China NMPA Product Recall - Endoscopic stapler and disposable stapler

Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for its endoscopic cutting staplers and associated disposable attachment cartridges. This significant action, publicly reported on August 24, 2020, by the Shanghai Municipal Drug Administration under the National Medical Products Administration (NMPA), was prompted by a critical complaint originating from Japan. The complaint detailed an incident where a stapler malfunctioned during use, failing to form properly and leading to patient blood loss. Further internal investigation by Covidien revealed a potential assembly error during the manufacturing process as the underlying cause. This defect resulted in poor staple formation and other operational problems with the devices. The recall, categorized as Class II, indicates that the product defect could cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The affected products fall under Registration Certificate No.: 20153020083. As part of the regulatory framework, the company is required to identify and remove all affected models, specifications, and batches from the market, with detailed information available in the "Medical Device Recall Event Report Form." This demonstrates Covidien's commitment to addressing manufacturing quality issues and safeguarding patient safety.