Adverse events and device malfunctions in robotic thyroidectomy: a decade-long analysis of the MAUDE database

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Robotic thyroidectomy (RT) has gained increasing patient interest and clinical adoption in recent years. However, device-related adverse events and malfunctions remain poorly characterized. A review of the Manufacturer and User Facility Device Experience (MAUDE) database was conducted using the keyword "robotic thyroidectomy" between January 2016 and December 2025. Eligible reports were manually reviewed and classified by malfunctioning domain, intraoperative management, clinical consequence, procedural outcome, post-event manufacturer evaluation, and reporting timeliness. Thirty-two reports were included, and all events occurred intraoperatively. Adjunct energy device accounted for the majority of reports (68.8%), followed by robotic system (25.0%) and access/interface component (6.3%). The most frequently described event pattern was fragment/breakage. Device/component exchange (56.3%) and fragment retrieval/removal (46.9%) were common management measures. Despite these events, 25 procedures (78.1%) were completed robotically as planned, three (9.4%) were completed under downgraded robotic conditions and only one (3.1%) required open conversion. No severe patient injury was noted. In terms of reporting timeliness, the United States Food and Drug Administration (FDA) received 13 reports (40.6%) over 30 days after the event occurred. Meanwhile, four of the 31 evaluable reports (12.9%) exceeded the manufacturer-to-FDA reporting window of 30 days. Although RT-related MAUDE reports were limited and most events appeared manageable, the associated surgical burden may include workflow disruption, repeated troubleshooting, device exchange, and downgraded robotic continuation. These findings highlight the need for RT-specific risk awareness, balanced patient counseling, operative preparedness, structured troubleshooting pathways and timely, standardized post-market surveillance.

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