Intuitive Surgical

Explainers

Plain-language answers to the questions people ask about Intuitive Surgical, from DEPLOY’s explainer library. Each is written in the language of the question and cross-checked against this registry.

• What is a surgical robot?

  A surgical robot is a computer-assisted operative platform that places robotic arms, instruments, and visualization systems between the surgeon and the patient. The 2026 commercial cohort includes Intuitive Surgical (da Vinci + Ion; 11,395 + 1,041 systems installed per SEC 10-Q), Medtronic Hugo, CMR Surgical Versius, Asensus/Karl Storz Senhance, Stereotaxis Genesis, Distalmotion Dexter, Moon Surgical Maestro (ScoPilot is the cohort's genuine shipped surgical AI standout, FDA-cleared with a Predetermined Change Control Plan), and Brain Navi NaoTrac (autonomous registration, not tissue manipulation). J&J Ottava (De Novo submission January 2026) and Vicarious Surgical V1 remain pre-market research per DEPLOY's FDA-clearance-as-gating-event framework. The autonomy spectrum runs from teleoperated baseline through analytics AI to narrow autonomous registration; tissue-manipulation autonomy remains research demos on production hardware, not shipped product.

• What is Intuitive Surgical and the da Vinci surgical robot?

  Intuitive Surgical is the verified-at-scale anchor of the surgical robotics cohort. Per SEC 10-Q registry source-of-truth, installed base is 11,395 da Vinci systems + 1,041 Ion systems; the installed base dwarfs combined competitor installed base. da Vinci 5 was FDA-cleared March 2024 as the current product generation; Ion is a separate robotic-bronchoscopy product line. Architecture is teleoperated baseline with shipped analytics AI; autonomous suturing work on da Vinci hardware is research demos, not shipped product. Maturity: production. Per DEPLOY's framework, da Vinci is the gold standard verified deployment all other surgical entrants are measured against.

• How does DEPLOY track the 2026 da Vinci SureForm gray-reload Class I recall?

  DEPLOY tracks the [2026 da Vinci SureForm gray-reload Class I recall](https://registry.deploy.report/incidents/davinci-sureform-gray-reload-recall-death-2026) at primary-source-anchored FDA-recall-database verification depth as the surgical cohort's most severe verified incident. The substrate: 8mm SureForm 30 Gray reloads (2mm staples for extra-thin tissue) produced incomplete staple lines on blood vessels despite a 'completed' fire indication; customer letter / quarantine March 11, 2026; FDA classified Class I (reported May 2026); 1 death + 4 serious injuries (bleeding). Blue/white reloads UNAFFECTED at canonical within-product-family verification scope distinction. The framework reads the incident at four substrate layers simultaneously: incident-recall actuarial depth per Phase 3 Dim 1 (severity=critical at primary-source-anchored verification; cohort's most severe); within-entity verification scope at sub-product-line granularity (gray vs blue/white reload distinction is the within-da-Vinci feature-level verification posture distinct); regulatory clearance per jurisdiction at Dim 4 (FDA Class I primary-government-record sub-tier verification); year-discipline framework distinguishing the 2026 gray-reload recall from the 2022 SureForm fragment recall (Z-0340-2023; Class II; October 7, 2022) at year-class-failure-mode granularity. Cap-flag honest-absence at exact recall Z-number + unit count (not captured from primary FDA pages). Root cause stated 'still under investigation' at primary-source-anchored verification depth.

• How does DEPLOY track incident outcome_class and deployment exposure_hours at actuarial depth?

