Olympus issues Class I recall for endoscopy devices following patient death

Olympus Corporation has issued a Class I recall for its high-flow insufflation unit UHI-4 used to facilitate laparoscopic and endoscopic observation, diagnosis and treatment. 

Olympus has requested patients discontinue use of the device until further notice except when an alternative is not available or cannot be obtained, according to an Oct. 27 release. 

Olympus is assessing the issue after receiving reports of patients suffering complications from over insufflation — including arrhythmias reported as "short cardiac arrests," gas embolism, and one death — during surgical procedures where UHI-4s were used. 

Olympus is requesting the devices be quarantined to prevent use, providing users with detailed information about risks and recommending extreme caution if alternative devices are not available and they must use the device.

Class I recalls are the most serious type of recall issued by the FDA.

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