Trocar injuries in laparoscopic surgery.
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.


METHODS
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.
Bhoyrul
S
S
Department of Surgery, Stanford University School of Medicine, Palo Alto, CA, USA.
Vierra
M A
MA
Nezhat
C R
CR
Krummel
T M
TM
Way
L W
LW
D000009:Abdominal Muscles / Q000293:injuries*; D001808:Blood Vessels / Q000293:injuries*; D002423:Cause of Death; D004209:Disposable Equipment / Q000706:statistics & numerical data; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D006406:Hematoma / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control; D006801:Humans; D015994:Incidence; D007431:Intraoperative Complications / Q000453:epidemiology* / Q000209:etiology* / Q000517:prevention & control; D020706:Laparoscopes / Q000009:adverse effects* / Q000706:statistics & numerical data; D010535:Laparoscopy / Q000009:adverse effects* / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D017751:Safety Management; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D014781:Viscera / Q000293:injuries*