  DEPLOY tracks Phase 3 Dim 1 actuarial substrate at primary-source-anchored verification depth across two structurally-distinct axes simultaneously: incident numerator (outcome_class at 67 rows across 61 incidents; multi-class where evidenced; distribution skewed regulatory_action:34 + property_damage:18 + bodily_injury:7 + no_outcome:4 + financial_loss:2 + fatality:1 + near_miss:1) and deployment denominator (exposure_hours at canonical 128-nulls honest-absence; Agent A documented under-population over fabrication). The 128-nulls is the canonical worked example for 'honest absence at full-population scale beats partial fabrication.' Scalar selectivity tight per *_basis verified-vs-claimed discipline: 1 USD figure at primary-source-anchored verification depth (MQ-9 Reaper $32M reported_press gt_10m); 3 fatality_count rows; 5 bodily_injury_severity rows; 4 loss_cost_class rows; most NULL at honest-absence cap-flag. Cap-flag-as-trust-signal operates recursively at three substantive layers simultaneously: 128-null exposure_hours denominator (full-population honest-absence) + scalar selectivity at 1-of-61 USD verified ratio (extreme primary-source-anchored selectivity) + outcome distribution skew (no_outcome:4 documented as substantive editorial state, not as substrate-completeness gap). The framework operates at honesty-as-strength rather than coverage-as-strength: under-population at primary-source-anchored verification depth beats fabrication at marketing-aggregation depth. Rover's 5-commit Dim 1 surface work landed across all four axes (callable MCP tool + structured JSON-LD + human-facing /incidents page + REST aggregated endpoint); substrate is fully live and queryable.

• How does DEPLOY distinguish da Vinci safety events at year-class-failure-mode-product-variant granularity?

  DEPLOY tracks within-da-Vinci-product-family safety events at year-class-failure-mode-product-variant granularity per Agent A's surgical incidents substrate. The three canonical worked examples span distinct product lines + distinct years + distinct classes + distinct failure modes simultaneously: [2013 EndoWrist Hot Shears Class I recall](https://registry.deploy.report/incidents/davinci-hot-shears-burn-recall-2013) (May 8, 2013 Urgent Medical Device Notification; '-09'/'-10' versions; insulation micro-cracks near distal shaft after cleaning/sterilization create monopolar energy arc path; burn tissue outside surgical field; 134 tip-cover complaints + 82 MDRs Jan 2010-Dec 2011; remediated via instrument version supersession; load-bearing historical da Vinci safety event); [2022 SureForm fragment Class II recall](https://registry.deploy.report/incidents/davinci-sureform-stapler-fragment-recall-2022) (Z-0340-2023; October 7, 2022; da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads; intraoperative device-fragment generation; potential staple deployment failure); [2026 SureForm gray-reload Class I recall](https://registry.deploy.report/incidents/davinci-sureform-gray-reload-recall-death-2026) (March 11, 2026 customer letter + Class I reported May 2026; 8mm SureForm 30 Gray reloads; incomplete staple lines on blood vessels; 1 death + 4 serious injuries; cohort's most severe per [the 2026 gray-reload framework-in-action narrative](/explainers/how-deploy-tracks-the-2026-davinci-sureform-gray-reload-class-i-recall)). Plus adjacent [2013 FDA Warning Letter regulatory_action](https://registry.deploy.report/incidents/intuitive-fda-warning-letter-2013) (July 19, 2013; distinct from May 2013 device recall; reporting-compliance regulatory action; serious severity; cap-flag honest-absence at primary FDA letter direct retrieval). Aggregator coverage frequently collapses 'da Vinci recalls' across years; the framework distinguishes them structurally at four substrate axes simultaneously (year + class + failure mode + product variant) per [verified-vs-claimed at within-entity granularity methodology pillar](/explainers/verified-vs-claimed-within-entity).

Current leadership (3)

• Jaime Wong SVP & Chief Medical OfficerIR-verified
• Jamie Samath executiveSEC-verified
• David Rosa President & CEOsince 2025-04-01IR-verified

Founders (3)

• Frederic Mollcofounderfounded 1995-01-01no longer at company
• John Freundcofounderfounded 1995-01-01no longer at company
• Robert Youngecofounderfounded 1995-01-01no longer at company

Board (3)

• Gary Guthart chair
• Dave Rosa director
• Craig Barratt director

Former / Previously (4)

• Robert Younge Co-founder (first CTO)secondary-verified
• John Freund Co-foundersecondary-verified
• Gary Guthart CEO (2010-2025)IR-verified
• Frederic Moll Co-founder1995 to 2002secondary-verified

