Fatal gas embolism caused by overpressurization during laparoscopic use of argon enhanced coagulation

ECRI recently investigated an incident in which a patient died from complications of a gas embolism caused by intra-abdominal overpressurization during a laparoscopic cholecystectomy. A Birtcher Medical Systems 6400 argon beam coagulator was used to coagulate bleeding on the liver bed during the incident. Shortly after application of argon enhanced coagulation (AEC), the patient's intra-abdominal pressure increased above the insufflator's alarm limit, activating an audible alarm. When the alarm was noticed, the intra-abdominal pressure displayed on the insufflator was 33 mm Hg. Concurrently, the patient began experiencing difficulties consistent with gas embolism; the embolism was later confirmed by autopsy. Since our initial investigation, we have also become aware of two other incidents during laparoscopic use of an AEC system (FDA 1993 [MDR File No. 67284]; Mastragelopulos et al. 1992 [using a Beamer One Argon Gas Cart--see below]) that resulted in gas embolism and mechanical lung damage.

ECRI believes that the use of AEC during laparoscopic procedures presents patients with a significant risk of gas embolism from abdominal overpressurization and displacement of CO2 by argon gas. Therefore, AEC should be used only during laparoscopic procedures when no equal or superior modality of coagulation is available and when the associated patient risks and benefits have been fully examined. If clinicians decide to use AEC, they must exercise extreme caution during the procedure.