{ "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": "2955842-2024-17486", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240812", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240104", "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": "CA", "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": "2204869", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240812", "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": "", "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": "20240812", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "34 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Ascites", "Ascites" ] } ], "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": "19968941", "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": "349124202", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. 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 XI AND SI SYSTEM WERE MENTIONED IN THE ARTICLE, THEREFORE, THE PRODUCT IS REPORTED AS NOT APPLICABLE (N/A). SOURCE: J. CHAVARRIAGA, E.G. ATENAFU, A. MOUSA ET AL., PROPENSITY-MATCHED ANALYSIS OF OPEN VERSUS ROBOTIC PRIMARY RETROPERITONEAL LYMPH NODE DISSECTION FOR CLINICAL STAGE II TESTICULAR CANCER, EUR UROL ONCOL (2024), HTTPS://DOI.ORG/10.1016/J.EUO.2024.01.006." }, { "mdr_text_key": "349124203", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A REVIEW OF A CLINICAL LITERATURE ARTICLE THAT COMPARED SURVIVAL AND PERIOPERATIVE OUTCOMES OF OPEN VERSUS ROBOTIC RETROPERITONEAL LYMPH NODE DISSECTION (RPLD), THE FOLLOWING COMPLICATIONS WERE DOCUMENTED. A TOTAL OF 178 PATIENTS UNDERWENT PRIMARY RPLD IN ONE SINGLE INSTITUTION BETWEEN 1990 AND 2022, 137 PATIENTS UNDERWENT OPEN-RPLD AND 41 PATIENTS UNDERWENT ROBOTIC-RPLD. AFTER PROPENSITY SCORE MATCHING (PSM), 38 PATIENTS IN THE OPEN-RPLD WERE MATCHED WITH 26 PATIENTS IN THE ROBOTIC-RPLD GROUP. ROBOTIC-RPLD WAS ASSOCIATED WITH LOWER BLOOD LOSS AND STATISTICALLY SHORTER LENGTH OF STAY, COMPARED TO THE OPEN-RPLD GROUP. THE OPERATIVE TIME WAS SIGNIFICANTLY LONGER FOR THE ROBOTIC APPROACH, BUT DECREASED AS SURGEON'S EXPERIENCES GAINED. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS OR DA VINCI DEVICE MALFUNCTION OCCURRED IN ANY OF THE PROCEDURES ACCORDING TO THE ARTICLE AUTHOR. THERE WERE TEN (24%) POST-OPERATIVE COMPLICATIONS OCCURRED IN ROBOTIC-RPLD GROUP COMPARED TO 31 (23%) COMPLICATIONS IN THE OPEN-RPLD GROUP. IN THE ROBOTIC-RPLD GROUP, ONE (2.4%) COMPLICATION OF ASCITES THAT REQUIRED PARACENTESIS WAS REPORTED AS CLAVIDEN-DINDO IIIA, WHILE THE REST OF THE COMPLICATIONS WERE CLAVIDEN-DINDO GRADE II OR LOWER. THE DESIGNATED AUTHOR WAS CONTACTED AND IT WAS STATED THAT ASCITES WERE KNOWN COMPLICATIONS OF RPLD REGARDLESS OF SURGICAL MODALITY. NO ADDITIONAL INFORMATION IS AVAILABLE ACCORDING TO THE ARTICLE AUTHOR." } ], "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": "" } ] }