{ "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": "2955842-2025-17364", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250502", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250407", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250502", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190904", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1678799", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250502", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601-34", "catalog_number": "N/A", "lot_number": "N/A", "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": "00886874114605", "udi_public": "(01)00886874114605", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "Y", "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": "20250502", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "56 YR", "patient_sex": "Female", "patient_weight": "58 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Black Or African American", "patient_problems": [ "Burn(s)", "Burn(s)" ] } ], "distributor_city": "", "date_report": "20250407", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21949313", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250407", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "369406097", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "369406098", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT WHO WAS ENROLLED IN A STUDY, UNDERWENT A DA VINCI ASSISTED NIPPLE SPARING MASTECTOMY SURGICAL PROCEDURE. DURING THE PROCEDURE AN AREA OF SKIN BURN INJURY/BLISTERING TO THE LEFT MASTECTOMY FLAP WERE NOTED WITHIN THE NAC INVOLVING MOST OF THE AREOLA INFERIOR TO THE PAPULE FROM 4:00 TO 7:00. THE AREA DID NOT BLANCH. NITRO PASTE WAS PLACED OVER THE NIPPLE-AREOLAR COMPLEX AND SEALED WITH TEGADERM. THE PATIENT WAS DISCHARGED OTHER SAME DAY AND WILL RETURN IN A FEW WEEKS FOR A RE-EVALUATION AND PROCEED WITH RECONSTRUCTION. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. THE STUDY INVESTIGATOR INDICATED THAT THERE WERE NO INTRAOPERATIVE DEVICE MALFUNCTIONS AND THE INJURY WAS OBSERVED AFTER DOCKING OF THE SYSTEM. THE EVENT WAS REPORTED AS SEVERE, POSSIBLY RELATED TO THE DA VINCI SYSTEM, POSSIBLY RELATED TO THE NSM PROCEDURE, BUT NOT RELATED TO RECONSTRUCTION, AND NOT RELATED TO THE PATIENT'S PRE-EXISTING CONDITION. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP. THE STUDY INVESTIGATOR STATED THERE WAS NO ARCING OR SPARKING COMING FROM ANY OF THE INSTRUMENTS AND THE CAUSE OF THE BURN INJURY WAS THAT THE FLAP WAS TOO THIN." } ], "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": "" } ] }