RobotRisk Autonomous Systems Incident & Risk Register
RobotRisk / Intuitive Surgical / 2026-05
medical robotics · injury

MAUDE injury report 2955842-2026-23859 (da Vinci)

S3 · 05/2026 · Intuitive Surgical

Record

CompanyIntuitive Surgical
Categorymedical robotics
Typeinjury
Date05/2026
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleMDR 2955842-2026-23859
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceopenFDA MAUDE

What happened

UPDATED: H10, D9, G6, H1, H2, H3, ANNEX C, D, G. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT (PART NUMBER: 430004-53/LOT NUMBER: S10190926/0003) WAS ANALYZED AND FOUND TO HAVE TIP DETECT

Intuitive Surgical record context

Entries by year and severity

2374742020 S3: 842020 S5: 387202021 S3: 1292021 S4: 12021 S5: 3133212022 S3: 1202022 S5: 10130222023 S3: 1882023 S5: 2190232024 S3: 2452024 S5: 7252242025 S3: 4702025 S5: 4474252026 S3: 3812026 S5: 838926
S1S2S3S4S5

By incident type

By severity

Intuitive Surgical vs medical robotics alternatives

medical robotics context

medical robotics: entries by year

2545082015 S2: 12015 S3: 12152016 S3: 32016 S4: 14162017 S4: 11172018 S2: 12018 S3: 12182019 S3: 33192020 S3: 1052020 S5: 3108202021 S3: 1642021 S4: 12021 S5: 3168212022 S2: 12022 S3: 1352022 S5: 10146222023 S3: 2222023 S5: 2224232024 S3: 2692024 S5: 7276242025 S3: 5042025 S5: 4508252026 S1: 12026 S2: 12026 S3: 4262026 S4: 52026 S5: 844126
S1S2S3S4S5

medical robotics: failure modes

medical robotics: most entries

injury context

injury: by category

injury: by year

injury: severity profile

Comparable injury events in medical robotics

SevDateCompanyEvent
S22015-06-30HocomaProximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training

Other Intuitive Surgical entries

Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs