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

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.

Automated summary

Introduction Robotic-assisted techniques are common in many surgical subspecialties. However, there is limited information on surgical complications related to robotic stapler use. After reviewing the FDA database, it was found that the most frequently reported robotic stapler complications include malfunction, failure to form staple line, device fragmentation, and misfire. Since 2014, there have been 31 Clavien-Dindo grade II or higher complications attributed to stapler use. Further research is needed to quantify the associated complication rate of robotic stapler use.