# China NMPA Product Recall - Electronic thoracoscopic and laparoscopic

Source: https://www.globalkeysolutions.net/records/china_product_recall/olympus-winter-the-gmbh/487e5ecc-2a41-4779-ad6b-b87f9be409b4/
Source feed: China

> China NMPA product recall for Electronic thoracoscopic and laparoscopic by Olympus Winter & The GmbH published December 15, 2015. Recall level: Level 2 Recall. Olympus Trading (Shanghai) Co., Ltd., acting for manufacturer Olympus Winter & The GmbH, initiated a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Olympus Trading (Shanghai) Co., Ltd. voluntarily recalls electronic thoracoscopes and laparoscopes.
- Company Name: Olympus Winter & The GmbH
- Publication Date: 2015-12-15
- Product Name: Electronic thoracoscopic and laparoscopic
- Recall Level: Level 2 Recall
- Recall Reason: Overseas manufacturers have received complaints from overseas markets regarding occasional instances of excessively high tip temperatures on electronic thoracoscopes and laparoscopes. An investigation revealed that in a very small number of batches of WA50040A and WA50042A laparoscopes manufactured after February 2015, the temperature sensors may have been damaged. Under certain circumstances, unintended control of the heating element could lead to excessively high endoscope temperatures, posing a potential risk. This could result in injury if the endoscope accidentally comes into contact with tissues or organs during surgery. No related complaints or adverse event reports have been received in China.
- Discovering Company: Olympus Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Olympus Winter & The GmbH
- Summary: Olympus Trading (Shanghai) Co., Ltd., acting for manufacturer Olympus Winter & The GmbH, initiated a voluntary Class II recall of its Electronic Thoracolaparoscopic Endoscopes, specifically models WA50040A and WA50042A. This action, reported to the National Medical Products Administration (NMPA) on November 16, 2015, and publicly announced on December 15, 2015, was prompted by complaints from overseas markets. These complaints detailed instances where the endoscope's tip experienced excessive temperatures during use. A subsequent investigation confirmed that a small number of temperature sensors in specific product batches manufactured after February 2015 might be faulty. This flaw could lead to unintended control of the heating element, causing the endoscope's tip to overheat. Such overheating presents a potential risk of thermal injury to tissues or organs if the device accidentally contacts them during surgical procedures. While no related adverse events were reported within China, the company undertook this global recall. In accordance with NMPA's recall management framework, affected medical institutions are mandated to immediately discontinue using the identified 184 units distributed in China and facilitate their return.

Company: https://www.globalkeysolutions.net/companies/olympus-winter-the-gmbh/4a33f862-d052-4d17-b4e3-9f508a70153e/