{ "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": "2955842-2023-16582", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230624", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230320", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230624", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1000920", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230624", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-44", "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": "R", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20230624", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Air Embolism", "Unspecified Tissue Injury", "Insufficient Information", "Air Embolism", "Unspecified Tissue Injury", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20230526", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17195906", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230526", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "317810800", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATIONS CANNOT BE DETERMINED. THERE IS NO STATEMENT OR INDICATION OF ANY ISSUES WITH THE DAVINCI ROBOTIC SYSTEMS. SECTION A2 PATIENT AGE: AGE RANGE FOR THE SP SYSTEM POPULATION: (Y), X +/- SD: 69.0 +/- 7.8. AGE RANGE FOR THE MP SYSTEM: 70.8 +/- 7.5. SECTION B4 PATIENT WEIGHT: BODY MASS INDEX (BMI) RANGE FOR THE SP SYSTEM POPULATION: (KG/M2, X +/- SD: 28.0 +/- 6.1. BMI RANGE FOR THE MP SYSTEM: 27.9 +/- 4.8. SECTION D: THE ARTICLE COMPARES THE DA VINCI SINGLE PORT (SP) TO THE DA VINCI XI MULTIPORT (MP) ROBOTIC SYSTEMS FOR SIMPLE PROSTATECTOMY PROCEDURES. THERE IS MINIMAL INFORMATION PROVIDED, THUS THIS MEDWATCH REPORT REPRESENTS BOTH DA VINCI SYSTEMS COMPARATOR DETAILS AND THE NUMBER OF EVENTS PER THE CLAVIEN-DINDO CLASSIFICATION GRADE LISTINGS, FROM MARGINAL (GRADE I) TO SERIOUS INJURY (GRADE IVB). SECTION E: THERE WERE 5 PARTICIPATING CENTERS: GLICKMAN UROLOGICAL & KIDNEY INSTITUTE, CLEVELAND CLINIC, CLEVELAND, OH; THE MOUNT SINAI HOSPITAL, NEW YORK, NY; THE HACKENSACK MERIDIAN HEALTH, HACKENSACK, NJ; THE HENRY FORD HEALTH, DETROIT, MI; AND THE UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM, CHICAGO, IL. ARTICLE CITATION: ZEINAB MA, RAMOS R, FERGUSON EL, ET AL. SINGLE PORT VERSUS MULTIPORT ROBOT-ASSISTED SIMPLE PROSTATECTOMY: A MULTI-INSTITUTIONAL STUDY FROM THE SINGLE-PORT ADVANCED RESEARCH CONSORTIUM (SPARC). UROLOGY. 2023. HTTPS://DOI.ORG/10.1016/J.UROLOGY.2023.03.022." }, { "mdr_text_key": "317810801", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING REVIEW OF A LITERATURE ARTICLE INVOLVING DA VINCI-ASSISTED ROBOTIC PROCEDURES TITLED, ¿SINGLE PORT VERSUS MULTIPORT ROBOT-ASSISTED SIMPLE PROSTATECTOMY: A MULTI-INSTITUTIONAL STUDY FROM THE SINGLE-PORT ADVANCED RESEARCH CONSORTIUM (SPARC)¿ THE FOLLOWING EVENTS WERE REPORTED. A MULTI-INSTITUTIONAL STUDY EVALUATED AND COMPARED 405 PATIENTS WHO UNDERWENT DA VINCI ROBOTIC-ASSISTED SINGLE PORT (SP) AND MULTIPORT (MP) SIMPLE PROSTATECTOMY BETWEEN JANUARY 2017 AND OCTOBER 2022. AMONG THOSE PATIENTS, 249 UNDERWENT PROCEDURES USING THE MULTIPORT DAVINCI XI SYSTEM, AND 156 UNDERWENT PROCEDURES USING THE SINGLE PORT DAVINCI SP SYSTEM. THERE WERE 5 PATIENTS WITH INTRAOPERATIVE COMPLICATIONS ASSOCIATED WITH THE USE OF THE SINGLE PORT DA VINCI SP SYSTEMS. FOUR OF THE PATIENTS EXPERIENCED AIR EMBOLI, AND ONE PATIENT EXPERIENCED A POSTERIOR CYSTOTOMY. OTHER THAN THE 4 AIR EMBOLI AND 1 POSTERIOR CYSTOTOMY, THE ARTICLE DOES NOT PROVIDE ANY SPECIFIC INFORMATION ON THE NATURE OR SEVERITY OF THE COMPLICATIONS OTHER THAN THE TABLE 2 CLAVIEN-DINDO CLASSIFICATIONS WHICH DOCUMENTS THE FOLLOWING: GRADE I: 6 EVENTS / GRADE II: 5 EVENTS / GRADE IVA: 1 EVENT. COMPLICATIONS ENCOUNTERED FOR THE PROCEDURES PERFORMED WITH THE DA VINCI XI (MP) SYSTEMS ARE ONLY LISTED IN TABLE 2 AS NUMBER OF PATIENTS PER EACH CLAVIEN-DINDO CLASSIFICATION. THE ARTICLE DOES NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE NATURE OF THE COMPLICATIONS, INCLUDING THOSE OF HIGHER SEVERITY GRADES. THE CLAVIEN-DINDO CLASSIFICATIONS INCLUDE THE FOLLOWING: GRADE I: 14 EVENTS / GRADE 2: 24 EVENTS / GRADE IIIA: 2 EVENTS / GRADE IIIB: 4 EVENTS / GRADE IVA: 2 EVENTS / GRADE VIB: 1 EVENT. THE MEDIAN ESTIMATED BLOOD LOSS (EBL) WAS STATED TO BE SIGNIFICANTLY HIGHER IN THE MP GROUP (P .001), WITH A MEDIAN EBL OF 150ML VS SP OF 100ML. POSTOPERATIVELY, THE SP APPROACH REQUIRED A SIGNIFICANTLY SHORTER TIME OF HOSPITAL STAY (P .001), WITH A MEDIAN OF 17.7 HOURS VS 33 HOURS IN THE MP GROUP. A TOTAL OF 78 OF 99 (78.7%) PLANNED OUTPATIENT CASES OF THE SP GROUP WERE DISCHARGED WITHIN THE FIRST 8 HOURS AFTER SURGERY. WITHIN THE FIRST 30 DAYS POSTOPERATIVELY, COMPLICATIONS WERE SEEN IN 18.8% AND 7.6% OF MP AND SP PATIENTS, RESPECTIVELY. THE MOST COMMON MILD COMPLICATIONS WERE URINARY TRACT INFECTIONS AND HEMATURIA IN BOTH GROUPS. SEVERE COMPLICATIONS (CLAVIEN-DINDO =III) WERE SEEN IN 2.4% OF MP AND 0.6% OF SP PATIENTS, WITH NO SIGNIFICANT DIFFERENCE BETWEEN GROUPS. DURING THIS PERIOD OF TIME, THE READMISSION RATE FOR MP (10.8%) WAS SIGNIFICANTLY HIGHER THAN FOR SP (0%) (P .001). THERE WERE NO SPECIFIC DETAILS FOR ANY OF THE COMPLICATIONS OR REASONS FOR READMISSION NOTED IN TABLE 2. MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR WERE MADE; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }