{ "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": "2955842-2024-18003", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240813", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240202", "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", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20240813", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1176445", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240813", "brand_name": "DA VINCI XI", "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": "380652", "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", "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": "20250821", "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": "20240813", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "60 YR", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pleural Effusion", "Liver Failure", "Hemorrhage/Blood Loss/Bleeding", "Pleural Effusion", "Liver Failure" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19977379", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "349196078", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS MEDWATCH REPORT REFLECTS ADVERSE EVENT ONLY DATA FROM A LITERATURE ARTICLE. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. THE DESIGNATE AUTHOR WAS CONTACTED FOR ADDITIONAL INFORMATION AND THE ONLY STATEMENT RECEIVED WAS THAT THE DOCUMENTED COMPLICATION RATES WERE WITHIN THE EXPECTED RANGE. CITATION: \"RESULTS OF ROBOTIC LIVER SURGERY IN ASSOCIATION WITH IWATE CRITERIA ¿ THE FIRST 100 CASES.\" (STEINKRAUS KC, TRAUB B, HEGER P, HUTTNER FJ, ET AL. 2024); LANGENBECK¿S ARCHIVES OF SURGERY, (2024) 409:50. HTTPS://DOI.ORG/10.1007/S00423-024-03239-6. SECTION A THE PATIENT MEDIAN AGE WAS 65 YEARS AND MEDIAN BMI WAS 25.9 YEARS. AMONG THEM, 41% WERE FEMALE AND 59% WERE MALE. 2 AGE REPRESENTS THE MEDIAN AGE IN YEARS." }, { "mdr_text_key": "349196079", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) REVIEWED A JOURNAL ARTICLE THAT DESCRIBES A PROSPECTIVE SINGLE-CENTER COHORT STUDY THAT WAS PERFORMED. THE AIM OF THE STUDY WAS TO REVIEW THE FIRST 100 PATIENTS IN THE IMPLEMENTATION PHASE OF A NEW DA VINCI ROBOTIC LIVER SURGERY PROGRAM IN THEIR INSTITUTION TO ASSESS THE USE OF THE IWATE DIFFICULTY SCORES IN PREDICTING SURGICAL DIFFICULTY AND POSTOPERATIVE COMPLICATIONS. THE CONCLUSION OF THE STUDY FOUND THAT THE IWATE CATEGORIES HAD THE ABILITY TO PREDICT BOTH THE DIFFICULTY OF SURGERY AS WELL AS POSTOPERATIVE OUTCOMES WHEN ASSESSING THE COMPLEXITY OF ROBOTIC LIVER SURGERY, WHICH MAY AID IN APPROPRIATE PATIENT SELECTION. THE STUDY OCCURRED FROM NOVEMBER 2020 TO JANUARY 2023. THE ARTICLE NOTED THAT MAJOR LIVER RESECTIONS WERE PERFORMED IN 17% OF CASES, WHILE ATYPICAL RESECTIONS WERE THE MOST COMMON AT 49%, WITH THE REMAINING BEING ANATOMICAL SEGMENTECTOMIES (17%) AND LEFT LATERAL SECTIONECTOMIES (13%). THE MEDIAN BLOOD LOSS WAS 300 ML, AND 22 (22%) PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSIONS. CONVERSION TO OPEN SURGERY OCCURRED IN 6% OF CASES DUE TO INTRAOPERATIVE BLEEDING TENDENCY (3 CASES), VASCULAR INFILTRATION (2 CASES), AND ADHESIONS (1 CASE). SIGNIFICANT POSTOPERATIVE OUTCOMES WERE REPORTED TO INCLUDE PLEURAL EFFUSION IN 5% OF PATIENTS AND BILE LEAKAGE IN 4%. POST-HEPATECTOMY LIVER FAILURE OCCURRED IN 7% OF CASES. REINTERVENTION FOR PERCUTANEOUS DRAINAGE, PLEUROCENTESIS, AND UNSPECIFIED ENDOSCOPIC INTERVENTIONS WERE NECESSARY FOR 10% OF PATIENTS, UNSPECIFIED REOPERATION FOR 3%, AND UNSPECIFIED REHOSPITALIZATION FOR 11%. THE ARTICLE DOCUMENTED SEVERAL LIMITATIONS TO THIS STUDY. FIRST, IT WAS A COHORT STUDY CONDUCTED AT A SINGLE CENTER, LIMITING THE GENERALIZABILITY OF THE RESULTS TO OTHER SITES. SECOND, AS A RETROSPECTIVE ANALYSIS, IT CARRIES INHERENT RISKS OF BIAS, THOUGH THE DATA QUALITY AND COMPLETENESS OF FOLLOW-UP WERE HIGH DUE TO THE PROSPECTIVE DATABASE USED. THIRD, THE SAMPLE SIZE IS LIMITED, AND A LEARNING CURVE EFFECT MAY HAVE OCCURRED BUT WAS NOT SPECIFICALLY EVALUATED. THE DESIGNATED AUTHOR WAS CONTACTED AND CONFIRMED THAT THE COMPLICATION RATES WERE WITHIN THE EXPECTED RANGE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO DA VINCI DEVICE ISSUES WERE REPORTED IN THE ARTICLE." } ], "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": "" } ] }