Surgical Energy-Based Device Injuries and Fatalities Reported to the Food and Drug Administration.

Background: Energy-based devices are used in virtually every operation. Our purposes were to describe causes of energy-based device complications leading to injury or death, and to determine if common mechanisms leading to injury or death can be identified.

Study Design: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was searched for surgical energy-based device injuries and deaths reported over 20 years (January 1994 to December 2013). Device-related complications were recorded and analyzed.

Results: We analyzed 178 deaths and 3,553 injuries. Common patterns of complications were: thermal burns, 63% (n = 2,353); hemorrhage, 17% (n = 642); mechanical failure of device, 12% (n = 442); and fire, 8% (n = 294). Events were identified intraoperatively in 82% (3,056), inpatient postoperatively in 9% (n = 351), and after discharge in 9% (n = 324). Of the deaths, 12% (n = 22) occurred after discharge home. Common mechanisms for thermal burn injuries were: direct application, 30% (n = 694); dispersive electrode burn, 29% (n = 657); and insulation failure, 14% (n = 324). Thermal injury was the most common reason for death (39%, n = 70). The mechanism for these thermal injuries was most frequently direct application (84%, n = 59, p < 0.001 vs all other mechanisms). Fires were most common with monopolar "Bovie" instruments (88%, n = 258, p < 0.001 vs all other devices) when they were used in head and neck operations (66%, n = 193, p < 0.001 vs all other locations).

Conclusions: Complications due to energy-based devices occur from 4 main causes: thermal burn, hemorrhage, mechanical failure, and fire. Thermal direct application injuries are the most common reason for both injury and death.