{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:32:38Z","timestamp":1787239958500,"version":"build-2736575974"},"reference-count":30,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Robotic Surg"],"DOI":"10.1007\/s11701-026-03818-3","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T02:17:23Z","timestamp":1787192243000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Failure modes in soft-tissue surgical robots: an adjudicated FDA recall cohort, 2005\u20132026"],"prefix":"10.1007","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2627-298X","authenticated-orcid":false,"given":"Rafa\u0142 Bogdan","family":"Drobot","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,20]]},"reference":[{"key":"3818_CR1","unstructured":"U.S. Food and Drug Administration (2026) Computer-assisted surgical systems. https:\/\/www.fda.gov\/medical-devices\/surgery-devices\/computer-assisted-surgical-systems. Accessed 19 July 2026"},{"key":"3818_CR2","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1038\/s41591-023-02732-7","volume":"30","author":"HJ Marcus","year":"2024","unstructured":"Marcus HJ, Ramirez PT, Khan DZ et al (2024) The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring. Nat Med 30:61\u201375. https:\/\/doi.org\/10.1038\/s41591-023-02732-7","journal-title":"Nat Med"},{"key":"3818_CR3","unstructured":"U.S. Food and Drug Administration (2026) Total product life cycle for medical devices. https:\/\/www.fda.gov\/about-fda\/cdrh-transparency\/total-product-life-cycle-medical-devices. Accessed 19 July 2026"},{"key":"3818_CR4","unstructured":"U.S. Food and Drug Administration (2026) About Manufacturer and User Facility Device Experience (MAUDE) Database. . Accessed 19 July 2026 https:\/\/www.fda.gov\/medical-devices\/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities\/about-manufacturer-and-user-facility-device-experience-maude-database"},{"key":"3818_CR5","doi-asserted-by":"publisher","first-page":"e0151470","DOI":"10.1371\/journal.pone.0151470","volume":"11","author":"H Alemzadeh","year":"2016","unstructured":"Alemzadeh H, Raman J, Leveson N, Kalbarczyk Z, Iyer RK (2016) Adverse events in robotic surgery: a retrospective study of 14 years of FDA data. PLoS ONE 11:e0151470. https:\/\/doi.org\/10.1371\/journal.pone.0151470","journal-title":"PLoS ONE"},{"key":"3818_CR6","doi-asserted-by":"publisher","first-page":"179","DOI":"10.1007\/s11701-020-01088-1","volume":"15","author":"H Pierce","year":"2021","unstructured":"Pierce H, Roberts B, Scherr D et al (2021) Patient injuries and malfunctions associated with robotic prostatectomy: review of the manufacturer and user facility device experience database. J Robot Surg 15:179\u2013185. https:\/\/doi.org\/10.1007\/s11701-020-01088-1","journal-title":"J Robot Surg"},{"key":"3818_CR7","doi-asserted-by":"publisher","first-page":"348","DOI":"10.1007\/s00345-025-05732-z","volume":"43","author":"NM Buffi","year":"2025","unstructured":"Buffi NM, Piccolini A, Moretto S et al (2025) Reliability of the da Vinci robotic surgical system: a systematic review and pooled analysis of technical failures. World J Urol 43:348. https:\/\/doi.org\/10.1007\/s00345-025-05732-z","journal-title":"World J Urol"},{"key":"3818_CR8","doi-asserted-by":"publisher","first-page":"628","DOI":"10.1016\/j.eururo.2025.06.014","volume":"88","author":"M Paciotti","year":"2025","unstructured":"Paciotti M, Piccolini A, Uleri A et al (2025) Robotic surgery and patient safety: a global assessment of technological malfunctions during da Vinci X and Xi procedures. Eur Urol 88:628\u2013629. https:\/\/doi.org\/10.1016\/j.eururo.2025.06.014","journal-title":"Eur Urol"},{"key":"3818_CR9","doi-asserted-by":"publisher","first-page":"72","DOI":"10.1007\/s11701-025-02947-5","volume":"20","author":"TY Hsieh","year":"2026","unstructured":"Hsieh TY, Huang KH (2026) Adverse events and device malfunctions in da Vinci robotic surgery: an analysis of MAUDE data from the