# China NMPA Product Recall - Electronic thoracic and laparoscopic endoscopy

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-trading-shanghai-co-ltd/eef61231-0411-4525-9018-068abd2ec1a8/
Source feed: China

> China NMPA product recall for Electronic thoracic and laparoscopic endoscopy by Olympus Trading (Shanghai) Co., Ltd. published November 06, 2020. Recall level: Level 2 Recall. On November 6, 2020, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. is voluntarily recalling electronic thoracic and laparoscopic endoscopes.
- Company Name: Olympus Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-11-06
- Product Name: Electronic thoracic and laparoscopic endoscopy
- Recall Level: Level 2 Recall
- Recall Reason: If the tip temperature sensor of an electronic thoracic and laparoscopic endoscope malfunctions under extremely rare circumstances, it can cause the anti-fogging function to fail, resulting in excessively high tip temperature. If this occurs during surgery and comes into contact with tissues or organs, it could lead to injury or other problems.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Trading (Shanghai) Co., Ltd.
- Summary: On November 6, 2020, Olympus Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its electronic thoracic and laparoscopic endoscopes (Registration Certificate No.: 20173221340). This action was taken due to a critical safety concern: extremely accidental damage to the tip temperature sensor. This damage can compromise the temperature control mechanism for the anti-fogging function, potentially causing the endoscope tip to reach excessively high temperatures. The primary risk associated with this malfunction is patient injury, as an overheated tip could cause harm if it contacts tissues or organs during surgery. This recall was reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, highlighting the company's proactive response to a significant medical device safety issue. As a required action, Olympus Trading (Shanghai) Co., Ltd. is systematically recalling all affected electronic thoracic and laparoscopic endoscopes. Detailed information regarding specific models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form" referenced in the regulatory announcement.

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