INTUITIVE SURGICAL, INC
Manufacturer adverse-event records for INTUITIVE SURGICAL, INC come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2004–2026 · heavy-book · typical Death-code · balanced
Volume signature
INTUITIVE SURGICAL, INC sits in the heavy MAUDE book
INTUITIVE SURGICAL, INC accounts for 120,857 FDA MAUDE reports (#29 of 434, heavy-book tercile). Death-coded event_type share is 0.53% (typical); Injury share 10.0% (balanced).
What the volume reading shows for INTUITIVE SURGICAL, INC
The standout signal for INTUITIVE SURGICAL, INC is filing volume: 120,857 adverse-event reports in FDA MAUDE (#29 of 434, heavy-book). Death-coded event_type share sits at 0.53% (typical).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair INTUITIVE SURGICAL, INC with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.
Reports span 13 device types, led in this extract by Malfunction at 108,074 (89.4% of event_type total). Peak single-year volume reaches 50,012 reports across 21 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (13)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.