Department of Surgery, Texas Tech HSC Paul Foster School of Medicine, El Paso, TX, USA.
Universidad Autonoma Guadalajara, Guadalajara, Mexico.
JSLS. 2022 Jan-Mar;26(1). doi: 10.4293/JSLS.2021.00074.
Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported to the Food and Drug Administration which maintains the Manufacturer and User Facility Device Experience (MAUDE) database. We examined adverse stapler events reported to the MAUDE database, specifically with regards to bariatric surgery.
The MAUDE database was queried for adverse events caused by staplers between January 1, 2018 - December 31, 2020; events reported by Intuitive, Ethicon, and Medtronic/Covidien; and limited our search to "gastric bypass", "sleeve gastrectomy", "stapler malfunction" combined with each company.
There were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive. Approximately 3.5 million staple reloads sold in the study period. The reported misfire rate for Medtronic was 0.04% and for Ethicon was 0.02%. Data for Intuitive was unavailable. The most common reported event for Medtronic was failure to fire (n = 349), followed by misfire (n = 186). For Ethicon, the most common event was failure to fire (n = 146), followed by mechanical problems (n = 27). The most common event with the Intuitive stapler was leak (n = 10) and bleeding from staple line (n = 8).
Stapler malfunction is a very rare event in metabolic and bariatric surgery. All of the major stapler producers have transitioned to powered staplers with excellent safety profiles. Open and honest reporting about stapler malfunction is essential to determine the true safety of these ubiquitous devices.
在减重手术中，吻合口渗漏是一个严重的问题，也是导致严重发病率和死亡率的主要原因。医疗器械不良事件会向美国食品和药物管理局报告，该机构维护制造商和用户设施设备体验（MAUDE）数据库。我们检查了向 MAUDE 数据库报告的与吻合器相关的不良事件，特别是与减重手术相关的事件。
从 2018 年 1 月 1 日至 2020 年 12 月 31 日，我们在 MAUDE 数据库中查询了因吻合器引起的不良事件；查询了 Intuitive、Ethicon 和 Medtronic/Covidien 报告的事件；并将我们的搜索范围限制在“胃旁路术”、“袖状胃切除术”、“吻合器故障”与每家公司的组合。
报告了 883 例 Medtronic 不良事件、353 例 Ethicon 不良事件和 35 例 Intuitive 不良事件。在研究期间，售出了约 350 万次吻合器重新加载。报告的 Medtronic 未击发率为 0.04%，Ethicon 为 0.02%。Intuitive 的数据不可用。Medtronic 最常见的报告事件是未击发（n = 349），其次是误击发（n = 186）。对于 Ethicon，最常见的事件是未击发（n = 146），其次是机械问题（n = 27）。Intuitive 吻合器最常见的事件是渗漏（n = 10）和吻合线出血（n = 8）。
吻合器故障在代谢和减重手术中是一种非常罕见的事件。所有主要的吻合器生产商都已过渡到具有出色安全性能的电动吻合器。公开、诚实地报告吻合器故障对于确定这些无处不在的设备的真正安全性至关重要。
