{ "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": "2955842-2025-14028", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250411", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240501", "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", "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": "20250411", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2572126", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250411", "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": "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": "AL", "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": "20250411", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Hospitalization", " R" ], "patient_age": "67 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Shock", "Respiratory Failure", "Bowel Perforation", "Shock", "Respiratory Failure", "Bowel Perforation" ] } ], "distributor_city": "", "date_report": "20250317", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21827257", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250317", "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": "368011142", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY TO COMPARE THE OUTCOMES OF 96 PATIENTS UNDERGOING ROBOTIC-ASSISTED RADICAL CYSTECTOMY (RARC) WITH URINARY DIVERSION FOR BLADDER CANCER. THE STUDY AIMED TO EVALUATE THE POSTOPERATIVE OUTCOMES AND ANALGESIC REQUIREMENTS OF SINGLE-PORT (SP) VS MULTIPORT ROBOTIC-ASSISTED RADICAL CYSTECTOMY (MP RARC). IN THE SP COHORT, THERE WERE SEVEN CLAVIEN IV COMPLICATIONS (TWO CARDIAC ARRHYTHMIAS AND SHOCK, THREE SEPTIC SHOCKS, ONE RESPIRATORY FAILURE, AND ONE BOWEL PERFORATION), AND FOUR CLAVIEN III COMPLICATIONS (ONE INCISIONAL HERNIA REPAIR, ONE GASTRIC TUBE PLACEMENT FOR CANCER RECURRENCE, ONE HYDRONEPHROSIS WITH ASSOCIATED ACUTE KIDNEY INJURY REQUIRING A NEPHROSTOMY TUBE, AND ONE INTRAABDOMINAL ABSCESS REQUIRING DRAIN PLACEMENT) WERE NOTED. THE STUDY CONCLUDED THAT THE SP ROBOTIC PLATFORM OFFERS A SAFE ALTERNATIVE TO THE MP ROBOTIC PLATFORM IN PERFORMING RARC WITH URINARY DIVERSION. NO CLINICALLY SIGNIFICANT DIFFERENCE WAS DEMONSTRATED IN PERIOPERATIVE OR ONCOLOGIC OUTCOMES. THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHORS ALLEGE THAT ANY INTUITIVE PRODUCTS CAUSED OR CONTRIBUTED TO THE INJURIES. THE DESIGNATED AUTHOR WAS CONTACTED, AND NO ADDITIONAL INFORMATION WAS RECEIVED." }, { "mdr_text_key": "368011143", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION COULD NOT BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATES OR DA VINCI SYSTEM IDENTIFIERS. THERE WERE NO DEVICE ISSUES DOCUMENTED IN THE ARTICLE. CITATION: FANG, A. M., HAYEK, O., KAYLOR, J. M., PEYTON, C. C., FERGUSON, J. E., NIX, J. W., & RAIS-BAHRAMI, S. (2024). POSTOPERATIVE OUTCOMES AND ANALGESIC REQUIREMENTS OF SINGLE-PORT VS MULTIPORT ROBOTIC-ASSISTED RADICAL CYSTECTOMY. JOURNAL OF ENDOUROLOGY, 38(5), 438¿443. HTTPS://DOI.ORG/10.1089/END.2023.0553. SECTION A2 AGE: THE MEAN AGE OF ALL PATIENTS WAS 67 YEARS OLD. SECTION A3 GENDER: MALE - 83%; FEMALE - 17%." } ], "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": "" } ] }