Bhoyrul S, Vierra M A, Nezhat C R, Krummel T M, Way L W
Department of Surgery, Stanford University School of Medicine, Palo Alto, CA, USA.
J Am Coll Surg. 2001 Jun;192(6):677-83. doi: 10.1016/s1072-7515(01)00913-9.
Disposable trocars with safety shields are widely used for laparoscopic access. The aim of this study was to analyze risk factors associated with injuries resulting from their use as reported to the Food and Drug Administration.
Manufacturers are required to report medical device-related incidents to the Food and Drug Administration. We analyzed the 629 trocar injuries reported from 1993 through 1996.
There were three types of injury: 408 injuries of major blood vessels, 182 other visceral injuries (mainly bowel injuries), and 30 abdominal wall hematomas. Of the 32 deaths, 26 (81%) resulted from vascular injuries and 6 (19%) resulted from bowel injuries. Eighty-seven percent of deaths from vascular injuries involved the use of disposable trocars with safety shields and 9% involved disposable trocars with a direct-viewing feature. The aorta (23%) and inferior vena cava (15%) were the vessels most commonly traumatized in the fatal vascular injuries. Ninety-one percent of bowel injuries involved trocars with safety shields and 7% involved direct-view trocars. The diagnosis of an enterotomy was delayed in 10% of cases, and the mortality rate in this group was 21%. In 41 cases (10%) the surgeon initially thought the trocar had malfunctioned, but in only 1 instance was malfunction subsequently found when the device was examined. The likelihood of injury was not related to any specific procedure or manufacturer.
These data show that safety shields and direct-view trocars cannot prevent serious injuries. Retroperitoneal vascular injuries should be largely avoidable by following safe techniques. Bowel injuries often went unrecognized, in which case they were highly lethal. Device malfunction was rarely a cause of trocar injuries.
带有安全防护装置的一次性套管针广泛应用于腹腔镜手术入路。本研究旨在分析向美国食品药品监督管理局报告的因使用此类套管针导致损伤的相关危险因素。
制造商被要求向美国食品药品监督管理局报告与医疗器械相关的事件。我们分析了1993年至1996年期间报告的629例套管针损伤事件。
损伤有三种类型：408例主要血管损伤、182例其他内脏损伤（主要为肠损伤）和30例腹壁血肿。在32例死亡病例中，26例（81%）死于血管损伤，6例（19%）死于肠损伤。血管损伤导致的死亡中，87%涉及使用带有安全防护装置的一次性套管针，9%涉及具有直视功能的一次性套管针。主动脉（23%）和下腔静脉（15%）是致命血管损伤中最常受创伤的血管。91%的肠损伤涉及带有安全防护装置的套管针，7%涉及直视套管针。10%的肠切开术病例诊断延迟，该组死亡率为21%。在41例（10%）病例中，外科医生最初认为套管针出现故障，但检查该器械时仅在1例中发现了故障。损伤的可能性与任何特定手术或制造商无关。
这些数据表明，安全防护装置和直视套管针不能预防严重损伤。遵循安全技术在很大程度上应可避免腹膜后血管损伤。肠损伤常未被识别，在这种情况下往往具有高度致死性。器械故障很少是套管针损伤的原因。
