Jacobs School Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, United States of America.
University of the Incarnate Word School of Osteopathic Medicine, San Antonio, TX, United States of America.
Am J Otolaryngol. 2024 Sep-Oct;45(5):104404. doi: 10.1016/j.amjoto.2024.104404. Epub 2024 Jul 20.
To identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy.
The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms "suction cautery," "suction electrocautery," "suction Bovie," and "suction coagulator" from January 2014 to December 2023.
165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %).
The suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.
确定在腺样体扁桃体切除术期间使用抽吸式电烙术相关的不良事件 (AE)。
使用术语“抽吸式烧灼器”、“抽吸式电烙器”、“抽吸式 Bovie”和“抽吸式凝血器”，从 2014 年 1 月至 2023 年 12 月在 FDA 制造商和用户设施设备体验 (MAUDE) 数据库中搜索。
从 MAUDE 数据库医疗设备报告 (MDR) 中收集了 165 份 AE 报告。有 36 份符合纳入标准。在 22 份报告（61.1%）中发现了患者受伤，在 14 份报告（38.9%）中发现了设备故障事件。所有患者的损伤均为热烧伤（N=22，100%）。烧伤的部位包括嘴唇（N=6，27.3%）、口腔口角（N=5，22.7%）和舌头（N=4，18.2%）。AE 的最常见原因是设备绝缘不足（N=7，19.4%）。
抽吸式电烙器装置可能会发生故障，导致患者烧伤。设备故障主要是由于设备绝缘不足、凝血问题和设备部件脱落造成的。外科医生必须意识到这些潜在的并发症，并就 AE 向家长和患者提供咨询。