Safety record

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Incidents affecting Intuitive Surgical (51)

• Intuitive Surgical recalls da Vinci SP1098 instrument2026-06-22 · Recall
• Intuitive Surgical recalls 8mm SureForm 30 Gray Reloads after patient death2026-05-28 · Recall
• Intuitive Surgical recalls da Vinci staplers after death and injuries2026-04-15 · Recall
• Intuitive Surgical recalls da Vinci X and Xi Universal Surgical Manipulators over cannula mount screws that can break (FDA Z-2046-2026)2026-04-02 · Recall
• Sunnybrook study: robotic-assisted knee replacement associated with double the risk of major complications2026-04-01 · Other
• da Vinci 8mm SureForm 30 Gray stapler reload recall after incomplete staple lines (1 death, 4 serious injuries)2026-03-11 · Recall
• Intuitive recalls da Vinci 8mm SureForm 30 Gray Reloads (Class I) over incomplete staple lines2026-03-11 · Recall
• Intuitive Surgical recalled da Vinci SureForm 30 stapler gray reloads after incomplete staple lines caused 4 serious injuries and 1 death2026-03-11 · Recall
• FDA Class 2 recall: da Vinci 5 viewer display firmware issue causing loss of 3D surgical field2026-02-18 · Recall
• AJRC citizen petition (FDA-2026-P-1299) requests Class I recall of all da Vinci 5 systems over intraoperative power failure defect2026-02-04 · Regulatory action
• da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use2026-02-02 · Recall
• Intuitive Ion Endoluminal System recall: probe-bag sterile-seal issue (Z-1134-2026)2026-01-28 · Recall
• Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures2026-01-26 · Regulatory action
• Intuitive recalls da Vinci SP Access Port Kit over trays that can crack and breach sterility2025-12-15 · Recall
• Intuitive recalls da Vinci S/Si Mega Needle Driver over broken or frayed grip cables2025-12-09 · Recall
• Intuitive recalls da Vinci S/Si Permanent Cautery Hook over frayed or broken pitch cables2025-12-09 · Recall
• da Vinci X/Xi/5 recall: software error let instrument arms failing a ball-screw diagnostic stay in use2025-11-07 · Recall

  via da Vinci (and Ion)

