{ "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": "2955842-2025-11757", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250409", "manufacturer_address_2": "", "pma_pmn_number": "K171294", "date_of_event": "20250111", "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": "20250409", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "370792", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250409", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "PATIENT SIDE CART, 4-ARM", "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": "380620", "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": "20250825", "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": "20250409", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Embolism/Embolus", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Infection", "Embolism/Embolus" ] } ], "distributor_city": "", "date_report": "20250313", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21810176", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250313", "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": "367852674", "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. FARZAT ET AL. ROBOTIC SURGERY OF THE UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT SINGLE SURGEON INITIAL EXPERIENCE, 66 CONSECUTIVE CASES. BMC UROLOGY (2024) 24:238 HTTPS://DOI.ORG/10.1186/S12894-024-01629-Y. IN SECTION B3, THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, A GENERIC XI SYSTEM WAS REPORTED." }, { "mdr_text_key": "367852675", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE \"ROBOTIC SURGERY OF THE UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT SINGLE SURGEON INITIAL EXPERIENCE, 66 CONSECUTIVE CASES\" WAS PERFORMED. THE STUDY INVESTIGATED THE ADVANTAGES AND BURDEN OF ROBOT-ASSISTED SURGICAL TREATMENT OF THE UROTHELIAL CARCINOMA OF THE UPPER URINARY TRACT. THE STUDY INCLUDED 66 PROSPECTIVELY ENROLLED PATIENTS WHO WERE SURGICALLY TREATED BY A SINGLE, ROBOTICALLY SPECIALIZED SURGEON BETWEEN JULY 2019 AND DECEMBER 2023. THE PATIENTS¿ MEAN AGE WAS 71 YEARS. THE PATIENTS WERE DIVIDED INTO THREE GROUPS. GROUP 1: 50 PATIENTS UNDERWENT ROBOT-ASSISTED RADICAL NEPHROURETERECTOMY (RANU) WITH BLADDER CUFF EXCISION, GROUP 2: 11 PATIENTS UNDERWENT RANU SIMULTANEOUSLY WITH ROBOT-ASSISTED RADICAL CYSTECTOMY (RARC), AND GROUP 3: 5 PATIENTS UNDERWENT ROBOT-ASSISTED SEGMENTAL URETERECTOMY (RASU). COMPLICATIONS OBSERVED INCLUDED 4 INCISIONAL HERNIAS ON THE MINI-LAPAROTOMY SITE THAT WAS USED TO EXTRACT THE SPECIMEN, EMBOLUS, HEMORRHAGE, SURGERY, AND WOUND INFECTION. ONE FEMALE PATIENT DEVELOPED AN EMBOLUS OF THE ARTERIA ILIACA EXTERNA AND HAD TO UNDERGO AN EMERGENCY EMBOLECTOMY. ONE (B)(6)-YEAR-OLD MALE PATIENT EXPERIENCED BLEEDING ON THE FIRST OPERATIVE DAY WITH A HEMOGLOBIN DECREASE OF MORE THAN 6 G/DL AFTER AN UNEVENTFUL INTRAOPERATIVE COURSE. ONE MALE PATIENT HAD A DIAGNOSTIC LAPAROSCOPY DUE TO SUSPICION OF MECHANICAL BOWEL OBSTRUCTION, WHICH WAS NOT CONFIRMED, AND RESOLVED AFTER FURTHER MEDICAL BOWEL STIMULATION. THE FINAL COMPLICATION WAS A WOUND INFECTION WHICH NECESSITATED A WOUND REVISION AND A SUPERFICIAL VACUUM-ASSISTED CLOSURE SYSTEM. THE ARTICLE NOTED THAT DURING THESE DA VINCI SURGERIES, ADVERSE EVENTS WERE REPORTED IN FOUR PATIENTS POST-OPERATIVELY. SIX PATIENTS RECEIVED BLOOD TRANSFUSION, AND THE OVERALL COMPLICATION RATE WAS 24%. THE READMISSION RATE WAS 7.5%. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT." } ], "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": "" } ] }