{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2026-04232", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260213", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20251107", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20260213", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250508", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "397857", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260213", "brand_name": "DA VINCI ENERGY", "generic_name": "SYNCHROSEAL", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480440-06", "catalog_number": "480440", "lot_number": "K12250508 0045", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(10)K12250508", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "03/16/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260213", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20260403", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24337376", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260121", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "397407824", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "397407825", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SYNCHROSEAL WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT WAS RETURNED WITH A MISSING INTEGRATED CORD. VISUAL INSPECTION DID NOT REVEAL ANY THERMAL DAMAGE OR SIGNS OF \"MELTING\". THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. NO ERRORS WERE FOUND IN THE LOGS. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE THE JAW COVER TORN. THE TEARS MEASURED ROUGHLY 0.1315\" X 0.0910\". THE JAW COVER TORN AND THERE MAY BE MISSING PIECES, BUT THE SIZE OF THE MISSING PIECES CANNOT BE CONFIRMED. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS." }, { "mdr_text_key": "393115685", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "393115686", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL DID NOT CUT TISSUE AND \"DISINTEGRATED\" DURING USE. A FRAGMENT FELL INSIDE OF THE PATIENT AND WAS NOT RETRIEVED. THE PROCEDURE WAS COMPLETED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/03/2026" } ] }