Olympus, a medical supply company based in Pennsylvania, warned customers that its High Flow Insufflation Unit may suddenly over-inflate air into a patient's body without a warning. One death and 10 serious injuries have been reported to the FDA.
The device inflates the abdomen or colon with carbon dioxide gas, and it is used during laparoscopic and endoscopic surgeries, the FDA said Oct. 30. The product also provides automatic suction and smoke evacuation.
The FDA labeled the issue as a Class I recall, the most serious type, for about 3,000 devices. The products are not being pulled from the market, but Olympus is recommending users stop using it "except when an alternative is not available or cannot be obtained," according to an Oct. 27 news release.
Clinicians using the High Flow Insufflation Unit UHI-4 should use "extreme caution," the company said.
Olympus has received adverse event reports of gas embolism and over insufflation, including arrhythmias reported as "short cardiac arrests," happening during surgical procedures.