# China NMPA Product Recall - Endoscopic surgical control system and accessories da Vinci Xi Surgical System

Source: https://www.globalkeysolutions.net/records/china_product_recall/intuitive-surgical-inc/0b0ea450-5580-4342-99e0-b6d0f8bcf150/
Source feed: China

> China NMPA product recall for Endoscopic surgical control system and accessories da Vinci Xi Surgical System by Intuitive Surgical, Inc. published April 12, 2022. Recall level: Level 2 Recall. Intuitive Surgical, Inc. initiated a voluntary Class II recall for specific models and batches of it

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Intuitive Surgical, Inc. is voluntarily recalling its endoscopic surgical control system and accessory, the da Vinci Xi Surgical System.
- Company Name: Intuitive Surgical, Inc.
- Publication Date: 2022-04-12
- Product Name: Endoscopic surgical control system and accessories da Vinci Xi Surgical System
- Recall Level: Level 2 Recall
- Recall Reason: Because this involves specific models and batches of products, there is an issue with the predicted values in the risk management document for injury events caused by incomplete closure of disposable vascular cutting and closure instruments leading to bleeding.
- Discovering Company: Intuitive Fosun Medical Devices Technology (Shanghai) Co., Ltd.
- Manufacturing Company: Intuitive Surgical, Inc.
- Summary: Intuitive Surgical, Inc. initiated a voluntary Class II recall for specific models and batches of its endoscopic surgical control system and accessory da Vinci Xi Surgical System. Announced by the National Medical Products Administration (NMPA) on April 12, 2022, this action addresses a significant safety concern. The main issue identified is the potential for bleeding injury to patients, attributed to the inadequate closure performance of disposable vascular cutting and closure instruments utilized with the system. Although the document does not specify inspection dates, it details the manufacturer's proactive measure to mitigate patient risk. The recall pertains to products under Registration Certificate No.: 国械注进2018. Intuitive Surgical, Inc. is responsible for executing this recall, with comprehensive details regarding affected products available in an attached "Medical Device Recall Event Report Form." This recall underscores the company's dedication to patient safety and compliance with NMPA regulatory standards, ensuring the removal of potentially faulty devices from circulation to prevent adverse patient outcomes. The Class II classification indicates that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote.

Company: https://www.globalkeysolutions.net/companies/intuitive-surgical-inc/02e7ab6e-a4d4-46fc-9c87-8b4d958db04d/