Olympus has told healthcare providers to stop using its insufflation hardware for laparoscopic surgery until further notice, while it examines reports of overinflation—where elevated air pressure within the abdomen has interfered with heartbeats and been linked to one patient death.
The company’s UHI-4 insufflator pumps carbon dioxide gas into the abdominal cavity, inflating it to create space for laparoscopes and minimally invasive instruments to perform diagnostic and interventional procedures. It also provides automatic suction to clear smoke and mists, and can also be used within the colon during colonoscopies. The company had once described the device's maximum CO2 flow rate of 45 liters per minute as one of the highest in the market.
Though Olympus first launched corrective actions in August, this month the FDA labeled the issue a Class I recall, the agency’s most serious rating. Spanning more than 3,100 units across the U.S., the FDA said it has received reports of 21 malfunctions, including 10 serious injuries and one death.
Olympus is not requesting that users send the UHI-4 units back to the manufacturer, but instead quarantine them and tag the hardware so they will not be used inadvertently. The company and the FDA said they can be employed if no other alternatives are available, but recommended taking extreme caution as overinflation can occur with no warning.
Olympus said it plans to issue additional instructions in the future, and that it is identifying subpopulations of patients that may be more susceptible to risks—such as children, the elderly and people with a history of cardiac arrhythmias.
The company said that some irregular heartbeats detected during surgery had been reported as “short cardiac arrests.” The FDA, meanwhile, listed complications that included air embolisms and the risk of collapsed lungs, as well as kidney or urinary issues, and ultimately the delay of medically necessary surgery for the patient’s underlying condition.
Earlier this year, Olympus received its third FDA warning letter in five months over its endoscope manufacturing, following an inspection in November 2022 of its Tokyo facilities. The agency pointed to issues with faulty end caps, as well as the company’s practices for investigating device complaints.
Editor's note: This story has been updated to clarify the flow rate of the insufflator, following an update of Olympus' marketing page November 1, after this story was published.