Post-market safety signals of energy-based surgical devices: a cross-specialty disproportionality analysis of the FDA MAUDE database with robotic-platform validation and regulatory triangulation, 2015-2025.
PMID: 42860471 ·
R, u, i, f, e, n, g, , S, h, i
JournalJournal of robotic surgery
Year
PMID42860471
Abstract
Post-market safety evidence for energy-based surgical devices is fragmented. We characterized adverse-event signals in the FDA MAUDE database, validated them on a third (robotic) platform, and triangulated across regulatory and international sources. Medical Device Reports (2015-2025) under electrosurgical and ultrasonic product codes were analyzed with reporting odds ratios (RORs), stratified by specialty and procedure, with robustness checks. All reports under the robotic-system code were retr
Official Source
View on PubMed →Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.