Injuries Associated with Peritoneal Entry Device in Laparoscopic Surgery: An Analysis of Reports to the FDA

Although laparoscopy provides numerous benefits over open surgery, the initial entry into the peritoneal cavity carries the risk of potentially life-threatening visceral injury. We sought to characterize the burden of entry injuries associated with a Veress needle vs a direct trocar or other entry method for patients undergoing abdominal surgery.

Cross-sectional study of patient events reported to the US Food and Drug Administration Manufacturer and User Facility Device Experience (FDA MAUDE) with a post-market surveillance database.

All healthcare providers reporting to the FDA MAUDE database.

All patients with laparoscopic entry injuries reported to the FDA MAUDE database over all available years (January 1988 to December 2024).

Laparoscopic and robotic surgeries.

After screening 4875 reports, 109 patients suffering entry injury with Veress and 158 patients suffering entry injury with direct trocar or other methods were identified for inclusion in the final analysis. A total of 449 reports were excluded for an unknown method of entry. Patient outcomes, mechanism and location of injury, surgeon specialty, and planned procedure were compared between the two groups, with death as the primary outcome. There were 16 deaths in the Veress group and 36 in the direct trocar or other group. Patients in the direct trocar or other group were somewhat more likely to experience bowel injury, whereas patients in the Veress group were somewhat more likely to experience vascular injury. Overall, there was no association between entry method and the odds of death vs other injury (odds ratio 0.72; 95% confidence interval, 0.30-1.71).

In events reported to the FDA MAUDE database, there was no significant association between entry method and the odds of death vs other injury. This finding must be interpreted in the context of missing information and unmeasured potential confounders. Higher quality post-market device surveillance is needed.