title: Surgical Energy-Based Device Injuries and Fatalities Reported to the Food and Drug Administration.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Douglas M
authors.initials: DM
authors.lastname: Overbey
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Nicole T
authors.initials: NT
authors.lastname: Townsend
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Brandon C
authors.initials: BC
authors.lastname: Chapman
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Daine T
authors.initials: DT
authors.lastname: Bennett
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Lisa S
authors.initials: LS
authors.lastname: Foley
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Aline S
authors.initials: AS
authors.lastname: Rau
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Jeniann A
authors.initials: JA
authors.lastname: Yi
authors.affiliation: Department of Surgery, Ohio State University, Columbus, OH.
authors.forename: Edward L
authors.initials: EL
authors.lastname: Jones
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Greg V
authors.initials: GV
authors.lastname: Stiegmann
authors.affiliation: Department of Surgery, University of Colorado School of Medicine, Aurora, CO. Electronic address: thomas.robinson@ucdenver.edu.
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Robinson
mesh_terms: D002056:Burns / Q000209:etiology* / Q000401:mortality; D016208:Databases, Factual; D055615:Electrical Equipment and Supplies / Q000009:adverse effects*; D004868:Equipment Failure; D005390:Fires / Q000706:statistics & numerical data; D006801:Humans; D007431:Intraoperative Complications / Q000209:etiology* / Q000401:mortality; D019106:Postoperative Hemorrhage / Q000209:etiology* / Q000401:mortality; D014481:United States; D014486:United States Food and Drug Administration