Adverse events and device malfunctions in da Vinci robotic surgery: an analysis of MAUDE data from the recent decade.
Journal
Journal of robotic surgery
Journal Volume
20
Journal Issue
1
ISSN
1863-2491
Date Issued
2025-12-10
Author(s)
Abstract
The role of robotic surgery has expanded rapidly over the past decade. Although clinical outcomes of the widely adopted da Vinci surgical systems are well reported, large-scale evaluations of adverse events and device safety remain limited. The United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database provides a useful resource for characterizing malfunctions and safety outcomes across platforms. MAUDE reports involving da Vinci surgical systems from January 2015 to June 2025 were reviewed. Events were classified as malfunctions, injuries, or deaths, with malfunctions further characterized by type. Conversions and procedure abortions were identified and analyzed. The rates of adverse events were calculated and compared between robotic platforms. Among an estimated 15.9 million da Vinci robotic surgeries performed during the study period, 66,651 MAUDE reports were identified. There were 420.1 MAUDE reports, including 55.2 injuries, 3.1 deaths, 21.8 conversions, and 2.1 procedure abortion events, per 100,000 procedures. Compared with the da Vinci X/Xi, the da Vinci SP showed significantly higher risks of reported injury (RR 29.9, P < 0.001), death (RR 6.2, P < 0.001), conversion (RR 9.4, P < 0.001), and procedure abortion (RR 16.1, P < 0.001). Although adverse events and malfunctions associated with da Vinci robotic surgeries are relatively uncommon, the widespread use of these systems results in a substantial number of events. These findings highlight the need for prospective registry-based surveillance to validate platform-specific safety profiles as robotic surgery becomes increasingly integrated into clinical practice.
Subjects
Adverse events
Da vinci
Malfunction
Robotic surgery
Type
journal article