Trocar injuries in laparoscopic surgery

• Published in: Journal of the American College of Surgeons Vol. 192; no. 6; pp. 677 - 683
• Main Authors: Bhoyrul, Sunil, Vierra, Mark A, Nezhat, Camran R, Krummel, Thomas M, Way, Lawrence W
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.06.2001; Elsevier Science; American College of Surgeons
• Subjects: Abdomen; Abdominal Muscles - injuries; Biological and medical sciences; Blood Vessels - injuries; Cause of Death; Disposable Equipment - statistics & numerical data; Equipment Design; Equipment Failure; Equipment Safety; Hematoma - epidemiology; Hematoma - etiology; Hematoma - prevention & control; Humans; Incidence; Injuries of the abdomen. Foreign bodies of the digestive system; Intraoperative Complications - epidemiology; Intraoperative Complications - etiology; Intraoperative Complications - prevention & control; Laparoscopes - adverse effects; Laparoscopes - statistics & numerical data; Laparoscopy - adverse effects; Laparoscopy - statistics & numerical data; Medical sciences; Product Surveillance, Postmarketing; Risk Factors; Safety Management; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the digestive system; Traumas. Diseases due to physical agents; United States - epidemiology; United States Food and Drug Administration; Viscera - injuries; United States; Human; Endoscopic surgery; Iatrogenic; Laparoscopy; Epidemiology; Trauma; Abdomen; Treatment; Abdominal disease; Surgery; Risk factor; Complication; Trochar; Endoscopy
• ISSN: 1072-7515; 1879-1190
• DOI: 10.1016/S1072-7515(01)00913-9

BACKGROUND: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: 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.