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Robotic stapler use: Is it safe?-FDA database analysis across multiple surgical specialties
Zane Giffen1, Austin Ezzone1, Obi Ekwenna1
1Department of Urology and Renal Transplantation, University of Toledo, Toledo, OH, United States of America.
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.
Insights
Robotic stapler use in surgery has potential complications like malfunction and misfire. Further research is needed to understand the full rate of these adverse events.
Area of Science:
- Surgical Technology
- Medical Device Safety
Background:
- Robotic-assisted surgery is widely adopted across surgical specialties.
- Robotic staplers offer enhanced surgeon control but have limited documented complication data.
Purpose of the Study:
- To investigate and report adverse events associated with robotic stapler use.
- To identify common complications linked to robotic stapler devices.
Main Methods:
- A review of the U.S. Food and Drug Administration's (FDA) MAUDE database was conducted.
- Adverse events specifically related to robotic stapler devices were extracted and analyzed.
Main Results:
- Frequently reported complications included device malfunction, failure to form a staple line, fragmentation, and misfire.
- Since 2014, 31 Clavien-Dindo grade II or higher complications were linked to robotic stapler use.
Conclusions:
- Adverse events such as malfunction and misfire are reported with robotic staplers.
- More research is required to determine the prevalence of robotic stapler use and its associated complication rates.
