Olympus Corporation of the Americas: Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.

Hazard

There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.

Details from the source

Reason for recall: There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures. Distribution: US Nationwide distribution. Quantity: 3136 units Lot/code info: UDI-DI: 04953170324147; All Serial Numbers

UPC codes

04953170324147

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.