• Janie Fuller, Binita S Ashar, and Julia Carey-Corrado.
• Office of Surveillance and Biometrics, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Rockville, Maryland, USA. jyf@cdrh.fda.gov
• J Minim Invasive Gynecol. 2005 Jul 1;12(4):302-7.

AbstractLaparoscopic trocars, medical devices used to gain access into the abdominal cavity, are the most common device named in malpractice injury claims associated with laparoscopic procedures. As part of its ongoing adverse event reporting program, the U.S. Food and Drug Administration (FDA) requires manufacturers and user facilities to file a report whenever a device was or may have been a factor in a death or serious injury. The FDA collects data from these reports in its Manufacturer and User Facility Device Experience (MAUDE) database. This study presents an analysis of fatality and injury data on laparoscopic trocars found in MAUDE reports received from January 1, 1997, through June 30, 2002, including 31 fatal injury cases and 1353 reports on nonfatal injuries. Cholecystectomy was the procedure most frequently associated with both fatal and nonfatal trocar injuries. Most fatalities involved vascular injuries. All fatality reports that identified the trocar design involved either a shielded trocar (which has a retractable shield that covers the trocar blade before and after insertion to help protect abdominal and pelvic organs from inadvertent puncture) or an optical trocar (which allows laparoscopists to view the cutting tip as it penetrates the tissues). Narrative comments cited surgical technique, device problems, and patient characteristics as contributing factors. Among nonfatal injuries, a change in surgical management such as additional surgical procedure--primarily laparotomy--prolonged surgery, or aborted surgery was reported most frequently for vascular and hollow viscus injuries. Many reports did not identify the device model, surgical procedure, or event timing, limiting Food and Drug Administration (FDA) and manufacturer investigations into whether the device contributed to the event. The most common manufacturer conclusions indicated the trocar was not returned, and no conclusions could be drawn about the trocar's contribution to the event. Fatalities occur with procedures in which shielded trocars and optical trocars are used. Further study is needed to evaluate the high proportion of reports associated with laparoscopic cholecystectomy. Laparoscopists should retain for evaluation any devices implicated in patient injuries and should ensure that detailed information on adverse events is provided in adverse event reports to the FDA. The FDA's Manufacturer and User Facility Device Experience (MAUDE) database can be a valuable source for information on adverse outcomes associated with medical devices and, given an understanding of its limitation, provides researchers with a viable adjunct to published literature and litigation surveys for obtaining this information.

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