{ "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": "2955842-2024-17943", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240815", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240411", "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": "DA", "manufacturer_contact_area_code": "408", "date_added": "20240815", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1164502", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240815", "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": "20250821", "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": "20240815", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "67 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Failure to Anastomose", "Hemorrhage/Blood Loss/Bleeding", "Failure to Anastomose", "Hemorrhage/Blood Loss/Bleeding" ] } ], "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": "19992745", "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": "349432690", "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 SINCE THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE. SOURCE: ALEXANDER B. NOLSØE, PETER BUSCH ØSTERGREN1, HENRIK JAKOBSEN, CHRISTIAN FUGLESANG S. JENSEN, NIELS HENRIK BRUUN, JENS SØNKSEN AND MIKKEL FODE. \"CAN NERVE MONITORING DURING RADICAL PROSTATECTOMY IMPROVE FUNCTIONAL OUTCOMES? A RANDOMISED TRIAL\" NOLSØE, A., ET AL. 2024 BJU INT 2024 DOI:10.1111/BJU.16295 FIELD A2 REFLECTS PATIENT'S MEAN AGE IN ROBOTIC GROUP. FIELD B3 REFLECTS PUBLISHED DATE OF THE ARTICLE AS THE ACTUAL EVENT DATE IS NOT PROVIDED IN THE ARTICLE." }, { "mdr_text_key": "349432691", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE THAT ADDRESSES THE POSSIBLE BENEFITS OF NERVE MONITORING DURING DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURES, THE FOLLOWING COMPLICATIONS WERE MENTIONED: THE STUDY WITH 100 PATIENTS ENROLLED, EXAMINED THE BENEFITS OF USING A NERVE MONITORING SYSTEM DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY (THE INTERVENTION ARM) VERSUS THE STANDARD OF CARE (THE CONTROL GROUP). AVAILABLE FOR FINAL ANALYSIS AT 12 MONTHS 82 PATIENTS REMAINED IN THE STUDY, 41 PATIENTS IN EACH GROUP. THERE WERE EIGHT CLAVIEN-DINDO GRADE GREATER THAN OR EQUAL TO III COMPLICATIONS, ONE CASE OF SEVERE MESENTERIC BLEEDING, ONE RECTAL LESION, AND ONE SPHINCTERIC LESION, ALL IN THE CONTROL GROUP. THERE WERE FIVE CASES OF ANASTOMOSIS LEAKAGE, TWO IN THE INTERVENTION GROUP AND THREE IN THE CONTROL GROUP. WE DETECTED NERVE SIGNALS DURING MONITORING IN ALL PARTICIPANTS IN THE INTERVENTION GROUP BEFORE THE REMOVAL OF THE PROSTATE. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN SURGICAL TIME OR BLOOD LOSS. THERE WAS NO REPORT IN THE ARTICLE THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE PROCEDURES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }