{ "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": "2955842-2025-17501", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250508", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20241217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "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": "DA", "manufacturer_contact_area_code": "408", "date_added": "20250508", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "468318", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250508", "brand_name": "DA VINCI SURGICAL SYSTEM", "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": "UNKNOWN", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "06/13/2025", "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": "20250508", "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": [ "Ischemia", "Urinary Retention", "Obstruction/Occlusion", "Ischemia", "Urinary Retention", "Obstruction/Occlusion" ] } ], "distributor_city": "", "date_report": "20250415", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21984351", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250415", "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": "375499518", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: ANNEX E. UPDATED CODES: E1309 - URINARY RETENTION. E0509 - ISCHEMIA." }, { "mdr_text_key": "375499519", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "369804963", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. ERIKSEN, J. R., BRISLING, S. K., AND GOGENUR, I. (2024). INITIAL EXPERIENCE AND RESULTS OF ROBOTIC LATERAL PELVIC LYMPH NODE DISSECTION IN LOCALLY ADVANCED RECTAL CANCER¿A SINGLE CENTER EXPERIENCE OF 17 CONSECUTIVE PROCEDURES. INTERNATIONAL JOURNAL OF COLORECTAL DISEASE, 39(1). HTTPS://DOI.ORG/10.1007/S00384-024-04782-W, SECTION A: MEDIAN AGE WAS 63 YEARS. MEDIAN BODY MASS INDEX (BMI) OF 25.6 KG/M2." }, { "mdr_text_key": "369804964", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE ¿INITIAL EXPERIENCE AND RESULTS OF ROBOTIC LATERAL PELVIC LYMPH NODE DISSECTION (LPLND) IN LOCALLY ADVANCED RECTAL CANCER - A SINGLE CENTER EXPERIENCE OF 17 CONSECUTIVE PROCEDURES¿ WAS PERFORMED. THE ARTICLE ANALYZED SURGICAL-PATHOLOGIC OUTCOMES IN 17 CONSECUTIVE PATIENTS WHO UNDERWENT ROBOTIC LPLND AND RECTAL RESECTION BETWEEN MAY 2018 AND JUNE 2024. THE MEDIAN AGE WAS 63 YEARS (RANGE 35-79) WITH A MEDIAN BODY MASS INDEX (BMI) OF 25.6 KG/M2 (RANGE 19.4-34.5). SEVEN PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS WITHIN 30 DAYS, WITH ONLY ONE CLAVIEN-DINDO (CD) COMPLICATION GREATER THAN OR EQUAL TO GRADE 3. THIS GRADE 3 POSTOPERATIVE COMPLICATION PATIENT PRESENTED WITH A TOTAL THROMBOEMBOLIC OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY WITH LOWER LIMB ISCHEMIA ON POST-OPERATIVE DAY (POD) 1. THE PATIENT UNDERWENT A SUCCESSFUL ACUTE SUBCLAVIAN-BIFEMORAL BYPASS PROCEDURE. THE OTHER OBSERVED 30-DAY CD 1 AND 2 COMPLICATIONS INCLUDED THE NEED FOR INTRAVENOUS FLUID THERAPY (N=3), SUPERFICIAL PERINEAL WOUND DEHISCENCE (N=1), POSTOPERATIVE URINARY RETENTION (N=2), DEEP VENOUS THROMBOSIS (N=1) AND LYMPHEDEMA (N=2). THE AUTHORS CONCLUDED THAT THIS STUDY SHOWED THAT SIMULTANEOUS ROBOT-ASSISTED LPLND AND RECTAL RESECTION CAN BE PERFORMED SAFELY AND EFFECTIVELY IN SELECTED PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER, WITH A SHORT HOSPITAL STAY AND FEW READMISSIONS AND POSTOPERATIVE COMPLICATIONS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT." } ], "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": "07/01/2025" } ] }