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Industry · Medical robotics

Intuitive Surgical

Robot types: Endoluminal, Surgical robot. Risk band: High   RobotRisk index 72.6/100 (severity- and time-weighted incidents) · ranked 1 of 25 among Medical robotics companies with incidents (274 tracked).

Analyst brief

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

72.6/100RobotRisk index
21.8/100Median index across the 25 Medical robotics companies with incident history (274 tracked, 249 with none)
1 of 25Rank in Medical robotics (of 25 with incident history)
HighRisk band

Products and robot types

Industries: Medical robotics · Sectors: Hospitals and Health Care

Risk is scored per product and robot type: each incident is attributed to the product it names, or to the company's matching robot type.

Robot typeShare of company riskRank within type
Surgical robot100%1 of 8
ProductRobot typeStatusIncidentsIndex
SureForm staplers & EndoWrist instruments Surgical robotshipping00.0
Ion Endoluminalga00.0
da Vinci 5 Surgical robotga872.6
da Vinci SP Surgical robotga00.0

Incident timeline

Comparisons over time

Per-type breakdown

Incident typeUnique incidentsShare
malfunction450%
recall338%
regulatory112%

Unique incident list

8 unique incidents on file for this company.

SevDateTypeLocationIncidentSource
S418 Mar 2026 regulatory USAFDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries HealthExec
S511 Mar 2026 recall —Class I recall of da Vinci SureForm stapler reloads after patient death · 1 death, 4 serious injuries; recall of affected lot to customers who ordered on/before Feb 20, 2026 FDA
S326 Feb 2025 recall —Class II recall of da Vinci 5 foot pedal over spring failure · da Vinci 5 systems, foot pedal component MassDevice
S3~2025 malfunction —2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures · 420.1 reports per 100,000 procedures; 3.1 deaths per 100,000 procedures, aggregate MAUDE data, most recent decade Journal of Robotic Surge
S319 Dec 2024 recall —Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying · multiple instrument models, US and international distribution MedTech Dive
S4~Sep 2021 malfunction FL, USALawsuit: da Vinci surgical robot burned woman's small intestine NBC News
S419 Dec 2018 malfunction —NBC News 10-year MAUDE analysis of da Vinci adverse events · 20,000+ adverse events, 274 deaths, 2,000+ injuries, 17,000 malfunctions, aggregate MAUDE data NBC News
S4~2013 malfunction —14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013) · 144 deaths, 1,391 injuries, 8,061 malfunctions over 14 years, aggregate MAUDE data PLOS One
S4 18 Mar 2026 · regulatory · FDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries
USA1 supporting source rowhigh confidence
SevDateSupporting source rowSource
S418 Mar 2026FDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuriesHealthExec
S5 11 Mar 2026 · recall · Class I recall of da Vinci SureForm stapler reloads after patient death
Location not specified1 supporting source rowhigh confidence
SevDateSupporting source rowSource
S511 Mar 2026Class I recall of da Vinci SureForm stapler reloads after patient deathFDA
S3 26 Feb 2025 · recall · Class II recall of da Vinci 5 foot pedal over spring failure
Location not specified1 supporting source rowmedium confidence
SevDateSupporting source rowSource
S326 Feb 2025Class II recall of da Vinci 5 foot pedal over spring failureMassDevice
S3 ~2025 · malfunction · 2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures
Location not specified1 supporting source rowhigh confidence
SevDateSupporting source rowSource
S3~20252015-2025 MAUDE study finds continued adverse event rate in da Vinci proceduresJournal of Robotic Surge
S3 19 Dec 2024 · recall · Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable fraying
Location not specified1 supporting source rowmedium confidence
SevDateSupporting source rowSource
S319 Dec 2024Class II recall of da Vinci reusable instruments (forceps, scissors, drivers, graspers) over cable frayingMedTech Dive
S4 ~Sep 2021 · malfunction · Lawsuit: da Vinci surgical robot burned woman's small intestine
FL, USA1 supporting source rowmedium confidence
SevDateSupporting source rowSource
S4~Sep 2021Lawsuit: da Vinci surgical robot burned woman's small intestineNBC News
S4 19 Dec 2018 · malfunction · NBC News 10-year MAUDE analysis of da Vinci adverse events
Location not specified1 supporting source rowhigh confidence
SevDateSupporting source rowSource
S419 Dec 2018NBC News 10-year MAUDE analysis of da Vinci adverse eventsNBC News
S4 ~2013 · malfunction · 14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)
Location not specified1 supporting source rowhigh confidence
SevDateSupporting source rowSource
S4~201314-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)PLOS One

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