{ "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": "2955842-2024-23231", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241217", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240515", "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", "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20241217", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220907", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "292491", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241217", "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": "380601-45", "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": "", "udi_public": "", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241217", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "45 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Hematoma", "Necrosis", "Bacterial Infection", "Hematoma", "Necrosis" ] } ], "distributor_city": "", "date_report": "20241120", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20950935", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241120", "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": "359342779", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT TUMESCENT-FREE ROBOTIC NIPPLE SPARING MASTECTOMY (NSM) BETWEEN OCTOBER 2020 AND MARCH 2023 AT ONE SINGLE INSTITUTION. THE ARTICLE NOTED THAT AMONG 118 PATIENTS, THAT UNDERWENT ROBOTIC NSM, THIRTY-ONE PATIENTS EXPERIENCED AN ADVERSE EVENT, WITH 8 PATIENTS EXPERIENCING GRADE II OR HIGHER ADVERSE EVENTS, WHICH REQUIRED MORE THAN THE USUAL SYMPTOMATIC CARE. TWO PATIENTS HAD A HEMATOMA AT THE BREAST SURGERY SITE; ONE OF THESE PATIENTS RECEIVED BLEEDING CONTROL IN THE OPERATING ROOM UNDER GENERAL ANESTHESIA, AND THE OTHER PATIENT IMPROVED AFTER A BLOOD TRANSFUSION. TWO PATIENTS HAD NIPPLE-AREOLAR COMPLEX (NAC) NECROSIS, AND BOTH HAD TO UNDERGO NAC REMOVAL. ONE PATIENT HAD SKIN NECROSIS AND UNDERWENT DEBRIDEMENT UNDER LOCAL ANESTHESIA IN THE OPERATING ROOM. TWO PATIENTS EXPERIENCED INFECTION; 1 WAS LOCATED IN THE NAC AND THE OTHER IN THE AXILLA, BOTH OF WHICH IMPROVED AFTER ANTIBIOTIC TREATMENT. THERE WAS NO DA VINCI DEVICE MALFUNCTION MENTIONED IN THE ARTICLE. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION OCCURRED IN ANY OF THE PROCEDURES, AND THE COMPLICATIONS WERE NOT CAUSED OR CONTRIBUTED BY ANY OF THE DA VINCI PRODUCTS." }, { "mdr_text_key": "359342780", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATION: HWANG YH, HAN HH, EOM JS, YOO TR, KIM J, CHUNG IY, KO B, KIM HJ, LEE JW, SON BH, LEE SB. EVALUATION OF SAFETY AND OPERATIVE TIME IN TUMESCENT-FREE ROBOTIC NIPPLE-SPARING MASTECTOMY: A RETROSPECTIVE SINGLE-CENTER COHORT STUDY. ANN SURG TREAT RES. 2024 JUL;107(1):8-15. HTTPS://DOI.ORG/10.4174/ASTR.2024.107.1.8. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEAN AGE OF THE PATIENTS WAS 45 YEARS, AND PATIENTS WERE FEMALE ACCORDING TO THE TYPE OF PROCEDURE. FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, ACCEPTANCE DATE FOR PUBLISH HAS BEEN USED." } ], "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": "" } ] }