{ "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": "2955842-2026-29251", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260701", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20250531", "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": "", "manufacturer_contact_area_code": "", "date_added": "20260701", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "652476", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260701", "brand_name": "DA VINCI SYSTEM", "generic_name": "DA VINCI SYSTEM", "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": "UNKNOWN", "catalog_number": "UNKNOWN", "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" ], "reporter_state_code": "IL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260701", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death", " R", " L" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Sepsis", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260605", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25685142", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260605", "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": "406236912", "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. NO IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE REVIEWED. SECTION A3A- PATIENT GENDER REPRESENTS THE MAJORITY OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON A UNSPECIFIED DAVINCI DEVICE. A GENERIC MATERIAL NUMBER IS USED AS THE PRIMARY PRODUCT. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON BOTH DA VINCI XI AND SI SYSTEMS. SECTION E - THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT. CITATION (APA): VALENZI, F. M., SANTARELLI, V., AVESANI, G., ALJOULANI, M., HABERAL, H. B., ANGUIANO, J. R. T., MORGANTINI, L. A., CALVO, R. S., BIASATTI, A., FUSCHI, A., PASTORE, A. L., & CRIVELLARO, S. (2025). SINGLE-PORT VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY IN ELDERLY PATIENTS. CANCERS, 17(11), 1857. HTTPS://DOI.ORG/10.3390/CANCERS17111857." }, { "mdr_text_key": "406236913", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "A REVIEW OF AN ARTICLE THAT EVALUATED THE COMPARISON OF SINGLE-PORT VERSUS MULTI-PORT ROBOTIC RADICAL PROSTATECTOMY IN ELDERLY PATIENTS, FOCUSING ON PERIOPERATIVE OUTCOMES AND POSTOPERATIVE COMPLICATIONS WAS PERFORMED. THE STUDY RETROSPECTIVELY ANALYZED 338 PATIENTS UNDERGOING ROBOT-ASSISTED RADICAL PROSTATECTOMY (SINGLE-PORT (SP-RARP)OR MULTI-PORT (MP-RARP) BETWEEN JANUARY 2018 AND DECEMBER 2023. ONE RECTAL INJURY OCCURRED IN THE MP GROUP, WHILE THE SP GROUP HAD TWO EVENTS (RECTAL AND BLADDER INJURY). IN ELDERLY PATIENTS, THE MP GROUP HAD TWO COMPLICATIONS (RECTAL INJURY AND CONVERSION TO OPEN SURGERY DUE TO HEMODYNAMIC INSTABILITY), WHEREAS THE SP GROUP HAD SIX COMPLICATIONS (RECTAL INJURY, BLADDER INJURY, OBTURATOR NERVE INJURY, AND PERSISTENT PNEUMOPERITONEUM); ALL WERE MANAGED INTRAOPERATIVELY. POSTOPERATIVE CLAVIEN¿DINDO GRADE 3 COMPLICATIONS INCLUDED PARALYTIC ILEUS AND LYMPHOCELES REQUIRING DRAINAGE IN THE MP GROUP AND LYMPHOCELES IN THE SP GROUP. ONE PATIENT IN THE MP GROUP DIED DUE TO POSTOPERATIVE UROSEPSIS (CLAVIEN¿DINDO GRADE 5); HOWEVER, THE REPORT DOES NOT CLEARLY DESCRIBE THE CLINICAL SEQUENCE OR ESTABLISH WHETHER THIS OUTCOME WAS DIRECTLY ATTRIBUTABLE TO A SPECIFIC POSTOPERATIVE COMPLICATION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }