{ "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": "2955842-2025-47174", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251209", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250420", "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": "IT", "manufacturer_contact_area_code": "408", "date_added": "20251209", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2122931", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251209", "brand_name": "DA VINCI SURGICAL SYSTEM", "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": "20260129", "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": "20251209", "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": [ "Sepsis", "Unspecified Tissue Injury", "Pneumoperitoneum", "Sepsis", "Unspecified Tissue Injury", "Pneumoperitoneum" ] } ], "distributor_city": "", "date_report": "20251209", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23763760", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251111", "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": "387243430", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF THE ARTICLE WAS CONDUCTED WHICH AIMED TO EVALUATE THE FEASIBILITY, REPRODUCIBILITY, AND SAFETY OF ADRENALECTOMY PROCEDURES PERFORMED USING THE DA VINCI SINGLE-PORT (DV-SP) ROBOTIC SYSTEM. THE STUDY DESIGN WAS A SYSTEMATIC REVIEW AND POOLED ANALYSIS OF FIVE RETROSPECTIVE STUDIES INVOLVING 342 PATIENTS WHO UNDERWENT ROBOT-ASSISTED ADRENALECTOMY PROCEDURES BETWEEN 2018 AND 2024. DURING THESE DA VINCI SURGERIES, THE ARTICLE REPORTED MULTIPLE COMPLICATIONS. ONE PATIENT HAD A GRADE IIIB CLAVIEN¿DINDO COMPLICATION IDENTIFIED ON POSTOPERATIVE DAY #6. THE PATIENT DEVELOPED SEPSIS WITH A TRANSIENT IPSILATERAL URETEROPELVIC JUNCTION (UPJ) OBSTRUCTION DUE TO EDEMA NEAR THE UPJ, WHICH REQUIRED THE PLACEMENT OF A URETERAL STENT FOR 6 WEEKS. ANOTHER PATIENT IN THE DA VINCI MULTI-PORT (MP) GROUP, DEVELOPED A CLAVIEN¿DINDO IIIB COMPLICATION CONSISTING OF PNEUMOPERITONEUM WHICH REQUIRED A SURGICAL DRAIN PLACEMENT. CONVERSION TO LAPAROSCOPY WAS REQUIRED IN ONLY TWO CASES AMONG PATIENTS UNDERGOING SINGLE-PORT ROBOT-ASSISTED ADRENALECTOMY (SA RAA), WHILE AN ADDITIONAL PORT FOR LIVER RETRACTION WAS NEEDED IN THE ONLY TRANSPERITONEAL DV-SP RAA CASE. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY THE DV-SP ROBOTIC SYSTEM. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "387243431", "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: REITANO, G., ET AL. (2025). ADRENALECTOMY PERFORMED WITH THE DA VINCI SINGLE-PORT ROBOTIC SYSTEM: A SYSTEMATIC REVIEW AND POOLED ANALYSIS. CANCERS, 17(8), 1372. HTTPS://DOI.ORG/10.3390/CANCERS17081372. SECTION B4 CURRENTLY CAPTURES THE DATE OF THE MEDWATCH SUBMISSION TO THE FDA. THE DATE THAT THE LITERATURE ARTICLE FIRST CAME TO THE ATTENTION OF INTUITIVE WAS 11-NOV-2025. 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." } ], "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": "" } ] }