{ "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": "2955842-2025-01838", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250220", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240628", "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": "RS", "manufacturer_contact_area_code": "408", "date_added": "20250220", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "457791", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250220", "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": "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": "20250220", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "63 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Renal Impairment", "Hemorrhage/Blood Loss/Bleeding", "Renal Impairment" ] } ], "distributor_city": "", "date_report": "20250128", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21426188", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250128", "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": "364078059", "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: MONAKOV DM, SAVIN LT, KOCHETOV AG, KARELSKAYA NA, DMITRIEVA TA, OGANYAN VA, MAGOMEDOV RN, GRITSKEVICH AA. ANALYSIS OF THE EXPERIENCE OF ROBOT ASSISTED CYSTECTOMY WITH VARIOUS TYPES OF URINE DERIVATION. UROLOGY REPORTS (ST. PETERSBURG). 2024;14(2):129¿138. DOI: HTTPS://DOI.ORG/10.17816/UROVED632838. SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. THE MEAN AGE OF THE PATIENTS WAS 63 YEARS, THE MAJORITY OF THE PATIENTS WERE MALES. (22 MEN AND 1 WOMAN) 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 MATERIAL NUMBER WAS USED." }, { "mdr_text_key": "364078060", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS OF 23 PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CYSTECTOMY WITH VARIOUS TYPES OF URINE DERIVATION OF BLADDER CANCER BETWEEN 2021 AND 2024. URINE DIVERSION BY UCS WAS PERFORMED IN 7 PATIENTS, AN ILEAL CONDUIT WAS FORMED USING THE BRICKER METHOD IN 6 PATIENTS, AND ORTHOTOPIC ILEOCYSTOPLASTY ACCORDING TO STUDER WAS PERFORMED IN 10 PATIENTS. IN THE EARLY POSTOPERA­TIVE PERIOD, COMPLICATIONS DEVELOPED IN 9 (39%) PATIENTS WITHIN 1¿16 DAYS AFTER SURGERY. IN MOST CASES, THIS WAS OBSTRUCTIVE PYELONEPHRITIS, WHICH REQUIRED PERCUTANEOUS PUNCTURE NEPHROSTOMY, WHICH CLASSIFIED AS CLAVIEN¿DINDO IIIA. NEPHROSTOMIES WERE CLOSED AFTER THE RESOLUTION OF PYELONEPHRITIS AND RESTORATION OF URINATION. IN ONE PATIENT WHO UNDERWENT CYSTOPROSTATECTOMY WITH EXTENDED PELVIC LYMPHADENECTOMY, LAPAROTOMY WAS PERFORMED ON POSTOPERATIVE DAY 2 DUE TO A DECREASE IN THE HEMOGLO­BIN LEVEL. DURING THE REVISION, DIFFUSE TISSUE HEMORRHAGE WAS DETECTED, WHICH WAS STOPPED USING HEMOSTATIC SPONGES. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT ISI PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED." } ], "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": "" } ] }