Electrosurgical and Electrocautery Device Failures and Best Reporting Practices. Issue 1 (January 2019)

• Record Type: Journal Article
• Authors: Block, Frank E.; Waheed, Saphia; Lee, Ting-Hsuan Joyce
• Is Part Of: Journal of clinical engineering. Volume 44:Issue 1(2019)
• Publication Date: 2019-01
• Subjects: Biomedical engineering -- Periodicals; 610.28
• DOI: 10.1097/JCE.0000000000000311
• Languages: English
• ISSNs: 0363-8855

Abstract

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.