RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk › Products › da Vinci 5
Product · Surgical robot · Intuitive Surgical

da Vinci 5

Next-generation surgical system. RobotRisk product index 72.6/100 from 8 attributed incidents (company index 72.6).

CompanyIntuitive Surgical
Robot typeSurgical robot (Medical & surgical robots)
Statusga · since 2024
SectorsHospitals and Health Care
S4+ incidents5

Incidents attributed to da Vinci 5

8 of 8 incidents
SevDateCompanyTypeLocationIncidentSource
S418 Mar 2026Intuitive Surgical regulatory USAFDA issues emergency alert on da Vinci-compatible surgical stapler reloads after 1 death, 4 injuries HealthExec
S511 Mar 2026Intuitive Surgical 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 2025Intuitive Surgical recall —Class II recall of da Vinci 5 foot pedal over spring failure · da Vinci 5 systems, foot pedal component MassDevice
S3~2025Intuitive Surgical 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 2024Intuitive Surgical 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 2021Intuitive Surgical malfunction FL, USALawsuit: da Vinci surgical robot burned woman's small intestine NBC News
S419 Dec 2018Intuitive Surgical 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
S4~2013Intuitive Surgical 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

Other Intuitive Surgical products

ProductRobot typeStatusIncidentsIndex
da Vinci SP Surgical robotga00.0
Ion Endoluminalga00.0
SureForm staplers & EndoWrist instruments Surgical robotshipping00.0

Other Surgical robot products

ProductCompanyRobot typeStatusIncidentsIndex
MIRAVirtual Incision Surgical robotshipping128.5
AquaBeamProcept BioRobotics Surgical robotshipping222.1
SenhanceAsensus Surgical Surgical robotga121.8
VersiusCMR Surgical Surgical robotga121.8
XACT ACEXACT Robotics Surgical robotshipping117.3
Hugo RASMedtronic Hugo Surgical robotga114.7
DexterDistalmotion Surgical robotearly-access00.0
SureForm staplers & EndoWrist instrumentsIntuitive Surgical Surgical robotshipping00.0
TomoTherapy / RadixactAccuray Surgical robotshipping00.0
Vicarious Surgical 9Vicarious Surgical Surgical robotearly-access00.0
da Vinci SPIntuitive Surgical Surgical robotga00.0
Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs