{ "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": "2955842-2026-00476", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260108", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20251211", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20260108", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250617", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "70073", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260108", "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": "K11250617 0105", "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(17)270630(10)K11250617", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Seal" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/22/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260209", "health_professional": "Y", "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": "20260108", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20260126", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24006104", "removal_correction_number": "ISIFA2022-01-C", "number_devices_in_event": "", "date_manufacturer_received": "20251211", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other", "Notification" ], "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": "391376423", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SYNCHROSEAL INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM AND SUCCESSFULLY PASSED BOTH RECOGNITION AND ENGAGEMENT TESTS. IT DEMONSTRATED INTUITIVE MOVEMENT WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS, AND THE BLADES OPERATED AS INTENDED. ENERGY DELIVERY TESTS WERE PERFORMED SUCCESSFULLY ACROSS VARIOUS GRIP ORIENTATIONS. BOTH SEAL AND CUT, AS WELL AS COAGULATION TESTS, WERE SUCCESSFUL. THE INSTRUMENT WAS FULLY FUNCTIONAL, WITH NO PRODUCT ISSUE FOUND." }, { "mdr_text_key": "391376424", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "389697765", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. A REVIEW OF THE ENERGY LOG SHOW THAT THE SYNCHROSEAL INSTRUMENT, THERE WERE 11 COAG AND 18 SEAL EVENTS, WITH NO ERRORS FOUND FOR EITHER FUNCTION. THERE WERE 196 TRANSECT EVENTS, SIX ¿HIGH INITIAL STARTING IMPEDANCE¿ ERRORS AND ONE ¿BLANK¿ ERROR WERE FOUND. THE LOGS SHOW ONE 'SYS ESTOP TRANSECT' AND ONE 'HIGH INITIAL STARTING IMPEDANCE' ERROR, INDICATING A POSSIBLE ISSUE WITH THE TRANSECT FUNCTION (POTENTIALLY DUE TO EXCESSIVE TISSUE BETWEEN JAWS). THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE. FIELD H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS." }, { "mdr_text_key": "389697766", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE OF SEGMENTS S4-5, AND S8, THE SYNCHROSEAL INSTRUMENT APPEARED TO DELIVER WEAKER THAN EXPECTED ENERGY, LEADING TO INSUFFICIENT TISSUE SEALING AFTER APPROXIMATELY 30 TO 45 MINUTES OF USE. NO ERROR MESSAGES WERE OBSERVED, AND IT IS UNCLEAR WHETHER THE APPROPRIATE AUDIBLE TONES WERE HEARD DURING SEALING OR UPON SEAL COMPLETION. ALTHOUGH THE CUTTING FUNCTION FUNCTIONED AS EXPECTED AND ENERGY DELIVERY APPEARED SUFFICIENT, THE TISSUE AND VESSEL SEALING REMAINED INADEQUATE. BLEEDING OCCURRED THROUGHOUT THE PROCEDURE BUT COULD NOT BE DEFINITIVELY ATTRIBUTED TO EITHER EXPECTED SURGICAL FACTORS OR INSUFFICIENT SEALING. THE VOLUME OF BLOOD LOSS WAS NOT PROVIDED; HOWEVER, THE BLEEDING WAS MANAGED USING A COMBINATION OF CAUTERY AND HEM-O-LOK CLIPS, WHICH ARE ROUTINELY UTILIZED IN SUCH PROCEDURES. TO RESOLVE THE ISSUE OF THE INSTRUMENT, A BACKUP SYNCHROSEAL INSTRUMENT WAS UTILIZED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS." } ], "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": "01/26/2026" } ] }