{ "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": "2955842-2024-18056", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240813", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20231220", "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": "NL", "manufacturer_contact_area_code": "408", "date_added": "20240813", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1895640", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240813", "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": "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": "10/10/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20240813", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "48 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Thrombosis/Thrombus", "Bacterial Infection", "Thrombosis/Thrombus" ] } ], "distributor_city": "", "date_report": "20240717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19973705", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240717", "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": "356517664", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ARTICLE AUTHOR STATED THAT THE DESCRIBED LYMPHOCELES IN THE ARTICLE WERE NOT RELATED TO THE DA VINCI SYSTEMS, BUT RELATED TO THE PROCEDURES PERFORMED." }, { "mdr_text_key": "356517665", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "349162693", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE IS INSUFFICIENT INFORMATION ON THE PROCEDURE DATE AND THUS A SYSTEM LOG WAS NOT AVAILABLE TO BE PERFORMED. THERE IS ALSO INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT THE PROCEDURE HAD COMPLICATION, AS BOTH DA VINCI X/XI AND SI SYSTEM WERE MENTIONED IN THE ARTICLE WITHOUT THE SPECIFIC PRODUCT INFORMATION. THEREFORE, THE PRODUCT IS REPORTED AS A N/A (FOR REGULATORY USE). SOURCE: DE JONG A, BAETEN IGT, JANSEN A, HOOGENDAM JP, JÜRGENLIEMK-SCHULZ IM, ZWEEMER RP, GERESTEIN CG. SYMPTOMATIC LYMPHOCELE AFTER ROBOT-ASSISTED PELVIC LYMPHADENECTOMY AS PART OF THE PRIMARY SURGICAL TREATMENT FOR CERVICAL AND ENDOMETRIAL CANCER: A RETROSPECTIVE COHORT STUDY. J MINIM INVASIVE GYNECOL. 2024 MAR;31(3):243-249.E2. DOI: 10.1016/J.JMIG.2023.12.010. EPUB 2024 JAN 1. PMID: 38171478." }, { "mdr_text_key": "349162694", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A REVIEW OF A CLINICAL LITERATURE ARTICLE THAT INVESTIGATED THE INCIDENCE AND RISK FACTORS OF SYMPTOMATIC LYMPHOCELE POST ROBOTIC-ASSISTED PELVIC LYMPH NODE DISSECTION (PLND), THE FOLLOWING EVENTS WERE MENTIONED. A TOTAL OF 387 PATIENTS THAT UNDERWENT ROBOTIC ASSISTED PLND WERE INCLUDED IN THE STUDY, THE INCIDENCE OF SYMPTOMATIC LYMPHOCELE WAS 9.6% (37 PATIENTS). 27 PATIENTS WITH CERVICAL CANCER AND 10 PATIENTS WITH ENDOMETRIAL CANCER. A SYMPTOMATIC LYMPHOCELE IS DEFINED AS A LYMPHOCELE VISIBLE ON IMAGING WITH THE PRESENCE OF SYMPTOMS CAUSED BY COMPRESSION OF ADJACENT STRUCTURES, PELVIC PAIN, INFECTION OR DEEP VEIN THROMBOSIS. ONE PATIENT DEVELOPED A DEEP VENOUS THROMBOSIS AS A RESULT OF A LYMPHOCELE, WITHOUT THE NEED OF INVASIVE INTERVENTION AND WAS CLASSIFIED AS GRADE 2. THERE WERE 36 PATIENTS CONSIDERED AS GRADE 3 SYMPTOMATIC LYMPHOCELE REQUIRED HOSPITALIZATION. THE MEDIAN LENGTH OF HOSPITALIZATION WAS 8 DAYS. AMONG THE 36 PATIENTS, 8 PATIENTS REQUIRED INTRAVENOUS ANTIBIOTICS, 28 PATIENTS REQUIRED DRAINAGE IN ADDITION TO ANTIBIOTICS. ONE OF THE PATIENTS HAD RECURRENT SYMPTOMATIC LYMPHOCELE AND REQUIRED ANTIBIOTICS TREATMENT REPEATEDLY AS THE LOCATION WAS HARD TO DRAIN. SMOKING, AGE, BODY MASS INDEX (BMI) AND HISTORY OF PRIOR ABDOMINAL SURGERY WERE IDENTIFIED AS RISK FACTORS IN EITHER THE COHORTS OR IN THE PATIENTS HAD CERVIX OR ENDOMETRIAL CANCER. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS OCCURRED DURING THE ROBOTIC ASSISTED SURGERIES." } ], "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": "11/06/2024" } ] }