Electrosurgical and Electrocautery Device Failures and Best Reporting Practices

Abstract

Electrosurgical units play a vital role in operating rooms today. Their failures have the potential to harm both patients and surgeons. In this article, US Food and Drug Administration (FDA) postmarket safety reports involving electrosurgical units were examined to determine the most common failure categories of these devices. Based on this analysis, mechanical failure was the most prevalent failure experienced, primarily through part detachment, failing to articulate or movement/motion issues, or improper or poor cutting. When these issues are properly reported to FDA, FDA can work with manufacturers to improve these devices and ensure that these devices remain safe and effective.

Best practices for reporting electrosurgical unit malfunctions

“…Device-related information to convey includes the device age; how many times it had been used previously; if it is single use; if there were any sounds, smells, error messages, arcing, or other signs related to the malfunction; and the location and sequence of events. 2 The proper reporting of ESU malfunctions and any associated adverse events alerts manufacturers to these problems and allows them to take action to address them; methods may include adapting the device design, manufacturing process, or labeling; performing training; or issuing a recall. The FDA also can assist manufacturers in their improvement efforts.…”

“…1 In this update, new guidance was added regarding reporting electrosurgical unit (ESU) malfunctions and ESU-related patient injuries (e.g., bleeding, tissue tears, burns) or deaths to the U.S. Food and Drug Administration (FDA), the device manufacturer, and other regulatory bodies as needed. 1,2 Reporting is an essential step in increasing awareness of these adverse and sentinel events and helping manufacturers improve devices to prevent their recurrence. 2 As outlined in a 2019 study, almost half of the 620 ESU malfunction reports to the FDA Medical Product Safety Network in a two-year period describe a mechanical failure, the most common of which involved the tip or other part of the handpiece detaching from the device.…”

“…1,2 Reporting is an essential step in increasing awareness of these adverse and sentinel events and helping manufacturers improve devices to prevent their recurrence. 2 As outlined in a 2019 study, almost half of the 620 ESU malfunction reports to the FDA Medical Product Safety Network in a two-year period describe a mechanical failure, the most common of which involved the tip or other part of the handpiece detaching from the device. Commonly reported electrical malfunctions included improper device activation (e.g., activation failure, intermittent activation) and ESU cable damage (e.g., cable insulation and connector failure).…”

“…The most reported use-related issue was using too much force, resulting in bending or breaking of the device. 2…”

“…This month’s Guideline First Look article highlights the updated AORN “Guideline for electrosurgical safety.” 1 In this update, new guidance was added regarding reporting electrosurgical unit (ESU) malfunctions and ESU‐related patient injuries (e.g., bleeding, tissue tears, burns) or deaths to the U.S. Food and Drug Administration (FDA), the device manufacturer, and other regulatory bodies as needed 1,2 . Reporting is an essential step in increasing awareness of these adverse and sentinel events and helping manufacturers improve devices to prevent their recurrence 2 …”