recent decade. J Robot Surg 20:72. https:\/\/doi.org\/10.1007\/s11701-025-02947-5","journal-title":"J Robot Surg"},{"key":"3818_CR10","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1007\/s11701-026-03378-6","volume":"20","author":"BM Hammadeh","year":"2026","unstructured":"Hammadeh BM, Hussein AM, Alhamwi N, Mohammad AK, Ghanem R (2026) Device malfunctions and patient harm in robotic-assisted prostatectomy: a 17-year review of the FDA MAUDE database. J Robot Surg 20:420. https:\/\/doi.org\/10.1007\/s11701-026-03378-6","journal-title":"J Robot Surg"},{"key":"3818_CR11","unstructured":"U.S. Food and Drug Administration (2025) Recalls, corrections and removals (devices). . Accessed 19 July 2026 https:\/\/www.fda.gov\/medical-devices\/postmarket-requirements-devices\/recalls-corrections-and-removals-devices"},{"key":"3818_CR12","unstructured":"U.S. Food and Drug Administration (2026) Medical Device Recalls Database. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfres\/res.cfm. Accessed 19 July 2026"},{"key":"3818_CR13","unstructured":"openFDA (2026) Device recalls: data and application programming interface. https:\/\/open.fda.gov\/data\/device-recall\/. Accessed 19 July 2026"},{"key":"3818_CR14","doi-asserted-by":"publisher","first-page":"1499","DOI":"10.7326\/ANNALS-24-00724","volume":"177","author":"C See","year":"2024","unstructured":"See C, Mooghali M, Dhruva SS, Ross JS, Krumholz HM, Kadakia KT (2024) Class I recalls of cardiovascular devices between 2013 and 2022. Ann Intern Med 177:1499\u20131508. https:\/\/doi.org\/10.7326\/ANNALS-24-00724","journal-title":"Ann Intern Med"},{"key":"3818_CR15","unstructured":"U.S. Food and Drug Administration (2026) Cybersecurity in medical devices: quality management system considerations and content of premarket submissions. Guidance for industry and Food and Drug Administration staff. Issued 3 February 2026. . Accessed 2 August 2026 https:\/\/www.fda.gov\/media\/119933\/download"},{"key":"3818_CR16","doi-asserted-by":"publisher","first-page":"1453","DOI":"10.1016\/S0140-6736(07)61602-X","volume":"370","author":"E von Elm","year":"2007","unstructured":"von Elm E, Altman DG, Egger M, Pocock SJ, G\u00f8tzsche PC, Vandenbroucke JP (2007) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet 370:1453\u20131457. https:\/\/doi.org\/10.1016\/S0140-6736(07)61602-X","journal-title":"Lancet"},{"key":"3818_CR17","doi-asserted-by":"publisher","first-page":"160018","DOI":"10.1038\/sdata.2016.18","volume":"3","author":"MD Wilkinson","year":"2016","unstructured":"Wilkinson MD, Dumontier M, Aalbersberg IJJ et al (2016) The FAIR Guiding Principles for scientific data management and stewardship. Sci Data 3:160018. https:\/\/doi.org\/10.1038\/sdata.2016.18","journal-title":"Sci Data"},{"key":"3818_CR18","unstructured":"U.S. Food and Drug Administration (2024) K232610: da Vinci Surgical System Model IS5000. Accessed 19 July 2026 https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf23\/K232610.pdf"},{"key":"3818_CR19","unstructured":"U.S. Food and Drug Administration (2024) K233866: Senhance Surgical System. Accessed 19 July 2026 https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf23\/K233866.pdf"},{"key":"3818_CR20","unstructured":"U.S. Food and Drug Administration (2024) DEN230025: MIRA Surgical System. Accessed 19 July 2026 https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf23\/DEN230025.pdf"},{"key":"3818_CR21","unstructured":"U.S. Food and Drug Administration (2024) DEN230078: Versius Surgical System. Accessed 19 July 2026 https:\/\/www.accessdata.fda.gov\/cdrh_docs\/reviews\/DEN230078.pdf"},{"key":"3818_CR22","unstructured":"U.S. Food and Drug Administration (2025) K250725: Hugo RAS System. Accessed 19 July 2026 https:\/\/www.accessdata.fda.gov\/cdrh_docs\/pdf25\/K250725.pdf"},{"key":"3818_CR23","unstructured":"U.S. Food and Drug Administration (2025) DEN230084: Dexter L6 Surgical System. Accessed 19 July 2026 https:\/\/www.accessdata.fda.gov\/cdrh_docs\/reviews\/DEN230084.pdf"},{"key":"3818_CR24","unstructured":"Food US, Administration D (2025) Class 1 Device Recall Asensus, event 93129, recall Z-0170-2024. