# China NMPA Product Recall - pneumoperitoneum machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/carl-stosters-endoscopes-shanghai-co-ltd/e9bc9947-bc79-459b-ab4d-02dd51dfdec4/
Source feed: China

> China NMPA product recall for pneumoperitoneum machine by Carl Stosters Endoscopes (Shanghai) Co., Ltd. published March 13, 2020. Recall level: Level 3 Recall. Carl Storz Endoscopy (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its insufflator 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Carl Storz Endoscopy (Shanghai) Co., Ltd. is voluntarily recalling its insufflator.
- Company Name: Carl Stosters Endoscopes (Shanghai) Co., Ltd.
- Publication Date: 2020-03-13
- Product Name: pneumoperitoneum machine
- Recall Level: Level 3 Recall
- Recall Reason: The CO2 low-pressure tubing plug in the affected product may contain a component with an incorrect inner diameter. The inner diameter of this component deviates from the specified dimensions. If the CO2 plug is accidentally connected to the O2 interface, airflow may occur under certain circumstances. While the CO2 plug may not completely lock into the O2 interface, it may wedge into the interface due to connection misalignment and tension on the tubing, potentially creating airflow. The potentially affected CO2 low-pressure tubing is correctly marked for CO2 and, according to the product instructions, is for CO2 use only. However, accidental use, including the use of high-frequency surgical instruments while inhaling O2, could result in reversible or irreversible harm to the patient.
- Discovering Company: Carl Stosters Endoscopes (Shanghai) Co., Ltd.
- Manufacturing Company: Carl Stosters Endoscopes (Shanghai) Co., Ltd.
- Summary: Carl Storz Endoscopy (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its insufflator (Registration Certificate No.: 20142065825) on March 13, 2020. This action, overseen by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration, addresses a critical product defect.
The primary issue involves the CO2 low-pressure tubing plug, where a component's inner diameter deviates from specified design requirements. This manufacturing flaw creates a risk of misconnection: if the CO2 plug is accidentally connected to an O2 interface, despite being correctly marked for CO2 use only, it could wedge into place and allow unintended airflow. Such a scenario, particularly if high-frequency surgical instruments are in use while a patient is inhaling O2, poses a significant safety hazard, potentially causing reversible or irreversible patient harm.
In response, Carl Storz Endoscopy (Shanghai) Co., Ltd. is recalling all affected insufflators. The company has provided a "Medical Device Recall Event Report Form" for detailed information on specific models, specifications, and batches subject to this recall, ensuring compliance with NMPA's medical device regulatory framework. This proactive measure aims to mitigate potential patient risks associated with the defective component.

Company: https://www.globalkeysolutions.net/companies/carl-stosters-endoscopes-shanghai-co-ltd/ccb32b53-9aa3-408f-aea4-76660389f9dd/