{ "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": "2955842-2024-22757", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241209", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240702", "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": "BR", "manufacturer_contact_area_code": "408", "date_added": "20241209", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "337545", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241209", "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": "UNKNOWN", "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": "20250822", "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": "20241209", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "62 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection", "Fistula", "Hemorrhage/Blood Loss/Bleeding", "Post Operative Wound Infection" ] } ], "distributor_city": "", "date_report": "20241114", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20877965", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241114", "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": "358614619", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE THAT DESCRIBED AN OBSERVATIONAL STUDY TO EVALUATE THE OUTCOMES OF EVALUATE THE OUTCOMES OF 150 PATIENTS THAT UNDERWENT ROBOTIC PANCREATODUODENECTOMY (RPD) IN A SINGLE-CENTER SETTING, ANALYZING THE PROGRESSION OF THE PROCEDURE¿S COMPLEXITY AND COMPLICATION RATES ACROSS DIFFERENT PHASES OF THE SURGEON'S LEARNING CURVE FROM MARCH 2018 TO APRIL 2023. THE MEAN TOTAL OPERATIVE TIME WAS 402.4 MINUTES WITH A MEDIAN HOSPITAL STAY OF 7 DAYS. THE ARTICLE NOTED SEVERAL ADVERSE EVENTS DURING THESE SURGERIES. 5 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY. BLOOD TRANSFUSIONS WERE GIVEN FOR 10 PATIENTS DURING HOSPITALIZATION. BIOCHEMICAL LEAKAGE WAS OBSERVED IN 42 PATIENTS, AND OVERALL COMPLICATIONS WERE REPORTED IN 30 PATIENTS. THIRTEEN PATIENTS EXPERIENCED COMPLICATIONS OF SEVERITY LEVEL IIIA OR HIGHER BASED ON THE CLAVIEN-DINDO CLASSIFICATION, WHICH INCLUDED EIGHT PATIENTS EXPERIENCED GRADE B POSTOPERATIVE PANCREATIC FISTULA (POPF) AND TWO PATIENTS WITH GRADE C POPF. ONE PATIENT EXPERIENCED WOUND INFECTIONS, AND HEMORRHAGIC COMPLICATIONS OCCURRED IN FIVE PATIENTS: TWO PATIENTS WITH BLEEDING FROM A DUODENOJEJUNOSTOMY SUCCESSFULLY CONTROLLED VIA UPPER ENDOSCOPY AND THREE PATIENTS WITH PSEUDOANEURYSMS OF THE GASTRODUODENAL ARTERY TREATED VIA INTERVENTIONAL RADIOLOGY. DELAYED GASTRIC EMPTYING OCCURRED FOR THREE PATIENTS: ONE GRADE B PATIENT AND TWO GRADE C PATIENTS. THESE PATIENTS HAD PROLONGED HOSPITAL STAYS (18, 34, AND 71 DAYS, RESPECTIVELY). THE GRADE B PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY (POD) 18. ONE PATIENT REQUIRED REOPERATION FOR GASTRIC TORSION, WITH THE STOMACH FIXED IN THE ABDOMINAL WALL, AND WAS DISCHARGED ON POD71. THE STUDY CONCLUDED THAT ROBOTIC PANCREATODUODENECTOMY IS A SAFE AND FEASIBLE APPROACH IN SPECIALIZED CENTERS, WITH EXPERIENCE LEADING TO REDUCED OPERATIVE TIMES, FEWER COMPLICATIONS, AND ENHANCED OUTCOMES. THERE WAS NO MENTION OF ANY DA VINCI DEVICE ISSUES IN THE ARTICLE. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "358614620", "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. CITATION: MACHADO, M.A.C., MATTOS, B.V., LOBO FILHO, M.M. ET AL. ROBOTIC PANCREATODUODENECTOMY: INCREASING COMPLEXITY AND DECREASING COMPLICATIONS WITH EXPERIENCE: SINGLE-CENTER RESULTS FROM 150 CONSECUTIVE PATIENTS. ANN SURG ONCOL 31, 7012¿7022 (2024). HTTPS://DOI.ORG/10.1245/S10434-024-15645-7. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEDIAN AGE OF THE ROBOTIC GROUP WAS 62 YEARS, MAJORITY OF THE PATIENTS WERE MALE (82 MAN AND 68 WOMEN) FIELD B3: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM WAS USED." } ], "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": "" } ] }