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm?id=203513. Accessed 19 July 2026"},{"key":"3818_CR25","unstructured":"Food US, Administration D (2026) Class 1 Device Recall Intuitive Surgical 8\u00a0mm SureForm 30 Gray Reloads, event 98525, recall Z-1855-2026. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm?id=218985. Accessed 19 July 2026"},{"key":"3818_CR26","unstructured":"Food US, Administration D (2025) Class 2 Device Recall MIRA Surgical System, event 96831, recall Z-1905-2025. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm?id=213740. Accessed 19 July 2026"},{"key":"3818_CR27","unstructured":"Food US, Administration D (2026) Class 2 Device Recall Versius Surgical System US, event 99280, recall Z-2717-2026. https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm?id=221187. Accessed 19 July 2026"},{"key":"3818_CR28","unstructured":"Therapeutic Goods Administration (2025) Database of Recalls, Product Alerts and Product Corrections (DRAC). https:\/\/www.tga.gov.au\/safety\/recalls-and-other-market-actions\/database-recalls-product-alerts-and-product-corrections-drac. Accessed 2 August 2026"},{"key":"3818_CR29","unstructured":"Health Canada (2026) Find recalls, advisories and safety alerts. https:\/\/recalls-rappels.canada.ca\/en. Accessed 2 August 2026"},{"key":"3818_CR30","unstructured":"U.S. Government Accountability Office (2025) Medical device recalls: HHS and FDA should address limitations in oversight of recall process. GAO-26-107619. https:\/\/www.gao.gov\/products\/gao-26-107619. Accessed 19 July 2026"}],"container-title":["Journal of Robotic Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11701-026-03818-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11701-026-03818-3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11701-026-03818-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:12:30Z","timestamp":1787238750000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11701-026-03818-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,20]]},"references-count":30,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["3818"],"URL":"https:\/\/doi.org\/10.1007\/s11701-026-03818-3","relation":{},"ISSN":["1863-2491"],"issn-type":[{"value":"1863-2491","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,20]]},"assertion":[{"value":"19 July 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"5 August 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 August 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Financial interests: the author declares no financial interests relevant to this work. Non-financial interests: R.B.D. is a certified da Vinci console surgeon and an affiliate member of the EAU Young Academic Urologists Robotics in Urology Working Group. These roles did not influence eligibility, adjudication, analysis, or reporting.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study used public regulatory records and involved no human participants, identifiable private information, or animals. Institutional ethics approval was not required.","order":2,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":3,"name":"Ethics","label":"Consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":4,"name":"Ethics","label":"Consent to publish","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"No generative artificial intelligence or AI-assisted technologies were used in the design or conduct of the study, data acquisition or analysis, interpretation of the results, or preparation, writing, or editing of this manuscript. The author assumes full responsibility for the accuracy and integrity of the work.","order":5,"name":"Ethics","label":"Use of generative artificial intelligence","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"860"}}