Health Devices. 1994 Jun;23(6):257-9.
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.
医疗保健器械风险管理协会（ECRI）最近调查了一起事件，一名患者在腹腔镜胆囊切除术期间因腹腔内压力过高导致气体栓塞并发症死亡。在该事件中，使用了一台Birtcher Medical Systems 6400氩气刀在肝脏床面上进行止血。在应用氩气增强凝血（AEC）后不久，患者的腹腔内压力升高超过了气腹机的报警极限，触发了声音警报。当注意到警报时，气腹机上显示的腹腔内压力为33毫米汞柱。与此同时，患者开始出现与气体栓塞相符的症状；后来尸检证实了栓塞。自我们最初的调查以来，我们还了解到另外两起在腹腔镜手术中使用AEC系统时发生的事件（美国食品药品监督管理局1993年[医疗器械报告文件编号67284]；马斯特拉杰洛普洛斯等人1992年[使用Beamer One氩气罐——见下文]），导致气体栓塞和机械性肺损伤。
ECRI认为，在腹腔镜手术中使用AEC会使患者因腹腔内压力过高以及氩气取代二氧化碳而面临气体栓塞的重大风险。因此，仅当没有同等或更优的凝血方式可用，且已充分评估相关患者的风险和益处时，才应在腹腔镜手术中使用AEC。如果临床医生决定使用AEC，他们在手术过程中必须格外谨慎。
