Abstracts Only

2000 Digestive Disease Week

# 2283 Trocar Injuries in Laparoscopic Surgery.
Sunil Bhoyrul, Mark A. Vierra, Camran Nezhat, Thomas Krummel, Lawrence W. Way, San Francisco, CA, Stanford, CA

Disposable trocars with safety shileds are used for laparoscopic access. Although the safety shield was designed to minimize the visceral injury, the risk of this complication is not eliminated. In this study, we analyzed trocar injuries reported to the food and drug admininstration (FDA) to identify the risk factors associated with these injuries. Manufacturers are required to report medical device related incidents to the FDA, whose records through 1996 are available on the internet. We analyzed all such reports and identified 629 trocar injuries from 1993-1996. The information was entered into a database with fields for the type of trocar, nature of injury, kind of laparoscopic procedure, and explanatory comments from the surgeon and manufacturer. There were 3 major types of injury: 408 vascular injuries (VI), 182 other visceral injuires, mainly bowel injuries (BI), and 30 abdominal wall hematomas. Of the 32 deaths, 26 (81%) resulted from VI, and the remainder (19%)from BI. 87% of the deaths from VI 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 implicated in the fatal vascular injuries. 93% of the non fatal VIs involved disposable trocars with saftey shields, and 7% involved direct view trocars. There was an assocoated BI in 10% of the VIs. 12 VIs (3%) occured when the trocar was inserted in the absence of a pneumoperitoneum. In 41 cases (10%), the surgeon thought that the device had malfunctioned, but in only 2 instances (1%), was the malfunction subsequently confirmed upon inspection of the device. 91% of BI involved trocars with saftey shields, and 7% involved direct view trocars. The diagnosis of an enterotomy was delayed in 10% of cases, and the mortality in this group was 21%. The likelihood of injury was not related to any procedure or any manufacturer. This data suggests that safety shields and direct view trocars cannot prevent serious injuires. Vascular injuries are more likely to be fatal if they involve the aorta or inferior vena cava. Bowel injuires often go unrecognized, in which case they are highly lethal. Device malfunction is rarely the cause of a serious injury.

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