Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, U.S.A.
Department of Otolaryngology, Harvard Medical School, Boston, Massachusetts, U.S.A.
Laryngoscope. 2020 May;130(5):1138-1143. doi: 10.1002/lary.28181. Epub 2019 Jul 11.
To identify U.S. Food and Drug Administration (FDA)-reported adverse events related to electrosurgical devices during tonsillectomy and characterize the most common devices and patient/provider sequelae.
Retrospective analysis of FDA database of device-related adverse events.
Data were extracted from the OpenFDA database for all adverse events reported for electrosurgical devices used in tonsillectomies from January 2008 to December 2017. Adverse events were classified by device, event type, etiology, complication severity, and patient disposition.
Six hundred fifty-two adverse events were identified, with 195 events (30%) leading to known bodily injury to patient/provider. Device failure was the most common adverse event (202 events, 31%), followed by burns in 187 patient (98% of burns) and three provider events (2%). Burn injuries occurred most frequently with coblation devices (78 events, 42% of burns), monopolar electrocautery (48 events, 25%), and electrosurgical generators (23 events, 13%). Burn injuries most commonly occurred in the oral cavity (144 events, 76% of burn events) and were most commonly first-degree (28 events, 15%). Complications related to burns were managed conservatively for 36% of burn events (68 events), and secondary surgery was rarely required (8 events, 4%). Postoperative bleeding (173 events, 26%; 3 deaths) and intraoperative fire (73 events, 11%) were also reported. Device failures caused significant OR delay or cancellation in 17% of occurrences (35 events).
Numerous complications may occur with various devices used during tonsillectomy and can result in significant patient/provider harm and sequelae. Surgeons must understand the nature of such complications to facilitate safe perioperative care and inform preoperative patient discussions.
NA Laryngoscope, 130:1138-1143, 2020.
确定与扁桃体切除术相关的美国食品和药物管理局（FDA）报告的电外科设备不良事件，并描述最常见的设备和患者/医护人员的后遗症。
FDA 设备相关不良事件数据库的回顾性分析。
从 2008 年 1 月至 2017 年 12 月，从 OpenFDA 数据库中提取用于扁桃体切除术的电外科设备报告的所有不良事件数据。根据设备、事件类型、病因、并发症严重程度和患者处理方式对不良事件进行分类。
确定了 652 例不良事件，其中 195 例（30%）导致患者/医护人员已知身体伤害。设备故障是最常见的不良事件（202 例，31%），其次是 187 例患者（98%的烧伤）和 3 例医护人员烧伤（2%）。烧伤最常发生在等离子刀（78 例，42%的烧伤）、单极电凝（48 例，25%）和电外科发生器（23 例，13%）。烧伤最常发生在口腔（144 例，76%的烧伤事件），且多为一级烧伤（28 例，15%）。对于 36%的烧伤事件（68 例），保守治疗并发症，很少需要二次手术（8 例，4%）。还报告了术后出血（173 例，26%；3 例死亡）和术中火灾（73 例，11%）。设备故障导致 17%的情况下（35 例）手术室延迟或取消。
扁桃体切除术中使用各种设备可能会发生多种并发症，导致患者/医护人员严重伤害和后遗症。外科医生必须了解此类并发症的性质，以促进安全的围手术期护理，并告知术前患者讨论。
无。喉科学，130：1138-1143，2020 年。
