{ "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": "2955842-2025-08138", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250320", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20241011", "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", "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": "20250320", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2851832", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250320", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601", "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": "FL", "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": "20250320", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "64 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Sepsis", "Seroma", "Sepsis", "Seroma" ] } ], "distributor_city": "", "date_report": "20250225", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21651235", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250225", "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": "366217084", "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. A SYSTEM LOG REVIEW WAS NOT PERFORMED AS THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. CITATION: BAKER, H., GARRIGAN, A., WIEGAND, L. R., SINGLE-PORT ROBOTIC URETEROENTERIC STRICTURE REPAIR: A RETROSPECTIVE COHORT REVIEW CUREUS 16(10): E71262. DOI 10.7759/CUREUS.71262. 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 SP SYSTEM WAS REPORTED." }, { "mdr_text_key": "366217085", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE COHORT REVIEW OF 16 PATIENTS FROM A SINGLE SURGEON UNDERGOING SINGLE-PORT ROBOTIC REVISION OF URETEROENTERIC STRICTURE (UES) FOLLOWING RADICAL CYSTECTOMY WITH URINARY DIVERSION FROM SEPTEMBER 2020 THROUGH JULY 2024. THE OBJECTIVE OF THIS STUDY IS TO PRESENT A SERIES OF CASES UTILIZING SINGLE-PORT ROBOT-ASSISTED REPAIR FOR (UES) TO DEMONSTRATE THE PROCEDURE'S SAFETY AND FEASIBILITY. THE ARTICLE DESCRIBED A PATIENT WHO HAD AN ILEAL CONDUIT WITH A STRICTURE OF 1 CM IN LENGTH ON THE RIGHT. THE TYPE OF STRICTURE REPAIR THAT THE PATIENT HAD WAS HEINEKE-MIKULICZ (HM) TISSUE REARRANGEMENT. THE PATIENT EXPERIENCED UROSEPSIS AND SEROMA THAT EVOLVED INTO SUPERFICIAL WOUND SEPARATION, WHICH WAS TREATED WITH WOUND PACKING AND HEALED BY SECONDARY INTENTION. THE ARTICLE MENTIONED ANOTHER SEROMA, AND INCISIONAL HERNIA THAT DID NOT REQUIRE OPERATIVE INTERVENTION AND WERE TREATED CONSERVATIVELY. TWO OTHER CASES REQUIRED CONVERSION TO OPEN DUE TO ANATOMY (ADHESIONS). THE STUDY INVESTIGATOR RESPONDED TO FOLLOW-UP AND REPORTED THAT THERE WERE NO DA VINCI DEVICE MALFUNCTIONS, THAT THE ROBOT WAS NOT THE CAUSE OF THE OF THE COMPLICATIONS AND THAT PATIENT DEMOGRAPHICS AND INFORMATION REGARDING PROCEDURE DATE, SYSTEM SERIAL NUMBER AND SURGEON'S NAME ARE NOT AVAILABLE." } ], "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": "" } ] }