{ "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": "2955842-2025-29323", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250711", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250218", "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", "Literature", "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": "20250711", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "803533", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250711", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "N/A", "catalog_number": "N/A", "lot_number": "UNKNOWN", "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": "DC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250813", "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": "20250711", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20250616", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22479820", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250616", "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": "374798653", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE, \"ONE HUNDRED AND FIFTY-TWO ROBOTIC HEPATECTOMIES AT A NORTH AMERICAN HEPATOBILIARY PROGRAM: EVOLUTION OF PRACTICE, LEARNING CURVE, APPRAISAL OF OUTCOMES, AND COST ANALYSIS\" WAS PERFORMED. A RETROSPECTIVE ANALYSIS OF ALL HEPATECTOMIES (N=334) WAS PERFORMED AT AN INSTITUTION BETWEEN JANUARY 2018 TO JANUARY 2023. THIS INCLUDED 164 OPEN, 18 LAPAROSCOPIC, AND 152 ROBOTIC HEPATECTOMIES. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, THERE WAS 1 CASE IN THE ROBOTIC GROUP THAT WAS CONVERTED TO OPEN SURGERY DUE TO BLEEDING DURING A PARENCHYMAL TRANSECTION. THIS WAS A CONTROLLED CONVERSION WITH UPPER MIDLINE LAPAROTOMY AND THE PATIENT OTHERWISE RECOVERED UNEVENTFULLY AND WAS DISCHARGED HOME ON POST-OPERATIVE DAY 4. THERE WERE NO SPECIFIC DA VINCI MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTRA AND POST-OPERATIVE EVENT AND LENGTH OF STAY WERE SIGNIFICANTLY LOWER IN THE ROBOTIC GROUP. ROBOTIC HEPATECTOMY HAD SIGNIFICANTLY HIGHER TEXTBOOK OUTCOME AFTER LIVER SURGERY (TOLS) COMPARED TO OPEN HEPATECTOMY (85 PERCENT VERSUS 64 PERCENT, P LESS THAN 0.001)." }, { "mdr_text_key": "374798654", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: HAWKSWORTH, J., RADKANI, P., SHOUCAIR, S., GOGNA, S., FISHBEIN, T., & WINSLOW, E. (2025). ONE HUNDRED AND FIFTY-TWO ROBOTIC HEPATECTOMIES AT A NORTH AMERICAN HEPATOBILIARY PROGRAM: EVOLUTION OF PRACTICE, LEARNING CURVE, APPRAISAL OF OUTCOMES, AND COST ANALYSIS. SURGICAL ENDOSCOPY. HTTPS://DOI.ORG/10.1007/S00464-025-11570-2." } ], "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": "" } ] }