Sunday, February 9, 2025

Olympus Halts Use of Insufflator Units Over Malfunction Reports and FDA Issues Class I Recall

Similar articles

Olympus, a healthcare equipment manufacturer, has requested healthcare providers to cease using its UHI-4 insufflator unit. This unit, employed in laparoscopic surgeries, has been linked to reports of over-inflation that could potentially harm patients. The UHI-4 insufflator system operates by injecting carbon dioxide gas into the abdomen to create a space for performing minimally invasive procedures.

The U.S. Food and Drug Administration (FDA) has classified this problem as a class I recall, which is the most serious type of recall. This classification is due to the severity of 21 reported malfunction incidents, including 10 serious injuries and one fatality.

Subscribe Weekly Market Access News

* indicates required

In response to these reports, Olympus has not requested the return of the units. Rather, it has advised that the units be quarantined and distinctly marked to prevent accidental use. The company is in the process of developing additional guidelines and is identifying patient subgroups that may be at a higher risk.

This is not the first time Olympus has faced issues with its healthcare equipment. The company has received three FDA warning letters within five months concerning its endoscope manufacturing. These warnings were issued following an inspection of Olympus’s facilities in Tokyo.

The healthcare equipment industry and medical professionals are closely watching the situation. The discontinuation of the UHI-4 insufflator unit could potentially impact laparoscopic surgeries, which are widely used for a variety of medical conditions. As Olympus works to address the issue, healthcare providers are urged to follow the company’s guidance to ensure patient safety.

The potential patient harm from over-inflation underscores the need for stringent quality controls in the manufacturing of healthcare equipment. Additionally, it highlights the importance of vigilant monitoring and prompt reporting of device malfunctions to prevent further harm to patients.

Olympus’s recent challenges with the FDA and its products serve as a reminder of the critical role of regulatory bodies in maintaining patient safety in the rapidly evolving field of healthcare equipment and technology.


This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article