Reported device problems and patient outcomes in da Vinci robotic robotic gastric and upper-gastrointestinal procedures: an FDA MAUDE database analysis.

Robotic gastric and upper-gastrointestinal procedures include bariatric/metabolic operations, conventional/oncologic gastrectomy, and other procedures. Postmarket surveillance of reported device problems in this heterogeneous setting remains limited. To describe reported device problems and patient outcomes in robotic gastric and upper-gastrointestinal procedures using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. We conducted a retrospective analysis of MAUDE reports from 2009 to 2025. Procedures were categorized as bariatric/metabolic, conventional/oncologic gastrectomy, or other/unspecified gastric or upper-gastrointestinal procedures. Device-problem descriptors, report characteristics, and report-level outcome associations were analyzed. Among 1,073 analyzed reports, device-problem descriptor profiles varied across reported platform categories. The da Vinci Xi category frequently included software or display descriptors, whereas the da Vinci Standard / Unspecified category frequently included stapling-related descriptors. In a procedure-adjusted multivariable model, Firing Problem (OR 9.53, 95% Wald CI 4.36-20.82), Misfire (OR 17.91, 95% Wald CI 7.10-45.21), and Failure to Form Staple (OR 17.59, 95% Wald CI 8.72-35.48) were associated with the selected severe-outcome indicator. Documentation/reporting factors were analyzed separately and were not interpreted as confirmed device malfunctions. This report-level analysis describes patterns of submitted device-problem descriptors and selected patient-outcome flags in robotic gastric and upper-gastrointestinal procedures. These associations are hypothesis-generating and do not establish device root cause, malfunction incidence, comparative safety, clinical effectiveness, or causal risk. Prospective, procedure-specific surveillance with standardized outcome adjudication and procedure-volume denominators is needed to evaluate device performance and clinical outcomes.