Intuitive Surgical

Analyst brief

Intuitive Surgical's record, the largest reviewed here, contains seven entries spanning 2013 through 2026, producing the maximum index value of 100 and the 100th percentile within medical-robotics, a critical band. 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.

Comparisons over time

Incident log (7 unique incidents)

Alternatives in medical robotics