# China NMPA Product Recall - Electronic nasopharyngeal endoscope; electronic nasopharyngeal endoscope; video endotracheal intubation endoscope; fiber optic bronchoscope; ultrasonic fiber optic electronic bronchoscope; OES fiber optic bronchoscope; OES bronchial fiber optic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchoscope (trade name: EVIS EXERA II); electronic bronchoscope; electronic bronchial endoscope; EVIS electronic bronchoscope; ultrasonic fiber optic electronic bronchoscope; ultrasonic fiber optic bronchoscope; electronic bronchoscope; bronchoscope (trade name: EVIS LUCERA); EVIS bronchial electronic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchial endoscope; fiber optic bronchoscope

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/effa9736-2e01-44c5-9955-911615e591fd
Source feed: China

> China NMPA product recall for Electronic nasopharyngeal endoscope; electronic nasopharyngeal endoscope; video endotracheal intubation endoscope; fiber optic bronchoscope; ultrasonic fiber optic electronic bronchoscope; OES fiber optic bronchoscope; OES bronchial fiber optic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchoscope (trade name: EVIS EXERA II); electronic bronchoscope; electronic bronchial endoscope; EVIS electronic bronchoscope; ultrasonic fiber optic electronic bronchoscope; ultrasonic fiber optic bronchoscope; electronic bronchoscope; bronchoscope (trade name: EVIS LUCERA); EVIS bronchial electronic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchial endoscope; fiber optic bronchoscope by Olympus Trading (Shanghai) Co., Ltd. published August 06, 2019. Recall level: Level 2 Recall. Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of various electronic end

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. specializes in electronic nasopharyngeal endoscopes; electronic nasopharyngeal endoscopes; video endotracheal intubation endoscopes; fiber optic bronchoscopes; ultrasonic fiber optic electronic bronchoscopes; OES fiber optic bronchoscopes; OES fiber optic bronchoscopes for bronchial use; electronic bronchoscopes (trade name: EVIS LUCERA); electronic bronchoscopes (trade name: EVIS EXERA Ⅱ); electronic bronchoscopes; electronic bronchial endoscopes; EVIS electronic bronchoscopes; ultrasonic fiber optic electronic bronchoscopes; ultrasonic fiber optic bronchoscopes; electronic bronchoscopes; bronchoscopes (trade name: EVIS LUCERA); EVIS electronic bronchial endoscopes; electronic bronchial endoscopes (trade name: EVIS). LUCERA (electronic bronchoscope; fiber optic bronchoscope) voluntary recall
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-08-06
- Product Name: Electronic nasopharyngeal endoscope; electronic nasopharyngeal endoscope; video endotracheal intubation endoscope; fiber optic bronchoscope; ultrasonic fiber optic electronic bronchoscope; OES fiber optic bronchoscope; OES bronchial fiber optic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchoscope (trade name: EVIS EXERA II); electronic bronchoscope; electronic bronchial endoscope; EVIS electronic bronchoscope; ultrasonic fiber optic electronic bronchoscope; ultrasonic fiber optic bronchoscope; electronic bronchoscope; bronchoscope (trade name: EVIS LUCERA); EVIS bronchial electronic endoscope; electronic bronchoscope (trade name: EVIS LUCERA); electronic bronchial endoscope; fiber optic bronchoscope
- Recall Level: Level 2 Recall
- Recall Reason: If non-Olympus accessories are used with the products in question, excessive external force will be applied to the bronchoscope forceps tubing, which may cause the biopsy port to loosen. It is currently impossible to determine whether the loosening of the forceps tubing has caused infection or death.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of various electronic endoscope products, including electronic nasopharyngeal endoscopes, video tracheal intubation endoscopes, fiberoptic bronchoscopes, and ultrasonic fiberoptic electronic bronchoscopes. This recall, published on August 6, 2019, addresses a significant safety concern. The core issue arises when non-Olympus accessories are used with the affected devices, leading to excessive external force being applied to the bronchoscope forceps tubing. This can cause the biopsy port to loosen. While it has not been determined if this issue has resulted in patient infection or death, the company is taking proactive steps to mitigate potential risks to patient safety. The recall operates under China's medical device regulatory framework, with affected products holding registration certificates from authorities such as the Shanghai Food and Drug Administration and the National Medical Products Administration (NMPA). As a required action, Olympus Trading (Shanghai) Co., Ltd. is recalling all specified models, specifications, and batches of the affected endoscopes. Detailed information regarding the specific products involved can be found in the 

Company: https://www.globalkeysolutions.net/companies/olympus-trading-shanghai-co-ltd/510963e8-8b01-4884-b017-bc21b376ca33