{ "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": "2955842-2025-46236", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251126", "manufacturer_address_2": "", "pma_pmn_number": "K133167", "date_of_event": "20251030", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20251126", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2237756", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251126", "brand_name": "DA VINCI", "generic_name": "MONOPOLAR CAUTERY CORD", "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": "470383-06", "catalog_number": "470383", "lot_number": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GEI", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Electrosurgical, Cutting & Coagulation & Accessories", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4400", "device_class": "2" } } ], "product_problems": [ "Thermal Decomposition of Device", "Thermal Decomposition of Device" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251201", "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": "20251126", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20251126", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23659579", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251030", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "386171005", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) PERFORMED A FIELD EVALUATION AT THE SITE AND IDENTIFIED THAT A MONOPOLAR PORT ON THE ERBE GENERATOR WAS NOT FUNCTIONAL. AS A RESULT, THE FSE REPLACED THE ERBE GENERATOR. THE ERBE GENERATOR WAS RECEIVED FOR FAILURE ANALYSIS INVESTIGATIONS. THE ERBE WAS TESTED ON A SYSTEM AND MONOPOLAR SLOT 1 COULD NOT RECOGNIZE/DETECT THE INSTRUMENT. THE CUSTOMER WAS ADVISED TO RETURN THE MONOPOLAR ENERGY CABLE, BUT IT HAS NOT BEEN RECEIVED. THE SYSTEM LOGS FOR THIS PROCEDURE WERE REVIEWED AND FOUND NO RELATED ERRORS. A REVIEW OF IMAGES PROVIDED BY THE CUSTOMER IS CONSISTENT WITH THE REPORTED COMPLAINT: THE MONOPOLAR ENERGY CABLE AND SURGEON'S GOWN WERE OBSERVED TO BE BURNED. THE ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE." }, { "mdr_text_key": "386171006", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE MONOPOLAR ENERGY CABLE BURNED THROUGH THE SURGEON¿S GOWN. AS A RESULT, THE SURGEON'S ARM WAS ALSO REPORTEDLY BURNED WHILE AT THE BEDSIDE. THE CABLE WAS REPLACED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY TO THE PATIENT. THE SURGEON REPORTEDLY TREATED THE BURN INJURY WITH BURN CREAM/OINTMENT." } ], "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": "" } ] }