Abstract：
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.
journal_name
J Am Coll Surgjournal_title
Journal of the American College of Surgeonsauthors
Bhoyrul S,Vierra MA,Nezhat CR,Krummel TM,Way LWdoi
10.1016/s1072-7515(01)00913-9keywords:
subject
Has Abstractpub_date
2001-06-01 00:00:00pages
677-83issue
6eissn
1072-7515issn
1879-1190pii
S1072-7515(01)00913-9journal_volume
192pub_type
杂志文章abstract：BACKGROUND:An initiative was established to improve value-based care for pancreatic surgery in a large nonprofit health system. Cost data were presented bimonthly to a hepatobiliary clinical performance group via videoconference. STUDY DESIGN:The direct costs were calculated for all patients undergoing distal pancreat...
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journal_title：Journal of the American College of Surgeons
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journal_title：Journal of the American College of Surgeons
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journal_title：Journal of the American College of Surgeons
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