{ "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": "2955842-2025-34881", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250821", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250605", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250821", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2782780", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250821", "brand_name": "DA VINCI SURGICAL SYSTEM", "generic_name": "DA VINCI SURGICAL SYSTEMS", "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": "20250926", "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": "20250821", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Septic Shock", "Unspecified Kidney or Urinary Problem", "Septic Shock", "Unspecified Kidney or Urinary Problem" ] } ], "distributor_city": "", "date_report": "20250730", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22865051", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250730", "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": "378283879", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF A LITERATURE ARTICLE \"BENCH SURGERY WITH ROBOT-ASSISTED KIDNEY AUTO-TRANSPLANTATION FOR COMPLEX KIDNEY TUMORS: TECHNIQUE AND OUTCOMES FROM A SINGLE CENTER\" WAS PERFORMED. FROM JANUARY 2018 TO MAY 2021, FOUR PATIENTS WITH SOLITARY KIDNEY TUMORS AND EIGHT WITH BILATERAL KIDNEY TUMORS UNDERWENT BENCH SURGERY (BENS) AND ROBOT-ASSISTED KIDNEY AUTO-TRANSPLANTATION (RAKAT). THE ARTICLE NOTED THAT THAT DURING THESE DV SURGERIES, \"THREE PATIENTS PRESENTED GRADE IV POSTOPERATIVE COMPLICATIONS, AS FOLLOWS: ONE DEVELOPED SEPTIC SHOCK THAT RESOLVED WITH TREATMENT WITH BROAD-SPECTRUM ANTIBIOTICS AND SUPPORTIVE CARE IN THE INTENSIVE CARE UNIT. WHILE OTHER TWO OTHER DEVELOPED DELAYED GRAFT FUNCTION (DGF) THAT RESOLVED WITH TEMPORARY DIALYSIS.\" THE AUTHORS CONCLUDED THAT BENS WITH RAKAT IS AN ALTERNATIVE STRATEGY FOR THE TREATMENT OF HIGH-COMPLEXITY RENAL TUMORS THAT ARE UNSUITABLE FOR IN SITU PARTIAL NEPHRECTOMY (PN). LARGER PROSPECTIVE STUDIES WITH LONGER FOLLOW-UP ARE REQUIRED TO FURTHER ASSESS THE FINDINGS. 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. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED." }, { "mdr_text_key": "378283880", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO INVESTIGATION COULD BE PERFORMED AS 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 WAS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: FAN, Y., DONG, J., WANG, H., ZU, Q., LIU, K., ZHU, J., WANG, B., HUANG, Q., GAO, Y., CHEN, X., ZHAO, J., HAO, X., ZHU, Q., HUANG, S., MA, X., & ZHANG, X. (2025). BENCH SURGERY WITH ROBOT-ASSISTED KIDNEY AUTOTRANSPLANTATION FOR COMPLEX KIDNEY TUMORS: TECHNIQUE AND OUTCOMES FROM A SINGLE CENTER. EUROPEAN UROLOGY OPEN SCIENCE, 74, 1¿10. HTTPS://DOI.ORG/10.1016/J.EUROS.2025.01.018. PATIENT DEMOGRAPHIC INFORMATION: AGE: MEDIAN INTERQUARTILE RANGE (IQR) 47 TO 57 YEARS. GENDER: FEMALE (10) AND MALE (14); BODY MASS INDEX (BMI): MEDIAN IQR 24.4 (22.4¿26.1) KG/M2." } ], "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": "" } ] }