Olympus announced a field corrective action in the U.S. due to over-insufflation during use of its UHI-4 high-flow insufflation unit.
The company designed UHI-4 to facilitate laparoscopic and endoscopic observation, diagnosis and treatment. It insufflates the abdominal cavity and colon, providing automatic suction and smoke evacuation.
Olympus received complaints of patients suffering complications from over-insufflation with the device. That included arrhythmias reported as “short cardiac arrests,” and gas embolism.
The company received one report of death during a surgical procedure that used UHI-4 devices.
Olympus requested in an Oct. 25 corrective action letter that customers discontinue use of the device until further notice. Customers who don’t have an alternative available or who are unable to obtain one may use the device. Olympus said it issued this direction because it considers safety and risk mitigation as “top priorities.”
The company requests that customers quarantine and mark devices appropriately to prevent use. It plans to provide users with detailed information on potential benefits versus potential risks of over-insufflation. Olympus recommends that users exercise extreme caution if they must use the device.
According to Olympus, it intends to provide updated customer notifications. Its representatives can assist in providing a list of alternative devices.
