Scholarlink

<p>To summarize medical device reports (MDRs) between 2012 and 2022 relating to staplers within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). The MAUDE database was analysed for all MDRs relating to each FDA-approved stapler for the last ten years. Event descriptions were reviewed and characterized into specific event types for all the different manufacturers. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Pooled Relative risk was used to compare data. Overall, 712 reports were retrieved in 10 years. In all, 413/712 (58%) were reported as malfunction of the device while 292/712 (41%) as injury. The most frequently reported adverse events (AEs) were Misfire (111/712: 15.6%), Failure to form staple (92/712: 12.9%), Mechanical jam (76/712: 10.7%) and Failure to fire (72/712: 10.1%). In terms of manufacturer: 401/712 (56%) were Covidien, 172/712 (24%) were Teleflex Medical and 139/712 (19.5%) were Ethicon Instruments. When comparing on disproportional analysis the different manufacturers, Teleflex medical’s staplers were safer in terms of failure to fire and failure to form staple and Covidien showed the safest profile for misfire and along with Ethicon for mechanical jam. According to MAUDE database the most frequent complications related to staplers are misfire, failure to form staple, mechanical jam and failure to fire and the reported adverse events vary among the different manufacturers.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Trends and incidence of reported events associated with staplers: an analysis of the food and drug administration’s manufacturer and user facility device experience database

  • 期刊论文

  • 发表日期：

    2026年1月19日

查看全文
  • Jordi Stira,
  • Riccardo Lombardo,
  • Carmen Gravina,
  • Antonio Cicione,
  • Giorgia Tema,
  • Antonio Nacchia,
  • Andrea Tubaro,
  • Cosimo De Nunzio

摘要

To summarize medical device reports (MDRs) between 2012 and 2022 relating to staplers within the Manufacturer and User Facility Device Experience (MAUDE) database maintained by The Food and Drug Administration (FDA). The MAUDE database was analysed for all MDRs relating to each FDA-approved stapler for the last ten years. Event descriptions were reviewed and characterized into specific event types for all the different manufacturers. All data is de-identified and in compliance with the Health Insurance Portability and Accountability Act (HIPAA). No further data was available in the database. Pooled Relative risk was used to compare data. Overall, 712 reports were retrieved in 10 years. In all, 413/712 (58%) were reported as malfunction of the device while 292/712 (41%) as injury. The most frequently reported adverse events (AEs) were Misfire (111/712: 15.6%), Failure to form staple (92/712: 12.9%), Mechanical jam (76/712: 10.7%) and Failure to fire (72/712: 10.1%). In terms of manufacturer: 401/712 (56%) were Covidien, 172/712 (24%) were Teleflex Medical and 139/712 (19.5%) were Ethicon Instruments. When comparing on disproportional analysis the different manufacturers, Teleflex medical’s staplers were safer in terms of failure to fire and failure to form staple and Covidien showed the safest profile for misfire and along with Ethicon for mechanical jam. According to MAUDE database the most frequent complications related to staplers are misfire, failure to form staple, mechanical jam and failure to fire and the reported adverse events vary among the different manufacturers.