Surgical Energy-Based Device Injuries and Fatalities Reported to the Food and Drug Administration - 19/06/15

Doi : 10.1016/j.jamcollsurg.2015.03.031

Douglas M. Overbey, MD ^a, Nicole T. Townsend, MD ^a, Brandon C. Chapman, MD ^a, Daine T. Bennett, MD ^a, Lisa S. Foley, MD ^a, Aline S. Rau, MD ^a, Jeniann A. Yi, MD ^a, Edward L. Jones, MD ^b, Greg V. Stiegmann, MD, FACS ^a, Thomas N. Robinson, MD, MS, FACS ^a,^⁎
^a Department of Surgery, University of Colorado School of Medicine, Aurora, CO
^b Department of Surgery, Ohio State University, Columbus, OH

^∗Correspondence address: Thomas N Robinson, MD, MS, FACS, 12631 East 17th Ave, MS C313, Aurora, CO 80045.

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.

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.

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Plan

Interobserver reliability

Statistical analysis

Results

Report demographics

Combined injury and death report summary

Patterns of injury by device

	Disclosure Information: Nothing to disclose.
	Disclosures outside the scope of this work: Dr Robinson's institution received grant money from Medtronic and Covidien. Dr Robinson is the principal investigator on research grants from Medtronic and Covidien.