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 · 2010–2025 · mid-book · elevated Death-code · balanced

Death-code intensity

INTUITIVE SURGICAL,INC. carries an elevated Death-code share

Death-coded event_type rows are 243 of 17,733 (1.37% · elevated tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for INTUITIVE SURGICAL,INC.

The standout signal for INTUITIVE SURGICAL,INC. is Death-code intensity: 1.37% of 17,733 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for INTUITIVE SURGICAL,INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 8 device types, led in this extract by Malfunction at 15,170 (85.5% of event_type total). Peak single-year volume reaches 6,038 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

17,733
Total Reports
243
Event-type Death
1,677
Injury Reports
8
Device Types

Event Types

Malfunction 15,170 (85.5%)
Injury 1,677 (9.5%)
Other 614 (3.5%)
Death 243 (1.4%)
29 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

15,250 (82.6%)
Required Intervention 965 (5.2%)
Other 832 (4.5%)
R 529 (2.9%)
Hospitalization 391 (2.1%)
Death 229 (1.2%)
L 121 (0.7%)
H 65 (0.4%)
Life Threatening 61 (0.3%)
O 9 (0.0%)
S 7 (0.0%)
Disability 5 (0.0%)

Yearly Trend

10
2010: 460
11
2011: 403
12
2012: 1,442
13
2013: 6,038
14
2014: 5,937
15
2015: 1,546
16
2016: 917
17
2017: 879
18
2018: 110
25
2025: 1