{ "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": "2955842-2026-16744", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260319", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240623", "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", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20260319", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "706310", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260319", "brand_name": "DA VINCI SURGICAL SYSTEMS", "generic_name": "DA VINCI", "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": "N/A", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260319", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Burn(s)" ] } ], "distributor_city": "", "date_report": "20260223", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24641517", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260223", "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": "396012167", "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. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE INCLUDED IN THE ARTICLE. A REVIEW OF THE SITE COMPLAINT HISTORY FOUND NO PRIOR COMPLAINTS RELATED TO THE ARTICLE EVENTS. CITATION: KUO, ET AL. (2024). EFFICACY OF DA VINCI ROBOTIC NIPPLE SPARING MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION WITH GEL IMPLANT IN BREAST CANCER. CHINESE JOURNAL OF MEDICAL AESTHETICS AND BEAUTY, 30(5), 425-429. DOI:10.3760/CMA.J.ISSN.1671-0290.2024.05.003." }, { "mdr_text_key": "396012168", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE CONCERNING A DA VINCI ROBOTIC NIPPLE SPARING MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION (RNSMIBR) WITH GEL IMPLANT WAS PERFORMED. THE AIM OF THE STUDY WAS TO ANALYZE THE EFFECT OF THE DA VINCI ROBOT IN NIPPLE-PRESERVING AREOLA-PRESERVING IMMEDIATE PROSTHETIC BREAST RECONSTRUCTION. SURGERIES WERE REVIEWED BETWEEN THE TIME PERIOD OF SEPTEMBER 2022 TO MAY 2024 USING THE DA VINCI SI AND XI SYSTEMS. A TOTAL OF 116 FEMALE PATIENTS WERE INCLUDED. A TOTAL OF 14 PATIENTS UNDERWENT SURGERY USING THE DA VINCI SI SURGICAL SYSTEM AND 102 PATIENTS UNDERWENT SURGERY USING THE DA VINCI XI SURGICAL SYSTEM. THE ARTICLE STATED THERE WERE \"TWO CASES OF IMPLANTS LOSS AND FIVE CASES OF HEAT STEAM-INDUCED SKIN DAMAGE.\" THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. IT WAS CONCLUDED THAT THE DA VINCI ROBOTIC NIPPLE-PRESERVING AREOLA IMMEDIATE PROSTHESIS BREAST RECONSTRUCTION SURGERY CAN PROVIDE GOOD COSMETIC RESULTS WITHOUT SERIOUS PERIOPERATIVE COMPLICATIONS. ALSO, RNSMIBR CAN PROVIDE BETTER OVERALL AESTHETIC RESULTS AND PATIENT SATISFACTION, AND MAY DECREASE THE RISK OF NIPPLE NECROSIS. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }