Products: Endoluminal, Surgical robot. Risk band: High
RobotRisk index 74.4/100 (severity- and time-weighted incidents) · ranked 1 of 25 among Medical robotics companies with incidents (173 tracked).
Analyst brief
Intuitive Surgical's index of 74.4 ranks 1 of 25 companies in Medical robotics with incident history. The record includes three recall entries (two Class II, one Class I), three malfunction entries, and repeated MAUDE database analyses, with the March 2026 Class I recall of SureForm stapler reloads following a patient death carrying the highest severity score of 5 in the set. Two independent long-horizon MAUDE analyses, one from 2013 covering 2000-2013 and one described as covering 2015-2025, both document a continuing adverse-event rate across roughly a decade each, indicating a sustained pattern rather than isolated incidents. The record combines regulatory recall actions with device-malfunction litigation and recurring statistical surveillance findings, reflecting both a documented long-term adverse-event baseline and periodic acute recall events layered on top of it.
Risk index
74.4/100RobotRisk index
22.1/100Median index across the 25 Medical robotics companies with incident history (173 tracked, 148 with none)
1 of 25Rank in Medical robotics (of 25 with incident history)