{ "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": "2955842-2024-17963", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240821", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240401", "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": "GM", "manufacturer_contact_area_code": "408", "date_added": "20240821", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2363287", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240821", "brand_name": "DA VINCI", "generic_name": "DA VINCI", "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": "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": "20250820", "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": "20240821", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Hemorrhage/Blood Loss/Bleeding", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "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": "20011521", "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": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "349684607", "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. THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION INCLUDING SYSTEM LOG REVIEW. CITATION: ROSA KLOTZ, ANDRÉ L. MIHALJEVIC, YAKUP KULU, ANJA SANDER, CHRISTINA KLOSE, ROUVEN BEHNISCH, MAXIMILIAN C. JOOS, EVA KALKUM, FELIX NICKEL, PHILLIP KNEBEL, FRANK PIANKA, MARKUS K. DIENER, MARKUS W. BÜCHLER, AND THILO HACKERT. \"ROBOTIC VERSUS OPEN PARTIAL PANCREATODUODENECTOMY (EUROPA): A RANDOMISED CONTROLLED STAGE 2B TRIAL\" KLOTZ, R., ET AL. 2024 HTTPS://DOI.ORG/10.1016/J.LANEPE.2024.100864. SECTION A2 REFLECTS PATIENT'S MEAN AGE IN ROBOTIC GROUP. SECTION A3 REFLECTS MAJORITY OF PATIENT'S GENDER IN ROBOTIC GROUP (MALE 17, FEMALE 12). SECTION B3 REFLECTS PUBLISHED DATE OF THE ARTICLE AS THE ACTUAL EVENT DATE IS NOT PROVIDED IN THE ARTICLE. SECTION D2 THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC DA VINCI MODEL; THEREFORE, SERIAL NUMBER AND UDI ARE UNKNOWN." }, { "mdr_text_key": "349684608", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW WAS CONDUCTED OF A LITERATURE ARTICLE COMPARING DA VINCI-ASSISTED ROBOTIC PARTIAL PANCREATODUODENECTOMY (RPD) WITH OPEN PARTIAL PANCREATODUODENECTOMY (OPD) SURGICAL PROCEDURES AT A HIGH-VOLUME PANCREATIC CENTER, HIGHLIGHTED FINDINGS OF A RANDOMISED CONTROLLED TRIAL (RCT) WITH TWO PARALLEL STUDY ARMS. THE STUDY INCLUDED 81 PATIENTS (41 ROBOTIC AND 40 OPEN) OVER A PERIOD OF APPROXIMATELY 1 1/2 YEARS AND COMPARED THE OUTCOMES OF THE RPD PATIENTS VERSUS THOSE OF THE OPD PATIENTS. DESCRIBED OUTCOMES INCLUDED POST-PANCREATECTOMY HEMORRHAGES (4 VERSUS 1), MAJOR BILIARY LEAKS (5 VERSUS 3), DELAYED GASTRIC EMPTYING (10 VERSUS 2), AND MAJOR CHYLE LEAKS (2 VERSUS 1). ALSO, IN THE RPD GROUP, 4 PATIENTS REQUIRED RE-OPERATION, 5 PATIENTS REQUIRED READMISSION, 15 PATIENTS REQUIRED NON-SURGICAL REINTERVENTION, 20 PATIENTS REQUIRED CT-GUIDED DRAIN PLACEMENT, 4 PATIENTS REQUIRED ANGIOGRAPHY, AND 7 PATIENTS REQUIRED UNSPECIFIED REINTERVENTION. BLOOD LOSS AND THE NUMBER OF PATIENTS WITH INTRAOPERATIVE BLOOD TRANSFUSIONS DID NOT DIFFER RELEVANTLY BETWEEN BOTH GROUPS. THE STUDY INDICATED THAT IN THE SETTING OF A VERY HIGH-VOLUME CENTER, BOTH RPD AND OPD CAN BE CONSIDERED SAFE TECHNIQUES. THERE WAS NO REPORT IN THE ARTICLE THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE PROCEDURES. THE DESIGNATED AUTHOR WAS CONTACTED AND STATED THEY CANNOT EXTERNALLY REPORT INDIVIDUAL OR DETAILED DATA FROM THE CRFS DUE TO DATA PROTECTION REGULATIONS IN THIS SETTING." } ], "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": "" } ] }