{ "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": "2955842-2025-25231", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250612", "manufacturer_address_2": "", "pma_pmn_number": "K191280", "date_of_event": "20250328", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20250612", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241017", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "510280", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250612", "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": "K10241017 0250", "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)261031(10)K10241017", "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", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/11/2025;09/23/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20251103", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20250612", "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", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250516", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22192927", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250516", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "383085092", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "383085093", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, H2, H3, H6, H11. THE SYNCHROSEAL INSTRUMENT WAS RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED PIVOT PIN. THE INSTRUMENT WAS FOUND TO HAVE A COMPLETELY MISSING THE JAW COVER. THE INSTRUMENT WAS ALSO FOUND TO HAVE A MISSING JAW COVER, MEASURING ROUGHLY 0.5120\" X 0.1945\" IN SIZE. THERE ARE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A MISSING JAW COVER WASHER. THE WASHER WAS NOT RETURNED WITH THE INSTRUMENT. FURTHERMORE, A VISUAL INSPECTION FOUND THE GRIP CABLE LOOSE FROM ITS ORIGINAL POSITION AT THE PROXIMAL END AND THE INSTRUMENT WAS RETURNED WITH THE POWER CORD CUT OFF. THERE WAS NO EVIDENCE OF ANY THERMAL DAMAGE OR SIGNS OF \"MELTING.\"" }, { "mdr_text_key": "372243997", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION." }, { "mdr_text_key": "372243998", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MEDIASTINAL MASS RESECTION, A SCREW ON THE SYNCHROSEAL INSTRUMENT'S WRIST PROTRUDED CAUSING TISSUE DAMAGE TO THE PULMONARY PARENCHYMA. THE BLEEDING WAS DESCRIBED AS A SMALL AMOUNT AND NOT MEASURED. NO BLOOD TRANSFUSIONS WERE GIVEN AND THE TISSUE WAS SUTURED TO ACHIEVE HEMOSTASIS. THE PROTRUDING SCREW DID NOT CAUSE ANY OTHER ISSUES WITH THE INSTRUMENT'S FUNCTION AND THE SURGEON IS NOT CONCERNED ABOUT ANY LONG-TERM COMPLICATIONS WITH THE PATIENT." }, { "mdr_text_key": "384087211", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "384087212", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H11. ADDITIONAL INFORMATION: THE INSTRUMENT LOGS WERE REVIEWED AND IT WAS NOTED THAT THE SYNCHROSEAL INSTRUMENT WAS USED FOR ABOUT AN HOUR. A TOTAL OF 11 COAG, 41 SEAL AND 125 TRANSECT EVENTS WITH 1 HIGH INITIAL STARTING IMPEDANCE ERROR WERE NOTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "09/05/2025;10/16/2025" } ] }