{ "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": "2955842-2025-17386", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250506", "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": "20250506", "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": "714166", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250506", "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": "380601", "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": "20250826", "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": "20250506", "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": [ "Necrosis", "Full thickness (Third Degree) Burn", "Necrosis", "Full thickness (Third Degree) Burn" ] } ], "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": "21972079", "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": "369698017", "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": "369698018", "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 (NSM) PROCEDURE. DURING THE PROCEDURE, A BURN AREA ON THE LEFT BREAST WAS IDENTIFIED, SUPERIOR TO THE NIPPLE-AREOLA COMPLEX (NAC). THE AREA WAS THROUGH AND THROUGH, WITH DISCHARGE OF FLUID FROM WITHIN THE BREAST POCKET AND WAS EXCISED DUE TO SKIN NECROSIS IN ELLIPTICAL FULL THICKNESS THROUGH TO THE BREAST POCKET. THE LENGTH OF THE WOUND WAS 2 CM. IT WAS THEN REPAIRED WITH A 3-0 MONOCRYL SUTURE AND IN DEEP DERMAL INTERRUPTED FASHION, AND RUNNING SUBCUTICULAR FASHION. IT WAS THEN COVERED WITH SILVADENE CREAM. THE PATIENT WAS DISCHARGED THE SAME DAY AND THE EVENT HAS BEEN REPORTED AS RESOLVED AND THE PATIENT 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/NECROSIS 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": "" } ] }