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

PLoS One. 2021 Jun 24;16(6):e0253548. doi: 10.1371/journal.pone.0253548. eCollection 2021.


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.

MeSH terms

  • Databases, Factual*
  • Equipment Failure*
  • Humans
  • Robotic Surgical Procedures* / adverse effects
  • Robotic Surgical Procedures* / instrumentation
  • Surgical Staplers / adverse effects*
  • Surgical Stapling / adverse effects
  • Surgical Stapling / instrumentation
  • United States
  • United States Food and Drug Administration

Grant support

The authors received no specific funding for this work.