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Field safety notice for Hugo surgeon console power supply failure

S2 · · Medtronic Hugo

Record

CompanyMedtronic Hugo
Categorymedical robotics
Typemalfunction
Date
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS2 (minor injury or single-unit damage)
Scale25 complaints, subset of Hugo consoles in Europe
Confidencemedium
VerificationCited source on file; not independently re-verified
SourceMassDevice

What happened

Medtronic issued an urgent field safety notice in Europe (also filed with German and Irish regulators) after 25 complaints of power supply failure in the Hugo RAS surgeon console, which could cause permanent loss of the ability to teleoperate the system before or during a procedure; Medtronic reported zero instances of serious patient harm and continued use was deemed appropriate pending inspection/servicing.

Medtronic Hugo record context

Entries by year and severity

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S1S2S3S4S5

By incident type

By severity

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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
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medical robotics: failure modes

medical robotics: most entries

malfunction context

malfunction: by category

malfunction: by year

malfunction: severity profile

Comparable malfunction events in medical robotics

SevDateCompanyEvent
S12026-03Keenon RoboticsRestaurant service robot malfunctions, scatters tableware
S32025Intuitive Surgical2015-2025 MAUDE study finds continued adverse event rate in da Vinci procedures
S32024-05-08NeuralinkNeuralink brain implant threads retract in first human patient
S42021-09Intuitive SurgicalLawsuit: da Vinci surgical robot burned woman's small intestine
S42013Intuitive Surgical14-year FDA MAUDE analysis finds 144 deaths, 1,391 injuries in robotic surgery (2000-2013)
S4Intuitive SurgicalNBC News 10-year MAUDE analysis of da Vinci adverse events

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