China NMPA Product Recall - Disposable bipolar high-frequency surgical instruments

Gyrus ACMI, Inc. has announced a voluntary Class II recall of its disposable bipolar high-frequency surgical instruments, as publicly reported by the National Medical Products Administration (NMPA) on January 23, 2024. This action stems from an escalation in complaints documented by Olympus Trading (Shanghai) Co., Ltd., concerning critical performance issues with the devices. Specifically, the recall addresses instances of intraoperative jaw breakage observed in cutting forceps, particularly for products identified under batch number PK-CF0533. This malfunction presents a significant safety risk during surgical procedures, potentially compromising patient outcomes and operational efficacy. The affected instruments are registered under the National Medical Device Registration Certificate No. 20203010481, indicating their prior approval for use within the regulatory framework overseen by the NMPA. A Class II recall designation signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Gyrus ACMI, Inc.'s decision to initiate a voluntary recall underscores its commitment to product safety and regulatory compliance. All relevant stakeholders are directed to refer to the "Medical Device Recall Event Report Form" for comprehensive details regarding the specific models, specifications, and batch numbers implicated in this corrective action, ensuring proper identification and management of the recalled devices.