. The company has provided a "Medical Device Recall Event Report Form" for detailed information on specific models, specifications, and batches subject to this recall, ensuring compliance with NMPA's medical device regulatory framework. This proactive measure aims to mitigate potential patient risks associated with the defective component.