# China NMPA Product Recall - Electronic thoracoscopic and laparoscopic

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-vieinte-and-yibei-company/b5c61256-c8ea-4caa-9db9-ebaf2540e6b3/
Source feed: China

> China NMPA product recall for Electronic thoracoscopic and laparoscopic by Olympus Vieinte and Yibei Company published June 19, 2017. Recall level: Level 2 Recall. Olympus Viente and Yibei Company, in collaboration with Olympus Trading (Shanghai) Co., Ltd., initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Viein and E-Tech voluntarily recall electronic thoracoscopes and laparoscopes.
- Company Name: Olympus Vieinte and Yibei Company
- Publication Date: 2017-06-19
- Product Name: Electronic thoracoscopic and laparoscopic
- Recall Level: Level 2 Recall
- Recall Reason: A malfunctioning temperature sensor in the product could cause excessively high temperatures, potentially leading to injury to medical staff or patients.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Vieinte and Yibei Company
- Summary: Olympus Viente and Yibei Company, in collaboration with Olympus Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of their electronic thoracolaparoscopic endoscopes. This action, published by the National Medical Products Administration (NMPA) on June 19, 2017, addresses a critical product defect. The main issue identified is a damaged temperature sensor within the affected devices, leading to the potential for excessively high tip temperatures. This malfunction poses a significant risk of thermal injury to both medical staff and patients during use. The recall applies to electronic thoracic and laparoscopes registered under No. (Imported) 20133222427. While specific inspection dates are not detailed in this recall notice, the company's voluntary action demonstrates its response to the identified safety concern under NMPA's regulatory framework. The required action involves the recall of these devices to mitigate potential harm. Further specifics regarding affected models, specifications, and batch numbers are contained within the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/olympus-vieinte-and-yibei-company/614a3096-52f4-4eaa-9d5d-41ef0a7e55f7/