• Intuitive recalls da Vinci X/Xi and da Vinci 5 software that left failed-diagnostic arms available for clinical use2025-11-07 · Recall
• da Vinci SP: patient experienced abdominal pain, bleeding, and wound infection (FDA MAUDE)2025-06-18 · Injury
• da Vinci 5 console foot-pedal recall over a spring failure that can leave a pedal stuck pressed2025-02-26 · Recall
• da Vinci endoscope: light left on burned the patient after resting on the thigh (FDA MAUDE)2025-01-21 · Injury
• Intuitive recalls da Vinci Monopolar Curved Scissors over frayed/broken grip cables causing loss of instrument control2024-12-19 · Recall
• Intuitive recalls da Vinci 8mm Horizon Small Clip Applier over frayed or broken grip cables2024-12-19 · Recall
• Intuitive recalls da Vinci 8mm ProGrasp Forceps over frayed or broken grip cables2024-12-19 · Recall
• Intuitive recalls da Vinci 8mm Mega SutureCut Needle Driver over frayed or broken grip cables2024-12-19 · Recall
• Intuitive recalls da Vinci 8mm Large Needle Driver over frayed or broken grip cables2024-12-19 · Recall
• Intuitive Ion Endoluminal System recall: instrument-cart-arm screw issue (Z-2720-2024)2024-09-04 · Recall
• Intuitive recalls da Vinci Single-Site Wristed Needle Driver over dislodging or breakage causing uncontrolled movement2023-10-06 · Recall
• Intuitive recalls da Vinci Tip-Up Fenestrated Grasper over grip breakage that can drop steel fragments into patients2023-06-12 · Recall
• da Vinci X/Xi recall: loose instrument carriage from an out-of-spec linear-rail component2023-02-23 · Recall
• da Vinci Xi 8mm SureForm 30 stapler recall over staple-deployment failure and device fragments2022-10-07 · Recall
• Intuitive recalls da Vinci X/Xi systems over inadvertent energy delivery with Force bipolar instruments2022-09-20 · Recall
• Intuitive recalls da Vinci X/Xi and S/Si Clip Appliers over unexpected motion from partial disengagement2022-07-01 · Recall
• Intuitive recalls da Vinci X/Xi SureForm 45 staplers over tissue pushout that can cause critical bleeding2022-03-17 · Recall
• Intuitive recalls da Vinci SynchroSeal instruments over risk of insufficient vessel seals2022-03-03 · Recall
• Intuitive recalls da Vinci EndoWrist Vessel Sealer Extend instruments over risk of insufficient vessel seals2022-03-03 · Recall
• Intuitive recalls da Vinci Xi/X Conductive Cannula Reducer over metal tip that can dislodge inside patients2021-12-23 · Recall
• Intuitive recalls Ion Flexision 19G Biopsy Needle over a sheath tip that can separate from the shaft2021-08-06 · Recall
• Intuitive Ion Endoluminal System recalls (fully-articulating catheter and Flexison biopsy needle)2020-12-02 · Recall
• Intuitive recalls Ion Fully Articulating Catheter over a distal tip ring that can become dislodged2020-10-23 · Recall
• Intuitive recalls Ion Catheter Reprocessing Cover over disengagement that can retain cleaning chemicals2020-06-10 · Recall
• Intuitive recalls da Vinci X and Xi systems over defective capacitors that can cause vision loss or system errors2019-07-26 · Recall
• Intuitive recalls da Vinci 8mm Monopolar Curved Scissors over extension-tube cracks that can drop fragments into patients2018-08-15 · Recall
• Intuitive recalls da Vinci X systems over a high rate of ACJ board failure2018-03-07 · Recall
• Intuitive recalls da Vinci Xi EndoWrist Suction Irrigator over unexpected arm motion in specific software scenarios2017-03-31 · Recall
• Intuitive recalls da Vinci EndoWrist Stapler 45 over increased Stapler Firing Failed complaints2016-07-14 · Recall
• Intuitive recalls da Vinci 30-degree 8mm Endoscope over risk of patient harm from monopolar energy2015-11-23 · Recall
• Intuitive recalls da Vinci Fundus Grasper over jaws that can become stuck closed2015-08-08 · Recall
• FDA warning letter to Intuitive Surgical over late reporting of da Vinci corrections and adverse events2013-07-19 · Regulatory action
• da Vinci Hot Shears (monopolar curved scissors) Class I recall: insulation micro-cracks caused tissue burns2013-05-08 · Recall
• Intuitive recalls da Vinci 8mm Maryland Bipolar Forceps over a cautery plug insert that can dislodge2013-05-08 · Recall

Includes incidents linked directly to this company, to its models, or to deployments of its models or under its operation. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Peer companies

• Johnson & Johnson3 models
• LEM Surgical2 models
• MicroPort MedBot2 models
• Neocis2 models
• Stryker2 models
• Vantis2 models

Supplied by (1)

Inbound supply edges feeding this company directly or via the models it owns. Same source bar as the outbound view (verified against at least two strong sources).

Financial state

Reporting period

2024-01-01 to 2024-12-31

Reporting basis

sec_10k

Revenue disclosed

$8352100000 (sec_10k)

Lifecycle stage

mature

Counterparty risk class

low

SEC filing

10-K

Each numeric field carries its own basis marker. Aggregators report a number; this surface preserves the source class so verification depth travels with the value.

