UPDATE: Oct. 30, 2023: Olympus Corporation’s recall of abdominal insufflation devices has been associated with reports of 21 malfunctions, 10 serious injuries and one death, according to a notice posted Monday by the Food and Drug Administration.
The agency said devices have been recalled because of the risk of malfunctioning, where units may over-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,” the FDA’s notice stated. “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.”
Olympus asked customers in an Oct. 25 letter to quarantine affected devices and only use machines when there is no alternative or an alternative machine cannot be obtained, according to a Friday press release.
An Olympus spokesperson said in an emailed statement that the company has not “confirmed the adverse events are related to a safety issue specific to the device. The investigation in connection with the reports was initiated in June 2023 and is ongoing.”
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.