# China NMPA Product Recall - Puncture device (product name: ENDOPATH XCEL)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/73e293a5-5773-4bbe-8443-1197c1a3783b/
Source feed: China

> China NMPA product recall for Puncture device (product name: ENDOPATH XCEL) by Ethicon Endo-Surgery, LLC published November 03, 2010. Recall level: . Johnson & Johnson Medical Devices Co., Ltd., on behalf of manufacturer Ethicon Endo-Surgery, LLC, in

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for Puncture Instruments
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2010-11-03
- Product Name: Puncture device (product name: ENDOPATH XCEL)
- Recall Reason: EES is recalling ENDOPATH® XCEL T™ OPTIVIEW™ due to an increase in reports of air leaks during laparoscopic surgery. Air leaks may lead to loss of pneumoperitoneum during the procedure. Loss of pneumoperitoneum may result in conversion from laparoscopic surgery to open surgery.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Johnson & Johnson Medical Devices Co., Ltd., on behalf of manufacturer Ethicon Endo-Surgery, LLC, initiated a global recall for their ENDOPATH® XCEL T™ OPTIVIEW™ Endoscopic Instruments. This recall, reported on October 21, 2010, and documented by the National Medical Products Administration (NMPA) on November 3, 2010, addresses a critical product defect. The primary issue identified was an increase in reports of air leaks during laparoscopic surgical procedures. Such leaks can result in a loss of pneumoperitoneum, potentially necessitating a conversion from minimally invasive laparoscopic surgery to a more invasive open procedure, thus impacting patient safety. The recall applies to specific models and batch numbers, with 127 affected units either manufactured or imported into China. Under the NMPA's regulatory framework, Johnson & Johnson's required corrective action involves notifying all users of the affected products about the issue and the necessary recall procedures to mitigate risks.

Company: https://www.globalkeysolutions.net/companies/ethicon-endo-surgery-llc/dfce5be3-6a9d-4239-8ba0-5d5283b81a02/