Regulatory filings (16)

• fda_recallfda recall · us_fdasuperseded
• Z-1232-2026fda recall · us_fdarecalled

  Linked models: da Vinci (and Ion)

• Z-1262-2023fda recall · us_fdarecalled

  Linked models: da Vinci (and Ion)

• Z-0340-2023fda recall · us_fdarecalled

  Linked models: da Vinci (and Ion)

• Z-1855-2026fda recall · us_fdarecalled2026-03-11

  Linked models: da Vinci (and Ion)

• Z-1134-2026fda recall · us_fdarecalled2025-12-04

  Linked models: Ion Endoluminal System

• Z-1325-2025fda recall · us_fdarecalled2025-02-26

  Linked models: da Vinci (and Ion)

• Z-2720-2024fda recall · us_fdarecalled2024-07-12

  Linked models: Ion Endoluminal System

• K232610fda 510k · us_fdacleared2023-08-28reported

  Linked models: da Vinci (and Ion)

• Z-0106-2022fda recall · us_fdarecalled2021-08-06

  Linked models: Ion Endoluminal System

• Z-0489-2021fda recall · us_fdarecalled2020-10-23

  Linked models: Ion Endoluminal System

• K182188fda 510k · us_fdacleared2018-08-13

  Linked models: Ion Endoluminal System

• fda_warning_letterfda warning letter · us_fdaclosed2013-07-16

  Linked models: da Vinci (and Ion)

• Z-1442-2013fda recall · us_fdarecalled2013-05-08

  Linked models: da Vinci (and Ion)

• fda_510kfda 510k · us_fdacleared2000-01-01

  Linked models: da Vinci (and Ion)

• K990144fda 510k · us_fdacleared1999-01-19

  Linked models: da Vinci (and Ion)

Patent estate (3)

• US12575898B2usptograntedassignee
• US12520995B2usptograntedassignee
• US12446982B2usptograntedassignee

Patent litigations (4)

• 1:18-cv-01359district_courtsettled · settled undisclosedas complainant2023-01-01
• 3:21-cv-03496district_courtdecided · no infringementas respondent2024-01-28
• 8:20-cv-02274district_courtsettled · settled undisclosedas respondent2022-09-01
• 5:19-cv-00055district_courtsettled · settled undisclosedas respondent2023-01-27

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

• Incident recordedJun 22, 2026

  Intuitive Surgical recalls da Vinci SP1098 instrument

• Verified media added✓VerifiedJun 8, 2026

  Navigating emergency care with da Vinci surgery

• Verified media added✓VerifiedJun 5, 2026

  Introducing Ion by Intuitive

• Verified media added✓VerifiedJun 5, 2026

  da Vinci SP single-incision surgery

• Verified media added✓VerifiedJun 5, 2026

  da Vinci SP single-port system

Full change history →

Sources (4)

1. https://www.sec.gov/Archives/edgar/data/0001035267/000103526726000032/isrg-20260331.htm ↗
2. https://www.sec.gov/Archives/edgar/data/1035267/000103526726000029/q126ex-991earningsrelease.htm ↗
3. https://www.globenewswire.com/news-release/2024/03/14/2846718/7637/en/Intuitive-Announces-FDA-Clearance-of-Fifth-Generation-Robotic-System-da-Vinci-5.html ↗
4. https://www.therobotreport.com/intuitive-demos-4000-mile-telesurgery-with-da-vinci-5-surgical-robot/ ↗

Common questions

What is Intuitive Surgical?

Dominant surgical-robotics maker (NASDAQ: ISRG; founded 1995, Sunnyvale CA) of the da Vinci teleoperated surgical robots and the Ion robotic bronchoscopy system; 11,000+ da Vinci installed worldwide.

What does Intuitive Surgical make?

Intuitive Surgical has 2 robot models on the DEPLOY registry: Ion Endoluminal System, da Vinci (and Ion) (Intuitive Surgical builds both physical robots and the AI that runs them).

Is Intuitive Surgical publicly traded?

Yes. Intuitive Surgical is publicly traded on public markets, per the DEPLOY registry.

Who competes with Intuitive Surgical?

On the DEPLOY registry, peer companies to Intuitive Surgical building in the same form factors include Johnson & Johnson, LEM Surgical, MicroPort MedBot, Neocis.

Who is the CEO of Intuitive Surgical?

David Rosa is the ceo of Intuitive Surgical, per the DEPLOY registry.