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. Published by Elsevier Inc.
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. Published by Elsevier Inc.
Authors: Jason M Samuels; Heather Carmichael; Krzysztof J Wikiel; Thomas N Robinson; Carlton C Barnett; Teresa S Jones; Edward L Jones Journal: Surg Endosc Date: 2019-06-20 Impact factor: 4.584
Authors: Krzysztof J Wikiel; Douglas M Overbey; Heather Carmichael; Brandon C Chapman; John T Moore; Carlton C Barnett; Teresa S Jones; Thomas N Robinson; Edward L Jones Journal: Surg Endosc Date: 2020-06-26 Impact factor: 4.584
Authors: Nicole T Townsend; Edward L Jones; Doug Overbey; Bruce Dunne; Jennifer McHenry; Thomas N Robinson Journal: Surg Endosc Date: 2016-11-18 Impact factor: 4.584
Authors: Douglas M Overbey; Heather Carmichael; Krzysztof J Wikiel; Douglas A Hirth; Brandon C Chapman; John T Moore; Carlton C Barnett; Teresa S Jones; Thomas N Robinson; Edward L Jones Journal: Surg Endosc Date: 2020-05-08 Impact factor: 4.584