{ "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": "2955842-2023-17048", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230713", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20191217", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230714", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "699390", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230713", "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", "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": "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": [ "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": "", "date_changed": "20250805", "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": "20230713", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pulmonary Embolism", "Abscess", "Hematoma", "Pulmonary Embolism", "Abscess", "Hematoma" ] } ], "distributor_city": "", "date_report": "20230615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17322319", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230615", "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": "319096195", "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, ¿EXTRAPERITONEAL VERSUS TRANSPERITONEAL SINGLE-PORT ROBOTIC RADICAL PROSTATECTOMY: A COMPARATIVE ANALYSIS OF PERIOPERATIVE OUTCOMES\", THE FOLLOWING EVENTS WERE REPORTED. 98 PATIENTS UNDERWENT SINGLE-PORT ROBOTIC PROSTATECTOMY USING THE DA VINCI SP ROBOTIC SYSTEM WITH EXTRAPERITONEAL (GROUP I (N=52)) VERSUS TRANSPERITONEAL (GROUP II (N=46)) APPROACH FROM SEPTEMBER 2018 TO JUNE 2019 WERE INCLUDED IN THE STUDY. THE MEAN OPERATIVE TIME WAS SIGNIFICANTLY SHORTER WITH THE EXTRAPERITONEAL APPROACH COMPARED TO THE TRANSPERITONEAL APPROACH (201± 37.5 VERSUS 248.2 ± 42.3 MIN). NO PATIENTS RECEIVED PERIOPERATIVE BLOOD TRANSFUSION AND THE ESTIMATED BLOOD LOSS WERE SIMILAR AS 145.7± 87.7 VERSUS 117.6± 93.7ML RESPECTIVELY. POSTOPERATIVE COMPLICATIONS WERE COMPARABLE BETWEEN THE TWO GROUPS (TABLE 1). THERE WAS A TOTAL OF 6 CASES THAT DEVELOPED GRADE II CLAVIEN-DINDO COMPLICATIONS WHICH INCLUDES URINARY TRACT INFECTION, ACUTE KIDNEY INJURY, PULMONARY EMBOLISM. THERE WERE A TOTAL OF 7 CASES THAT DEVELOPED GRADE IIIA CLAVIEN-DINDO COMPLICATIONS, WHICH INCLUDES LYMPHOCELE, PELVIC ABSCESS, PELVIC HEMATOMA, URINE LEAKAGE. THE PATIENTS WITH PELVIC LYMPHOCELE, ABSCESS, HEMATOMA WERE MANAGED WITH PERCUTANEOUS DRAINAGE. THERE WAS NO MENTION OF MALFUNCTIONS OF ANY DA VINCI SYSTEMS, INSTRUMENTS OR ACCESSORIES IN THE ARTICLE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, AT THE TIME OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED." }, { "mdr_text_key": "319096196", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT DAVINCI PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENTS. THEREFORE, NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION AND THE ROOT CAUSE OF THE CUSTOMER REPORTED POSTOPERATIVE INCIDENTS CANNOT BE DETERMINED. ARTICLE CITATION: KAOUK J, AMINSHARIFI A, WILSON CA, SAWCZYN G, GARISTO J, FRANCAVILLA S, ABERN M, CRIVELLARO S. EXTRAPERITONEAL VERSUS TRANSPERITONEAL SINGLE PORT ROBOTIC RADICAL PROSTATECTOMY: A COMPARATIVE ANALYSIS OF PERIOPERATIVE OUTCOMES. J UROL. 2020 JUN;203(6):1135-1140. AVAILABLE AT : DOI: 10.1097/JU.0000000000000700. EPUB 2019 DEC 17." } ], "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": "" } ] }