{ "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": "2955842-2025-16240", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250423", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241004", "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": "20250423", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2070358", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250423", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL SYSTEM", "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": "IL", "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": "20250423", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250401", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21890186", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250401", "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": "368725557", "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: LAMBERTINI, L., PACINI, M., CALVO,R.S., ET AL. EXTRAPERITONEAL SINGLE PORT VS TRANSPERITONEAL MULTIPORT ROBOT ASSISTED RADICAL PROSTATECTOMY IN FRAIL PATIENTS: A PROPENSITY SCORE MATCHED COMPARATIVE ANALYSIS, EUROPEAN JOURNAL OF SURGICAL ONCOLOGY, VOLUME 50, ISSUE 12, 2024, 108741, ISSN 0748-7983, HTTPS://DOI.ORG/10.1016/J.EJSO.2024.108741. SECTION A2: REFLECTS THE STUDY MEAN AGE OF 64 YEARS. THE AGE RANGE WAS 60-68 YEARS. SECTION D4: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON BOTH DA VINCI MULTI PORT AND SINGLE PORT SYSTEMS. THERE WAS NO DIFFERENTIATION PROVIDED REGARDING WHICH SYSTEM WAS USED FOR THE PROCEDURES. THEREFORE, THE PRODUCT IS REPORTED AS NOT AVAILABLE. STUDY BODY MASS INDEX (BMI) MEAN 28.1 KG/M2. THE RANGE WAS 26.1-31.3 KG/M2." }, { "mdr_text_key": "368725558", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A COMPARATIVE ANALYSIS BETWEEN MARCH 2014 AND OCTOBER 2023 OF PATIENTS WHO UNDERWENT DA VINCI-ASSISTED RADICAL PROSTATECTOMIES. THE AIM WAS TO COMPARE PERIOPERATIVE AND EARLY SURGICAL OUTCOMES OF EXTRAPERITONEAL SINGLE PORT (SP)- VS TRANSPERITONEAL MULTIPORT (MP) - ROBOT ASSISTED RADICAL PROSTATECTOMY (RARP) IN DIFFERENT FRAILTY SETTINGS. A TOTAL OF 549 PATIENTS WERE ASSESSED IN AN UNMATCHED ANALYSIS. AFTER THE PROPENSITY SCORE, 252 PATIENTS WERE IDENTIFIED. THE PATIENTS (WHO HAD A MEDIAN AGE OF 64 YEARS) WERE SPLIT INTO TWO GROUPS, 126 IN THE SP GROUP AND 126 IN THE MP GROUP. A 5-ITEM MODIFIED FRAILTY INDEX (5-MFI) WAS USED TO IDENTIFY PATIENTS WHO WILL BENEFIT FROM SURGERY AND FORECAST THE RELATED MORBIDITY. THE ANALYSIS REPORTED, OF THE 252 PATIENTS, THERE WAS A TOTAL OF 5 INTRAOPERATIVE COMPLICATIONS, 1 OPEN CONVERSION, AND 27 30-DAYS POSTOPERATIVE COMPLICATIONS WITH A CLAVIEN-DINDO GRADE III OR HIGHER. THE SPECIFICS OF THE COMPLICATIONS AND CONVERSION (AND ANY REQUIRED MEDICAL INTERVENTIONS) WERE NOT REPORTED IN THE ARTICLE. THE MP RARP GROUP (COMPARED TO THE SP RARP GROUP) HAD HIGHER INCIDENCES OF INTRAOPERATIVE COMPLICATIONS (4 VS. 1) OPEN CONVERSIONS (1 VS. 0) AND 30-DAYS POSTOPERATIVE COMPLICATIONS OF CLAVIEN-DINDO GRADE III OR HIGHER (14 VS. 13). THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURES AND NO ALLEGATION THAT A DA VINCI DEVICE CAUSED OR CONTRIBUTED TO THE EVENTS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORRESPONDING AUTHOR OF THE ARTICLE. IT WAS REPORTED THAT UNFORTUNATELY THE RETROSPECTIVE NATURE OF THE STUDY HINDERS TO FIND SEVERAL OF THE REQUESTED INFORMATION. IT WAS CONFIRMED THAT NONE OF THE REPORTED COMPLICATIONS WERE ASSOCIATED WITH DEVICE MALFUNCTIONS." } ], "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": "" } ] }