Robotic stapler use: Is it safe?–FDA database analysis across multiple surgical specialties

Author:

Giffen ZaneORCID,Ezzone AustinORCID,Ekwenna Obi

Abstract

Introduction Robotic-assisted techniques are common across many surgical subspecialties. While robotic stapling offers increased surgeon control, there is limited information on surgical complications related to robotic stapler use. Methods We reviewed the FDA’s MAUDE database for adverse events related to robotic stapler use. Results Upon review of the FDA database, the most frequently reported robotic stapler complications were malfunction, failure to form staple line, device fragmentation, and misfire. 31 Clavien-Dindo grade II or higher complications were attributed to stapler use since 2014. Conclusions Further research on prevalence of robotic stapler use is needed to quantity the associated complication rate.

Publisher

Public Library of Science (PLoS)

Subject

Multidisciplinary

Reference8 articles.

1. FDA. MAUDE—Manufacturer and User Facility Device Experience; 2020 [cited 2020 March 26]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.

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