{ "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": "2955842-2024-20527", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20241016", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20240326", "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": "20241016", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2567378", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241016", "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": "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": "CA", "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": "20241016", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "61 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Obstruction/Occlusion", "Tissue Breakdown", "Unspecified Blood or Lymphatic problem", "Obstruction/Occlusion", "Tissue Breakdown", "Unspecified Blood or Lymphatic problem" ] } ], "distributor_city": "", "date_report": "20240920", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20463872", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240920", "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": "354365399", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. SPECIFIC DA VINCI SYSTEM AND EVENT DATE INFORMATION WERE NOT PROVIDED. CITATION: LAMA, D.J., THOMAS, K., VERNEZ, S.L. ET AL. MINIMALLY INVASIVE CYTOREDUCTIVE RADICAL PROSTATECTOMY, EXPLORING THE SAFETY AND FEASIBILITY OF A SINGLE-PORT OR MULTI-PORT ROBOTIC PLATFORM. BMC UROL 24, 72 (2024). HTTPS://DOI.ORG/10.1186/S12894-024-01463-2 SECTION A: PATIENT INFORMATION - NO SPECIFIC PATIENT DEMOGRAPHICS WERE PROVIDED FOR THE REPORTED PATIENTS. STUDY DEMOGRAPHICS CONSISTS OF PATIENTS WITH A MEDIAN AGE OF 61 YEARS OLD. SECTION D - SUSPECT MEDICAL DEVICE: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "354365400", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE CYTOREDUCTIVE PROSTATECTOMIES (CRP) OF SINGLE-PORT (SP) OR MULTI-PORT (MP) ROBOTIC SYSTEMS, AND THE FOLLOWING COMPLICATIONS WERE MENTIONED. TWENTY-FOUR PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CRP IN ONE SINGLE INSTITUTION BETWEEN 2015 TO 2022 WERE ENROLLED IN THE STUDY. OF THE 24 MEN WITH A MEDIAN PROSTATE SPECIFIC ANTIGEN (PSA) OF 32 NG/ML WHO UNDERWENT CRP, 17 (71%) WERE DONE USING THE MP ROBOTIC SYSTEMS AND 7 (29%) WERE USING THE SP SYSTEMS. THE OVERALL MAJOR COMPLICATION RATE WAS 8%. IN THE MULTI-PORT GROUP, ONE PATIENT DEVELOPED A SMALL BOWEL OBSTRUCTION REQUIRING SURGICAL DECOMPRESSION (GRADE III), AND ANOTHER EXPERIENCED A LYMPHOCELE THAT REQUIRED PERCUTANEOUS INTERVENTION (GRADE III). TWO PATIENTS IN THE MULTI-PORT GROUP WERE REPORTED AS EXPERIENCING AN ANASTOMOTIC LEAK, BUT NO MEDICAL INTERVENTION NOR THE SEVERITY WERE PROVIDED IN THE ARTICLE. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS REPORTED DURING THE ROBOTIC ASSISTED SURGERIES IN THE ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHORS, BUT NO RESPONSE HAS BEEN RECEIVED." } ], "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": "" } ] }