{ "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": "2955842-2025-08146", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250325", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250227", "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": "20250325", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20180928", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2660083", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250325", "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": "380601-33", "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": "MN", "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": "20250325", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "38 YR", "patient_sex": "Female", "patient_weight": "68 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250228", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21686706", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250228", "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": "366568309", "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. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE REMOTE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME." }, { "mdr_text_key": "366568310", "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) SURGICAL PROCEDURE AND WAS DISCHARGED THE SAME DAY. THE PATIENT EXPERIENCED POSTOPERATIVE SUBJECTIVE SWELLING OF THE LEFT BREAST AND SELF-REPORTED TO THE EMERGENCY DEPARTMENT ON POSTOPERATIVE DAY 0 OVERNIGHT. SHE WAS EVALUATED IN THE EMERGENCY DEPARTMENT AND THERE WERE NO SIGNS OR SYMPTOMS OF SWELLING, BLEEDING, INFECTION, WOUND ISSUES. SHE WAS DISCHARGED TO HOME ON THE SAME EVENING. SHE WAS SEEN IN FOLLOW-UP CLINIC THE NEXT DAY AND THE CONTRALATERAL (RIGHT) BREAST WAS NOTED TO HAVE BREAST SWELLING AND SIGNIFICANT CHANGE IN SIZE SINCE BEING SEEN IN THE EMERGENCY DEPARTMENT. ADDITIONALLY, THE RIGHT BREAST DRAIN HAD STOPPED DRAINING AND THE DRAIN OUTPUT WAS NOTED TO BE MORE SANGUINOUS IN NATURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND KEPT NOTHING BY MOUTH (NPO). INITIALLY, BREAST COMPRESSION WAS ATTEMPTED BUT HER DRAIN OUTPUT CONTINUED TO BE SANGUINOUS IN NATURE AND WAS ONGOING AND THEREFORE THE DECISION WAS MADE TO RETURN TO THE OPERATING ROOM FOR EVACUATION OF HEMATOMA. INTRAOPERATIVELY, THE TISSUE EXPANDER WAS REMOVED, THE BREAST POCKET WAS IRRIGATED, 30 CC OF CLOT WAS EVACUATED, THERE APPEARED TO BE MILD GENERALIZED OOZING ALONG THE MEDIAL ASPECT OF THE BREAST POCKET WHICH WAS CONTROLLED WITH VICRYL SUTURES. THERE WAS NO ACTIVE BLEEDING FROM THE DRAIN SITE. THE PECTORALIS MAJOR HAD GENERALIZED OOZING THAT WAS CONTROLLED WITH ELECTROCAUTERY AND VICRYL SUTURES. THE TISSUE EXPANDER WAS REPLACED, AND THE INCISION WAS CLOSED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED ON POSTOPERATIVE DAY ONE. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A CLAVIEN-DINDO GRADE III, WAS NOT RELATED TO A DA VINCI DEVICE OR SYSTEM, BUT POSSIBLY RELATED TO THE NSM PROCEDURE, AND POSSIBLY 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": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }