{"id":"72800768-0a3f-4135-ab5d-b31e17b2292f","slug":"fda-warning-letter-intuitive-2013","filingNumber":null,"filingType":"fda_warning_letter","jurisdiction":"us_fda","applicantCompanyId":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","filingDate":"2013-07-16T12:00:00.000Z","decisionDate":null,"status":"closed","clearanceScope":"FDA Warning Letter to Intuitive Surgical (2013) over late / inadequate reporting of da Vinci device corrections and adverse events.","sources":[{"url":"https://www.fda.gov/medical-devices/warning-letters","title":"FDA Warning Letter - Intuitive Surgical (2013)","sourceName":"FDA (primary)"}],"verificationPosture":"verified","capFlagNotes":"Issuance date 2013-07-16 per press citing the FDA letter (original 2013 letter de-listed from the live FDA database).","relatedIncidentId":"bb9555eb-07c7-43b9-bda2-08b08c7f0352","reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:17:13.499Z","updatedAt":"2026-06-05T15:35:55.698Z","applicantCompany":{"id":"e5127536-0ff2-4f0e-8488-64994cb2ffc7","slug":"intuitive-surgical","name":"Intuitive Surgical"},"modelLinks":[{"id":"4030b67a-cec2-421f-8d1e-d1f96605b8a9","modelId":"45105ba4-1c1f-4121-9ad4-bb912db1dcfc","regulatoryFilingId":"72800768-0a3f-4135-ab5d-b31e17b2292f","createdAt":"2026-06-04T23:17:13.659Z","model":{"slug":"intuitive-da-vinci","modelName":"da Vinci (and Ion)"}}]}