{ "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": "2955842-2025-20443", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250516", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241211", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20250516", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2207735", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250516", "brand_name": "DA VINCI", "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": "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": "20250516", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "66 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Infection", "Unspecified Infection" ] } ], "distributor_city": "", "date_report": "20250422", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22035951", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250422", "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": "370450860", "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. LAKMAL MAC, SELVASEKAR CR, AGGARWAL S, ET AL., ROBOTIC MULTIVISCERAL RESECTION (RMVR) OF THE PELVIS FOR LOCALLY ADVANCED COLORECTAL CARCINOMA: SINGLE ONCOSURGICAL CENTER EXPERIENCE. SOUTH ASIAN J CANCER 2024;00(00):00¿00. DOI HTTPS://DOI.ORG/10.1055/S-0044-1791561 ISSN 2278-330X. SECTION B3: THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. SECTION D4: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON BOTH DA VINCI S AND SI SYSTEMS. THERE WAS NO DIFFERENTIATION PROVIDED REGARDING WHICH SYSTEM WAS USED FOR THE PROCEDURES. THEREFORE, THE PRODUCT IS REPORTED AS NOT AVAILABLE." }, { "mdr_text_key": "370450861", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE WAS CONDUCTED WHICH EVALUATED PATIENTS WHO UNDERWENT ROBOTIC MULTI-VISCERAL RESECTION (RMVR) FOR A PRIMARY COLORECTAL CARCINOMA. THE RETROSPECTIVE STUDY ANALYZED 24 PATIENTS WHO UNDERWENT RMVR BETWEEN 2012 TO 2022. A TOTAL OF SIX PATIENTS EXPERIENCED COMPLICATIONS, CLAVIEN-DINDO GRADE III OR HIGHER, WHICH INCLUDED PELVIC FLUID COLLECTIONS NEEDING RADIOLOGICAL DRAINAGE AND INFECTIONS OF THE PERINEAL WOUND/FLAP NEEDING DRAINAGE UNDER LOCAL ANESTHESIA. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY EVENTS TO A DA VINCI DEVICE OR PRODUCT. THE STUDY CONCLUDED THAT FOR ADVANCED COLORECTAL CANCER, RMVR IS A SAFE AND ATTAINABLE PROCESS. ADDITIONAL INFORMATION WAS PROVIDED THROUGH FOLLOW-UP FROM THE CORRESPONDING AUTHOR: THE OPERATIONS DISCUSSED ARE COMPLEX AND THESE ARE EXPECTED FOR THIS GROUP OF PTS AND FOLLOWING NEOADJUVANT TREATMENT." } ], "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": "" } ] }