{ "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": "2955842-2026-04730", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260223", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260118", "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": "", "date_added": "20260223", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240426", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "484778", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260223", "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": [ "Use of Device Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/07/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260630", "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": "20260223", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "55 YR", "patient_sex": "Female", "patient_weight": "80 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Hernia", "Unspecified Gastrointestinal Problem" ] } ], "distributor_city": "", "date_report": "20260429", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24421829", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260126", "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": "393764854", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE. SIX DAYS AFTER SURGERY, A POSTOPERATIVE ILEUS, SECONDARY TO A TROCAR HERNIA, WAS IDENTIFIED WHICH REQUIRED SURGICAL INTERVENTION; IT WAS REPORTED AS RESOLVED THE NEXT DAY. THERE WAS NO ICU ADMISSION AND NO PROLONGED HOSPITALIZATION ATTRIBUTED TO THE EVENT. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), A CLAVIEN-DINDO GRADE III, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATE TO A THIRD-PARTY DEVICE, BUT PROBABLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, AND POSSIBLY RELATE TO THE DA VINCI INVESTIGATIONAL DEVICE." }, { "mdr_text_key": "393764855", "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." }, { "mdr_text_key": "401361327", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "401361328", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: FIFTEEN DAYS AFTER THE INDEX SURGICAL PROCEDURE, A SURGICAL SITE INFECTION WAS IDENTIFIED. THE INFECTION WAS REPORTED AN INFECTED SUBUMBILICAL TROCAR SEROMA. THE MEDICAL INTERVENTION REQUIRED AN OUTPATIENT SPLITTING OF THE SEROMA; NO MEDICATION (ANTIBIOTIC ADMINISTRATION) INTERVENTION WAS REPORTED. THE EVENT WAS REPORTED AS RESOLVED 10 DAYS LATER. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE I, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE. ADDITIONAL PATIENT DEMOGRAPHIC INFORMATION: BODY MASS INDEX (BMI): 28.7 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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/29/2026" } ] }