{ "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": "2955842-2026-00085", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260108", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251023", "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": "", "date_added": "20260109", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220627", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "77982", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260108", "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": "380601", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/16/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260518", "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": "20260108", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "45 YR", "patient_sex": "Female", "patient_weight": "59 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Bacterial Infection", "Seroma" ] } ], "distributor_city": "", "date_report": "20260501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24016570", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251215", "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": "401575739", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: APPROXIMATELY SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT REPORTED RIGHT BREAST REDNESS AND WARMTH; ANTIBIOTICS WERE STARTED. THE EVENT WAS REPORTED AS SKIN FLAP ERYTHEMA (RIGHT). AN EXAMINATION BY PLASTIC SURGERY WAS PERFORMED THE NEXT DAY; A FLUID COLLECTION AND OVERLYING PATCHY ERYTHEMA WAS NOTED. OUTPATIENT SURGERY WAS SCHEDULED AND THE PATIENT UNDERWENT WASHOUT, ANTIBIOTIC BEAD PLACEMENT, AND IMPLANT EXCHANGE TWO DAYS LATER, AT WHICH TIME THE EVENT WAS REPORTED AS RESOLVED. CULTURE SAMPLES TAKEN DURING THE WASHOUT AND IMPLANT EXCHANGE WERE RETURNED AS NEGATIVE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NOT RELATED TO THE DA VINCI STUDY DEVICE, NOT RELATED TO THE ROBOTIC NIPPLE SPARING MASTECTOMY PROCEDURE, BUT PROBABLY RELATED TO THE RECONSTRUCTION PROCEDURE." }, { "mdr_text_key": "401575740", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "389704047", "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. ADDITIONAL PATIENT INFORMATION: HEIGHT 166.5 CM." }, { "mdr_text_key": "389704048", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BILATERAL NIPPLE SPARING MASTECTOMY (NSM) PROCEDURE. FORTY-SEVEN DAYS AFTER THE INDEX PROCEDURE, PLASTIC SURGERY NOTED MILD BILATERAL HYPEREMIA. THE FOLLOWING DAY, THE PATIENT REPORTED WORSENING LEFT BREAST REDNESS, WARMTH, AND SORENESS, POSSIBLY RELATED TO HEAVIER PHYSICAL ACTIVITY, SO ORAL ANTIBIOTICS WERE STARTED. DUE TO LACK OF IMPROVEMENT, SHE WAS RE-EXAMINED FOUR DAYS LATER AND UNDERWENT LEFT BREAST WASHOUT WITH PLACEMENT OF ABSORBABLE ANTIBIOTIC BEADS AND IMPLANT EXCHANGE. A SMALL SEROMA WAS NOTED INTRAOPERATIVELY; TWO CULTURES WERE OBTAINED AND WERE NEGATIVE. THE EVENT WAS REPORTED AS RESOLVED THE SAME DAY. THE BILATERAL SKIN FLAPS WERE VIABLE AT THE END OF THE INDEX NSM AND RECONSTRUCTION PROCEDURES. ONE STAGE RECONSTRUCTION WAS PERFORMED. A LEFT BREAST INCISION WAS EXTENDED DURING RECONSTRUCTION. THERE WERE BILATERAL DRAIN PLACEMENTS WHICH WERE REMOVED EIGHT DAYS AFTER THE INDEX PROCEDURE. THERE WERE NO INTRA-OPERATIVE ADVERSE EVENTS AND NO DA VINCI DEVICE MALFUNCTIONS DURING THE PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, A CLAVIEN-DINDO GRADE III, A SERIOUS ADVERSE EVENT (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT), NOT RELATED TO THE DA VINCI STUDY DEVICE, NOT RELATED TO THE NSM PROCEDURE, BUT PROBABLY RELATED TO THE RECONSTRUCTION PROCEDURE." } ], "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": "05/01/2026" } ] }