{ "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": "2955842-2026-14973", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260306", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250416", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20260306", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "589507", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260306", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260306", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260306", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "56 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Wound Infection", "Thrombosis/Thrombus" ] } ], "distributor_city": "", "date_report": "20260209", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24531148", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260209", "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": "394815425", "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. CITATION: ZHANG, Y., ET AL. (2025). COMPARISONS OF EFFICIENCY, SAFETY, AND HOSPITAL COSTS OF FOUR-ARM ROBOTIC-ASSISTED PARTIAL NEPHRECTOMY (RAPN) VERSUS THREE-ARM TECHNIQUE: A PROPENSITY SCORE-MATCHED ANALYSIS. JOURNAL OF CLINICAL MEDICINE, 14, 2739. HTTPS://DOI.ORG/10.3390/JCM14082739. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEDIAN AGE OF 56 YEARS. SECTION A3A- MALE GENDER REPRESENTS THE MAJORITY (71.4%) OF THE PATIENTS. SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS IN THE ROBOTIC GROUP COHORT. SECTION D: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT." }, { "mdr_text_key": "394815426", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE THAT EVALUATED THE DIFFERENCES IN EFFICIENCY, SAFETY, AND HOSPITAL COSTS BETWEEN THREE-ARM AND FOUR-ARM ROBOTIC-ASSISTED PARTIAL NEPHRECTOMY (RAPN) WAS PERFORMED. THE RETROSPECTIVE STUDY ANALYZED THE CLINICAL DATA OF 91 PATIENTS UNDERGOING RAPN BETWEEN JANUARY 2021 TO DECEMBER 2023. ONE PATIENT FROM EACH OF THE TWO GROUPS DEVELOPED A CLAVIEN-DINDO GRADE 3 COMPLICATION OF POST-OPERATIVE BLEEDING, REQUIRING ANGIOEMBOLIZATION. TWO PATIENTS IN THE FOUR-ARM GROUP DEVELOPED DEEP VEIN THROMBOSIS, REQUIRING PLACEMENT OF AN INFERIOR VENA CAVA FILTER, AND THREE PATIENTS EXPERIENCED POST-OPERATIVE WOUND INFECTIONS. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, AND NO INDICATION THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. ISI MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO INFORMATION HAS BEEN OBTAINED AT THE TIME 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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }