{ "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": "2955842-2024-20289", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241010", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20231207", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20241010", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "344632", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241010", "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": "20250821", "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": "20241010", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "50 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Unspecified Vascular Problem", "Hemorrhage/Blood Loss/Bleeding", "Unspecified Vascular Problem" ] } ], "distributor_city": "", "date_report": "20240916", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20423134", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240916", "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": "353927009", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE CAUSES OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR THE DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. CITATION: AIKO, K., KANNO, K., YANAI, S., SAWADA, M., SAKATE, S., ANDOU, M. (2023) ROBOT-ASSISTED VERSUS LAPAROSCOPIC SURGERY FOR PELVIC LYMPH NODE DISSECTION IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES DOI: 10.4103/GMIT.GMIT_9_23. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. NO SPECIFIC DEMOGRAPHICS WERE PROVIDED FOR THE PATIENTS. STUDY DEMOGRAPHICS IN THE ROBOTIC GROUP INCLUDED 271 PATIENTS WITH A MEDIAN AGE OF 50 YEARS AND MEDIAN BMI OF 23.4. IN SECTION D4, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS, THUS, THE PRODUCT IS REPORTED AS NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. SECTION D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. SECTIONS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "353927010", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A STUDY WHICH COMPARED ROBOT-ASSISTED VERSUS LAPAROSCOPIC LYMPH NODE DISSECTION PROCEDURES IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES, WAS SUMMARIZED IN A LITERATURE ARTICLE. THE ARTICLE COMPARES THE SURGICAL OUTCOMES AND COMPLICATIONS FOR PELVIC LYMPH NODE DISSECTION (PLND) PERFORMED THROUGH CONVENTIONAL LAPAROSCOPIC SURGERY (CLS) VERSUS ROBOT-ASSISTED SURGERY (RAS) IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES OVER A PERIOD OF APPROXIMATELY EIGHT YEARS. THERE WERE 731 PATIENTS WITH GYNECOLOGIC MALIGNANCIES WHO UNDERWENT TRANSPERITONEAL PLND, INCLUDING 460 AND 271 IN THE CLS AND RAS GROUPS, RESPECTIVELY. THE BLOOD LOSS, AND NUMBER OF RESECTED LYMPH NODES WERE 110 +/- 88 ML, AND 45 +/- 17, RESPECTIVELY, IN THE RAS GROUP AND 89 +/- 78 ML, AND 38 +/- 16, RESPECTIVELY, IN THE CLS GROUP. IT WAS CONSIDERED THAT THE DIFFERENCE IN BLOOD LOSS (APPROXIMATELY 20 ML) WAS WITHIN A CLINICALLY ACCEPTABLE RANGE AND RAS RESULTS IN THE RESECTION OF A GREATER NUMBER OF PELVIC LYMPH NODES. THE RATE OF CLAVIEN-DINDO GRADE >/= III COMPLICATIONS WAS 6.3% AND 8.7% IN THE RAS AND CLS GROUPS, RESPECTIVELY. ONE PATIENT IN THE RAS GROUP, COMPARED WITH 4 IN THE CLS GROUP, HAD AN INTRAOPERATIVE VASCULAR COMPLICATION WHICH WAS MANAGED ENDOSCOPICALLY WITH NO BLOOD TRANSFUSION OR CONVERSION TO LAPAROTOMY. ADDITIONALLY, IN THE RAS GROUP, 6 PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS OF SYMPTOMATIC LYMPHOCELES COMPARED TO 15 PATIENTS IN THE CLS GROUP. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHORS; HOWEVER, NO RESPONSE WAS RECEIVED. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE." } ], "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": "" } ] }