{ "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": "2955842-2024-21927", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241120", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20231114", "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": "20241120", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2433081", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241120", "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": "380601-34", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20241120", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Air Embolism", "Air Embolism" ] } ], "distributor_city": "", "date_report": "20241029", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20735391", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241029", "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": "357141361", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING THE REVIEW OF A LITERATURE ARTICLE WHICH DESCRIBED A RETROSPECTIVE COHORT STUDY, A SINGLE-PORT TRANSVESICAL (TV) ROBOT-ASSISTED SIMPLE PROSTATECTOMY (RASP) WAS PERFORMED. THE ARTICLE NOTED THAT DURING THESE SURGERIES, THERE WERE TWO SUSPECTED VENOUS AIR EMBOLI IN THE COHORT. THE AUTHORS ATTRIBUTED THIS EFFECT TO PNEUMOVESICUM PRESSURES (>12 MMHG). ONE OF THE PATIENTS HAD A SPONTANEOUS RESOLUTION IN THE OPERATING ROOM WITH HIGH-FLOW OXYGEN AND REPOSITIONING TO LEFT LATERAL DECUBITUS. THE SECOND PATIENT REQUIRED MANAGEMENT IN THE INTENSIVE CARE UNIT FOR 3 DAYS; HE WAS ALSO THE ONLY PATIENT THAT REQUIRED CONTINUOUS BLADDER IRRIGATION (CBI) POST OPERATIVELY. THE AUTHORS ALSO NOTED THAT PNEUMOVESICUM PRESSURE WAS SET AT 10 MMHG USING AN AIRSEAL (CONMED, UTICA, NY, USA) SYSTEM. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. 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." }, { "mdr_text_key": "357141362", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO SPECIFIC INFORMATION REGARDING THE PROCEDURE SITE OR DATE WAS PROVIDED; THEREFORE, NO DA VINCI SYSTEM OR ACCESSORIES LOG FILES ARE AVAILABLE. THE STUDY OCCURRED FROM FEBRUARY 2019 TO AUGUST 2023, WHERE 117 PATIENTS UNDERWENT SINGLE-PORT TV ROBOT-ASSISTED SIMPLE PROSTATECTOMY (RASP), WITH A MEAN AGE OF 68.8 YEARS AND A MEAN BMI OF 28.8. THE GENDER DISTRIBUTION WAS 100% MALE. ROXANA RAMOS, ETHAN FERGUSON, MAHMOUD ABOU ZEINAB, NICOLAS SOPUTRO, JAYA S. CHAVALI, ADRIANA M. PEDRAZA, ZEYAD SCHWEN, CARTER MIKESELL, JIHAD KAOUK, SINGLE-PORT TRANSVESICAL ROBOT-ASSISTED SIMPLE PROSTATECTOMY: SURGICAL TECHNIQUE AND CLINICAL OUTCOMES,EUROPEAN UROLOGY, VOLUME 85, ISSUE 5, 2024, PAGES 445-456, ISSN 0302-2838. HTTPS://DOI.ORG/10.1016/J.EURURO.2023.11.012." } ], "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": "" } ] }