Complications associated with optical-access laparoscopic trocars

OBJECTIVE: To investigate the number and type of serious complications associated with optical-access trocars reported by sources other than the medical literature. METHODS: Optical-access trocars, first introduced in 1994, were designed to decrease the risk of injury to intra-abdominal structures by allowing the surgeon to visualize abdominal wall layers during placement. To date, very few complications with their use have been reported in the medical literature. MEDLINE, the Food and Drug Administration's Medical Device Reporting, and the Manufacturer and User Facility Device Experience databases were searched for reports of complications occurring during the use of optical-access trocars for laparoscopic access. RESULTS: Only two serious complications resulting from the use of optical-access trocars (vena cava injuries) have been reported in the medical literature. However, 79 serious complications using these techniques have been cited in the Medical Device Reporting and Manufacturer and User Facility Device Experience databases since 1994. These include 37 major vascular injuries involving aorta, vena cava, or iliac vessels, 18 bowel perforations, 20 cases of significant bleeding from other sites, three liver lacerations, and one stomach perforation. Four of these complications resulted in patient deaths. CONCLUSION: Optical-access trocars may be associated with significant injuries despite having the ability to visualize tissue layers during insertion. (C) 2002 by the American College of Obstetricians and Gynecologists.