Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study.
Adverse event reporting in head and neck transoral robotic surgery: a MAUDE database study.
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DOI：
10.1007/s11701-020-01185-1
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发表时间：
2021-12
影响因子：
2.3
通讯作者：
Spanos WC
中科院分区：
文献类型：
--
作者：
Assam JH;DeHaan MC;Bakken S;Spanos WC
使用达芬奇手术系统的经口机器人手术（TORS）于2009年获得美国食品和药物管理局的批准。目前，大多数可获得的关于tor程序的安全信息描述了在大批量学术中心的临床试验或系列中发生的不良事件。本研究的目的是通过查询FDA数据库，对报道的头颈部手术中与达芬奇器械相关的不良事件进行分类。在MAUDE数据库中搜索2009年1月至2020年5月期间生成的TORS安全事故报告，使用关键词“da Vinci”和“Intuitive Surgical”。总共产生了3312份医疗器械记录。在这36例头颈部不良事件中，报告是由作者通过人工筛选数据确定的。总体而言，死亡是报告的最常见不良事件，占所有报告事件的44%。最常见的死亡原因是围手术期出血，而不是手术引起的器械故障或结构损伤。这被发现与其他发表的经口消融手术的结果相似。这项研究表明，与达芬奇系统的tor相关的少量报告不良事件似乎反映了使用其他方法进行经口手术的相同程序的预期。
Transoral robotic surgery (TORS) using the da Vinci Surgical system was approved by the US Food and Drug Administration in 2009. Currently, most available safety information on TORS procedures describes adverse events occurring in the context of clinical trials or series at high-volume academic centers. The goal of this study was to catalog reported adverse events associated with the da Vinci device in head and neck procedures by querying an FDA database. A search was performed on the MAUDE database inspecting for TORS safety incident reports generated from January 2009 through May 2020 using key words “da Vinci” and “Intuitive Surgical”. A total of 3312 medical device records were produced. Of these 36 head and neck adverse events, reports were identified through manual screening of the data by the authors. Death was found to be the most common adverse event reported overall, manifesting in 44% of all reported incidents. The most frequent source of mortality was found to be hemorrhaging in the perioperative period rather than incidents of device malfunction or structural damage from surgery. This was found to be similar to the results of other published series for transoral ablative surgery. This study suggests that the small number of reported adverse events related to TORS with the da Vinci system seems to mirror what would be expected from the same procedures using other methods for transoral surgery.
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影响因子：
7.8
作者：
Pollei, Taylor R.;Hinni, Michael L.;Walter, Logan C.
通讯作者：
Walter, Logan C.
影响因子：
2.6
作者：
de Almeida, John R.;Byrd, James K.;Genden, Eric M.
通讯作者：
Genden, Eric M.
影响因子：
1.7
作者：
Crawford, Julia A.;Bahgat, Ahmed Yassin;Magnuson, J. Scott
通讯作者：
Magnuson, J. Scott
影响因子：
3.4
作者：
Vergez, Sebastien;Lallemant, Benjamin;Mallet, Yann
通讯作者：
Mallet, Yann
DOI：
10.1002/hed.24259
发表时间：
2016-03-01
影响因子：
2.9
作者：
Loerincz, Balazs B.;Moeckelmann, Nikolaus;Knecht, Rainald
通讯作者：
Knecht, Rainald