# China NMPA Product Recall - Cannula/Cannula System

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-winter-ibe-gmbh-germany/508d0aa1-9b5f-4733-bd34-d65e8eb0f8c3/
Source feed: China

> China NMPA product recall for Cannula/Cannula System by Olympus Winter & Ibe GmbH (Germany) published May 19, 2010. Recall level: Level 2 Recall. This document outlines a Level II medical device recall issued by Olympus Winter & Ibe (GMBH) German

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Cannula and Casing System Recall Event Report Form
- Company Name: Olympus Winter & Ibe GmbH (Germany)
- Publication Date: 2010-05-19
- Product Name: Cannula/Cannula System
- Recall Level: Level 2 Recall
- Recall Reason: Product A5948 experienced spontaneous detachment of its distal end, which was subsequently surgically removed. Third-party laboratory analysis revealed that the fracture of the distal end of the cannula needle core was caused by a crack at the laser weld joint, indicating that the material of the distal end component may not have been suitable for welding. The investigation found that between April 2007 and April 2008, the supplier of the distal end component supplied parts with materials that did not meet specifications, potentially causing a decrease in the weld strength between the distal end and the needle core body in some batches of products, which could, in severe cases, lead to the distal end of the needle core detaching.
- Discovering Company: Olympus Winter & Ibe GmbH (Germany)
- Manufacturing Company: Olympus Winter & Ibe GmbH (Germany)
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/olympus-winter-ibe-gmbh-germany/5946a5b2-d31a-4407-8b5b-35849172b70f/