Special Alerts

The United States Food and Drug Administration (FDA) has posted a medical device safety alert concerning Olympus Medical Systems Corporation High Flow Insufflation Unit [Model number: UHI-4]

According to the FDA, the manufacturer is recalling its Olympus High Flow Insufflation Unit because the unit may over-insufflate (inflate) air into the body with no warning or alarm.

The use of the affected unit may cause serious adverse health consequences, including air embolism, and arrythmias including bradycardia, asystole, or cardiac arrest. Other risks include collapsed lung, kidney or urinary problems, oxygen cut off to organs, and air trapped under the skin. Other necessary or complex medical procedures may be delayed because of over-insufflation, and death may occur.

The manufacturer sent an Urgent Medical Device Corrective Action Letter to all affected customers and requested customers to:

• Inspect inventory and identify any UHI-4 High flow insufflation Unit(s).
• Discontinue use of all units until the investigation into the cause of the problem is completed and additional instructions are provided by Olympus. Quarantine and mark units appropriately by the user’s site to prevent usage.
• If a facility does not have alternatives or is unable to obtain alternatives, it may use the UHI-4 with extreme caution per the considerations outlined in the Letter.
• Ensure all personnel are completely knowledgeable and thoroughly trained on the contents of the Letter.

For further information, please visit https://www.fda.gov/medical-devices/medical-device-recalls/olympus-recalls-olympus-high-flow-insufflation-unit-due-over-inflation

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 1 Nov 2023