{ "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": "2955842-2026-21288", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260414", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20260323", "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": "SW", "manufacturer_contact_area_code": "", "date_added": "20260414", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251016", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "937860", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260414", "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": "480440-07", "catalog_number": "480440", "lot_number": "K10251016", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "10886874117306", "udi_public": "(01)10886874117306(17)271031(10)K10251016", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "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": "20260414", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "42 YR", "patient_sex": "Unknown", "patient_weight": "120 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260414", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24879429", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20260323", "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": "398424389", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE DURING A KIDNEY OPERATION, THE CUSTOMER WAS PLACING THE SPECIMEN IN THE SPECIMEN BAG. THEN THE OPERATOR DISCOVERS A SMALL METAL RING/RUBBER RING LOOSE IN THE ABDOMEN AND WONDERS WHAT THIS WAS. THE CUSTOMER CHECKED THE ROBOTIC INSTRUMENTS AND CONCLUDED THAT THE SMALL RING COMES FROM THE SYNCHROSEAL. THE METAL RING WAS TAKEN OUT AND THE SYNCHROSEAL WAS SAVED FOR A COMPLAINT TO INTUITIVE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO ABNORMALITIES WERE NOTED. AFTER APPROXIMATELY TWO HOURS OF USE DURING A NEPHRECTOMY INVOLVING A LARGE KIDNEY AND SUBSTANTIAL SURROUNDING TISSUE, THE SURGEON REPORTED THE BREAKAGE ISSUE, BELIEVING IT STEMMED FROM AN INTERNAL PROBLEM WITH THE INSTRUMENT ITSELF. ALTHOUGH THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS DURING THE PROCEDURE, NO ISSUES WITH ITS FUNCTIONALITY WERE OBSERVED, AND NO FRAGMENTS FELL INSIDE THE PATIENT. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE AS ONLY THE SPECIMEN PLACEMENT REMAINED. NO POST-OPERATIVE IMAGING WAS PERFORMED TO CHECK FOR FRAGMENTS, AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT NEED FOR CONVERSION. THE PATIENT HAS NOT RETURNED WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FRAGMENTS. THE INSTRUMENT AND FRAGMENT ARE SCHEDULED TO BE COLLECTED FOR EVALUATION, AND PHOTOGRAPHIC AND VIDEO DOCUMENTATION ARE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "398424390", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE SYNCHROSEAL INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." } ], "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": "" } ] }