{ "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": "2955842-2025-45415", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251119", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251021", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20251119", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240513", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "819859", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251119", "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": "380601-50", "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", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/03/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260120", "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": "20251119", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "74 YR", "patient_sex": "Female", "patient_weight": "79 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Adhesion(s)", "Obstruction/Occlusion", "Adhesion(s)", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20251223", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23598111", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251023", "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": "390683266", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE PROCEDURE WAS A MALIGNANT HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY AND A SENTINEL LYMPH NODE BIOPSY SURGICAL PROCEDURE. THE BRIDENILEUS WAS REPORTED AS RESOLVED FOUR DAYS AFTER THE SURGICAL PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS PROBABLY RELATED TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE. THERE WAS NO RELEVANT MEDICATION OR HEALTH CONDITION THAT MAY BE RELEVANT TO THIS INCIDENT." }, { "mdr_text_key": "390683267", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "385602834", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BENIGN HYSTERECTOMY WITH SALPINGO-OOPHORECTOMY AND SENTINEL LYMPH NODE BIOPSY PROCEDURE. THE ORIGINAL PROCEDURE WAS COMPLETED WITHOUT PATIENT HARM, ADVERSE OUTCOMES, OR ANY DEVICE-RELATED MALFUNCTIONS INVOLVING THE DA VINCI SYSTEM, ITS INSTRUMENTS, OR ACCESSORIES. THE PATIENT WAS DISCHARGED HOME ON POST-OPERATIVE DAY THREE. THIRTY-FIVE DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH A DIAGNOSIS OF BRIDENILEUS, REQUIRING HOSPITAL ADMISSION AND SURGERY AS TREATMENT. THE EVENT WAS REPORTED AS RESOLVED ON AN UNSPECIFIED DATE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (SAE), A CLAVIEN-DINDO GRADE IIIB AND NOTE RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE." }, { "mdr_text_key": "385602835", "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 - 164 CM., BODY MASS INDEX (BMI) - 29.4 KG/M2." } ], "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": "12/23/2025" } ] }