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Electrosurgical and Electrocautery Device Failures and Best Reporting Practices

Block, Frank E. III, PhD, PE; Waheed, Saphia, MS; Lee, Ting-Hsuan Joyce, MHS

doi: 10.1097/JCE.0000000000000311
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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.

Corresponding author: Frank E. Block III, PhD, PE, is a biomedical engineer in the Office of Surveillance and Biometrics at the US Food and Drug Administration and an Adjoint Assistant Professor of Biomedical Engineering at Vanderbilt University. He can be reached at 10903 New Hampshire Ave, Silver Spring, MD 20993 or frank.block@fda.hhs.gov.

Saphia Waheed, MS, is a biomedical engineer in the Office of Surveillance and Biometrics at the US Food and Drug Administration, Silver Spring, MD.

Ting-Hsuan Joyce Lee, MHS, is an ORISE fellow in the Office of Surveillance and Biometrics at the US Food and Drug Administration, Silver Spring, MD.

The authors declare no conflicts of interest.

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