Olympus initiated a recall of its UHI-4 abdominal insufflation devices after reviewing reports of patient injuries and one death.
There were reports of “patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used,” according to an Oct. 18 entry in the Food and Drug Administration’s medical device recall database. The UHI-4 unit is used for insufflation of the abdominal cavity for diagnostic and operational laparoscopy. Insufflation is the act of blowing a substance like gas into a body cavity.
The entry stated that the injuries may be due to over insufflation of the abdominal cavity from the use of the device. The FDA labeled the recall as a Class I event, the severest classification.
An Olympus spokesperson said in an emailed statement that the “corrective action, and notification to the FDA, was taken following a thorough assessment of adverse event complaints involving serious patient injury and one death,” adding that all affected parties will be “updated as necessary.”
In a separate email, a spokesperson said the company cannot comment on the total number of injury reports or when the company first knew of the safety issue.
Olympus initiated the recall on Sept. 22, affecting 3,136 units, according to the FDA’s database.