Olympus High-Flow Insufflation Unit

2023: Product recall after patient's death

On October 18, 2023, the U.S. Food and Drug Administration (FDA) announced the recall of defective Olympus injectors. The use of these devices can harm the health of patients and even provoke a fatal outcome.

We are talking about the Olympus High-Flow Insufflation Unit - UHI-4. Insufflation involves blowing something (for example, gas, powder or steam) into the body cavity during medical procedures. This method, in particular, is used to increase the working space during laparoscopic operations by pumping carbon dioxide. The UHI-4 insuffler has a high maximum flow rate (up to 45 liters per minute) and advanced functionality, including automatic smoke removal. The device can be used to insufflate cavities of various sizes. The manufacturer's website states that the device "works with high efficiency and reliability in accordance with the strict requirements of surgical laparoscopy."

Olympus UHI-4

The FDA notice notes that as of October 2023, there are one death and several cases of harm to the health of patients that may be associated with the use of defective UHI-4 devices. The problem is that excessive abdominal insufflation occurs during laparoscopic procedures. This can trigger cardiac arrest in certain patients, such as those with arrhythmias.

The recall program affects 3136 Olympus UHI-4 injectors. Initially, they were distributed in the United States, but could get to other regions. As of October 2023, there is no exact data on the number of patients affected by the use of defective devices.^[1]

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