{ "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": "2955842-2025-15510", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250424", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20241126", "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", "Study", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250424", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2086346", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250424", "brand_name": "DA VINCI SP", "generic_name": "PATIENT SIDE CART", "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": "380601", "catalog_number": "380601", "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": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250424", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "54 YR", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Vascular Problem", "Insufficient Information", "Unspecified Vascular Problem", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20250328", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21904142", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250328", "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": "368913473", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE ANALYSIS BETWEEN AUGUST 2020 TO JANUARY 2023 OF 40 PATIENTS WHO UNDERWENT DA VINCI-ASSISTED SINGLE-PORT EXTRAPERITONEAL KIDNEY TRANSPLANTATION (SP EP-KT) PROCEDURES. THE MEDIAN AGE OF ALL PATIENTS WAS 54.45 (46.8-60.3) YEARS. THE MEDIAN BMI WAS 32.1 (29.8-37.4) KG/M2. THE 40 PATIENTS INCLUDED 24 MALES AND 16 FEMALES. THE STUDY WAS CONDUCTED TO EVALUATE \"THE SAFETY AND FEASIBILITY OF THE SURGERY DEFINED AS SUCCESSFUL COMPLETION OF THE TRANSPLANT PROCEDURE WITHOUT ANY CONVERSION, ABORT OF PROCEDURE, OR POSTOPERATIVE GRAFT LOSS.\". ONE CASE REQUIRED CONVERSION TO AN OPEN SURGERY DUE TO POOR ARTERIAL PULSATIONS AFTER COMPLETION OF VASCULAR ANASTOMOSIS WITH A DUSKY COLOR OF THE RENAL PARENCHYMA. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE RECOVERY AND DID NOT HAVE SIGNIFICANT CLINICAL SEQUELAE OR GRAFT FAILURE. THE ARTICLE MENTIONED THERE WERE OTHER MAJOR UNSPECIFIED POSTOPERATIVE COMPLICATIONS (CLAVIEN-DINDO CLASSIFICATION OF GRADE III OR HIGHER) REPORTED IN FIVE PATIENTS IN THE FIRST 90 DAYS. IT WAS ALSO REPORTED THERE WERE 10 OTHER POSTOPERATIVE COMPLICATIONS AND NINE RE-ADMISSIONS WITHIN 90 DAYS OF SURGERY. THERE WAS NO REPORT OF MALFUNCTIONS OF DA VINCI DEVICES DURING THE PROCEDURE AND NO INDICATION THAT AN ISI PRODUCT COULD HAVE CAUSED OR CONTRIBUTED TO THE EVENTS. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE; NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "368913474", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW WAS NOT PERFORMED AS THERE IS INSUFFICIENT OR UNCONFIRMED PRODUCT/EVENT INFORMATION. CITATION: CHAVALI JS, KAOUK J, SOPUTRO N, ELTEMAMY M. SINGLE-PORT EXTRAPERITONEAL ROBOTIC KIDNEY TRANSPLANTATION: EARLY EXPERIENCE OF NOVEL TECHNIQUE. BJU INT. 2025 MAR;135(3):433-436. DOI: 10.1111/BJU.16600. EPUB 2024 NOV 26. PMID: 39588788. IN SECTION A4: PATIENTS MEAN BMI 32.1 KG/M2. THE RANGE WAS 30-37. IN SECTION A2: THE PATIENT AGE REFLECTS THE MEAN AGE OF 55 YEARS. THE AGE RANGE WAS 47-60 YEARS. IN SECTION B3: THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. IN SECTION D4: THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE SPECIFIC SYSTEM THAT WAS USED DURING THE PROCEDURES WITH COMPLICATIONS; THUS, A GENERIC SP SYSTEM WAS REPORTED." } ], "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": "" } ] }