China NMPA Product Recall - Cannula/Cannula System

This document outlines a Level II medical device recall issued by Olympus Winter & Ibe (GMBH) Germany, through its domestic agent Olympus (Shanghai) Co., Ltd., for their Cannula/Cannula Needle System (models A5948 and A5949). The recall event report was published by the National Medical Products Administration (NMPA) on May 19, 2010. The core issue was the spontaneous detachment of the distal end of the cannula needle during surgical use, as reported in a market complaint. Investigations traced this malfunction to a crack at the laser weld joint, caused by an unsuitable material used for the distal end component. Further inquiry by the overseas manufacturer revealed that between April 2007 and April 2008, a supplier provided parts with incorrect materials and specifications, weakening the weld strength in specific product batches. Classified as a Level II recall under Chinese regulatory framework, indicating potential for temporary or reversible health hazards, the risk of severe injury is mitigated by the ability to detect and retrieve the detached component during surgery. Required actions included tracing all affected products, instructing all distributors and healthcare facilities to immediately cease use, implementing a product replacement program, and returning recalled units to the manufacturer for destruction. Detailed reports are mandated for any untraceable products, with the company providing regular updates and a final completion report.