Perioperative adverse events and device malfunctions associated with ROSA cranial stereotactic robotic surgery a...

We characterized perioperative adverse events and device malfunctions involving ROSA cranial stereotactic robotic systems in the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Reports received from 1 January 2016 through 31 July 2026 were identified using ROSA-specific brand and 510(k) searches under FDA product code HAW, with date segmentation. In the frozen dataset, deduplication yielded 1,277 unique ROSA medical device reports (MDRs); 155 were excluded and 1,122 were analysed. Two reviewers independently coded reports, followed by third senior reviewer review. Descriptive results used final consensus classifications. The ROSA cohort contained 880 (78.4%) Malfunctions, 241 (21.5%) Injuries, and 1 (0.1%) Death. Software/imaging/data (455; 40.6%) and registration/accuracy/calibration (235; 20.9%) were the leading failure domains. No reported harm was coded in 1,057 (94.2%) MDRs. Restart/reboot/power-cycle was the leading management response (392; 34.9%), and procedure delay was the leading procedural outcome (529; 47.1%). ROSA reports frequently described software, imaging, registration, and workflow disruptions. These patterns can inform equipment checks, registration verification, troubleshooting, backup pathways, and training. Report proportions do not estimate harm incidence or establish causality. The partial 2026 interval is not comparable with complete calendar years.