{ "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": "2955842-2025-27894", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250701", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250602", "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", "Study", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "408", "date_added": "20250701", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2687531", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250701", "brand_name": "DA VINCI SYSTEMS", "generic_name": "DA VINCI SYSTEMS", "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": "UNKNOWN", "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": [ "Arcing", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information", "Arcing", "Adverse Event Without Identified Device or Use Problem", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20250701", "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": [ "Burn(s)", "Hematoma", "Cardiovascular Dysfunction/Insufficiency", "Burn(s)", "Hematoma", "Cardiovascular Dysfunction/Insufficiency" ] } ], "distributor_city": "", "date_report": "20250610", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22372191", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250610", "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": "373814192", "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. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: BUFFI, N. M., PICCOLINI, A., MORETTO, S., PACIOTTI, M., FINOCCHIARO, A., CELLA, L., DAGNINO, F., AVOLIO, P. P., FASULO, V., CASALE, P., SAITA, A., LAZZERI, M., HURLE, R., ULERI, A., CRIVELLARO, S., & LUGHEZZANI, G. (2025). RELIABILITY OF THE DA VINCI ROBOTIC SURGICAL SYSTEM: A SYSTEMATIC REVIEW AND POOLED ANALYSIS OF TECHNICAL FAILURES. WORLD JOURNAL OF UROLOGY, 43(1). HTTPS://DOI.ORG/10.1007/S00345-025-05732-Z." }, { "mdr_text_key": "373814193", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A SYSTEMATIC LITERATURE SEARCH WAS CONDUCTED USING PUBMED/MEDLINE, EMBASE, WEB OF SCIENCE, AND SCOPUS TO IDENTIFY STUDIES PUBLISHED UP TO NOVEMBER 2024. A REVIEW OF THE LITERATURE ARTICLE, ¿RELIABILITY OF THE DA VINCI ROBOTIC SURGICAL SYSTEM: A SYSTEMATIC REVIEW AND POOLED ANALYSIS OF TECHNICAL FAILURES¿ WAS PERFORMED AND 3,308,134 PROCEDURES WERE REVIEWED WITH 1,799 REPORTED EVENTS FROM 25 STUDIES. ALL THE INCLUDED STUDIES WERE RETROSPECTIVE, COVERING PROCEDURES PERFORMED BETWEEN 2000 AND 2021. THE POOLED MALFUNCTION RATE WAS 1.0% (95% CI: 0.9-1.2%). THE POOLED RATE OF DEVICE MALFUNCTIONS WAS 0.1% (95% CI: 0.1%-0.1%); INSTRUMENT MALFUNCTIONS ACCOUNTED FOR 0.4% (95% CI: 0.3-0.5%). THE OVERALL MALFUNCTION-RELATED CONVERSION RATE WAS 0.09% (95%CI: 0.06-0.11%), WITH CONVERSION TO OPEN AND LAPAROSCOPIC SURGERY IN 0.1% AND 0.04% OF THE TOTAL PROCEDURES, RESPECTIVELY. THE POOLED RATE OF MALFUNCTION-RELATED INJURIES WAS 0.01% (95% CI: 0.01-0.02%), WITH NO SIGNIFICANT IMPACT ON PATIENT OUTCOMES. NINETEEN STUDIES REPORTED DATA ON TECHNICAL FAILURES OF THE DA VINCI ROBOTIC SYSTEM, INCLUDING COMPLETE INFORMATION ON THE TOTAL NUMBER OF SURGERIES PERFORMED AND THE CORRESPONDING MALFUNCTIONS OBSERVED. ROBOTIC SYSTEM MALFUNCTIONS ENCOMPASSED FAILURES AFFECTING THE ENTIRE PLATFORM, INCLUDING THE PATIENT CART, INSTRUMENTS, AND CONSOLE. INJURY RATES RANGED FROM 0.01 TO 1.39%, WITH THE MAJORITY (193 CASES) ATTRIBUTED TO ELECTRICAL ARCING, RESULTING IN TISSUE DAMAGE OR BURNS. ONLY A MINORITY WERE REPORTED AS SERIOUS INJURIES, INCLUDING VASCULAR AND ORGAN DAMAGE. THIS SYSTEMATIC REVIEW AND ANALYSIS WAS THE FIRST TO REPORT THE MALFUNCTIONS RATE OF THE DA VINCI ROBOTIC SYSTEM, EMPHASIZING THE RELIABILITY OF THE PLATFORM. PER THE AUTHORS, FINDINGS CONFIRM THE DA VINCI SYSTEM¿S OVERALL RELIABILITY. INSTRUMENT MALFUNCTIONS ARE MOST COMMON BUT RARE, WITH MINIMAL NEED FOR SURGICAL CONVERSION. INJURIES ARE UNCOMMON. THE STUDY OFFERS A BENCHMARK FOR EVALUATING NEW ROBOTIC PLATFORMS." } ], "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": "" } ] }