# China NMPA Product Recall - Electronic duodenoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-medical-corporation/a9a2ad8f-b9e2-46c5-913a-a70676977e6b/
Source feed: China

> China NMPA product recall for Electronic duodenoscope by Olympus Medical Corporation published December 07, 2016. Recall level: Level 1 Recall. On December 7, 2016, the National Medical Products Administration (NMPA) announced a Class I volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. voluntarily recalls electronic duodenoscopes
- Company Name: Olympus Medical Corporation
- Publication Date: 2016-12-07
- Product Name: Electronic duodenoscope
- Recall Level: Level 1 Recall
- Recall Reason: Overseas manufacturers have received complaints from the US market regarding patients infected with carbapenem-resistant Enterobacteriaceae (CRE) via electronic duodenoscopes. An investigation revealed that the tip of the electronic duodenoscope contains a forceps; if cleaning and disinfection are not thorough, there is a potential risk of infection.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Medical Corporation
- Summary: On December 7, 2016, the National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Olympus Trading (Shanghai) Co., Ltd. for its Electronic Duodenoscopy Endoscope (Model TJF-Q180V). This action followed complaints from the U.S. market detailing patients contracting carbapenem-resistant Enterobacteriaceae (CRE) infections, which were linked to the use of these devices. Investigations determined that inadequate cleaning and disinfection, particularly of the intricate lifting forceps at the duodenoscope's tip, posed a potential infection risk. While China had not received related adverse event reports, Olympus proactively implemented the recall under NMPA's regulatory framework. The recall affected 12 units sold in China. Required actions included tracing the final destination of all affected products and instructing sales units, distributors, and medical institutions to immediately cease their use. Additionally, after-sales service units were tasked with distributing updated, comprehensive cleaning, disinfection, and sterilization guidelines, including instructions for disposable pipeline cleaning. Olympus also committed to providing on-site guidance for proper cleaning procedures and conducting on-site repairs for the affected duodenoscopes to enhance patient safety.

Company: https://www.globalkeysolutions.net/companies/olympus-medical-corporation/527e2e59-6901-42c2-a360-40be55f6edb8/