{ "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": "2955842-2023-14566", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20230525", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230501", "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": "20230525", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20210602", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1584416", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230525", "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": "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": "00886874114605", "udi_public": "(01)00886874114605", "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": "20250724", "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": "20230525", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20230501", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17002901", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230501", "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": "316000740", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE MENTIONED COMPLICATIONS CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: INTUITIVE SURGICAL. INC. BECAME AWARE OF A SURGICAL TECHNIQUES IN UROLOGY ARTICLE, AND IT MENTIONED ONE POST-OPERATIVE COMPLICATION REQUIRING READMISSION, WHICH WAS A PELVIC DRAIN PLACEMENT FOR ANASTOMOTIC LEAK AFTER SP TRANSVESICAL RADICAL PROSTATECTOMY (CLAVIEN-DINDO 3A) THAT RESOLVED BY TEMPORARY DRAIN PLACEMENT. THERE WAS NO MENTION OF MALFUNCTIONS OF ISI INSTRUMENTS, SYSTEMS OR ACCESSORIES IN THE ARTICLE." }, { "mdr_text_key": "316000741", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 01-MAY-2023, INTUITIVE SURGICAL BECAME AWARE OF A SURGICAL TECHNIQUES IN UROLOGY ARTICLE TITLED, ¿TRANSVESICAL PERCUTANEOUS ACCESS ALLOWS FOR EPIDURAL ANESTHESIA WITHOUT MECHANICAL VENTILATION IN SINGLE-PORT ROBOTIC RADICAL AND SIMPLE PROSTATECTOMY¿ (KAOUK, J., ET AL., 2023). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. A TOTAL OF 12 PATIENTS WERE SELECTED TO UNDERGO EPIDURAL PLACEMENT PRIOR TO SINGLE PORT TRANSVESICAL SIMPLE PROSTATECTOMY OR RADICAL PROSTATECTOMY FROM JULY 2022 TO OCTOBER 2022. ALL CASES WERE COMPLETED WITHOUT EXTRA PORTS, OPEN CONVERSION OR CONVERSION TO GENERAL ANESTHESIA. NO ANESTHETIC COMPLICATIONS WERE NOTED. NO PATIENTS REQUIRED OPIOID PAIN MEDICATIONS AFTER DISCHARGE AND ALL PATIENTS WITH AN OUTPATIENT ENCOUNTER WERE DISCHARGED ON THE SAME DAY OF THE PROCEDURE. ONE PATIENT WAS A PRE-PLANNED ADMISSION GIVEN UNDERLYING COMORBIDITES AND WAS OBSERVED POSTOPERATIVELY WITHOUT COMPLICATIONS. THERE WAS ONE POST-OPERATIVE COMPLICATION REQUIRING READMISSION, WHICH WAS A PELVIC DRAIN PLACEMENT FOR ANASTOMOTIC LEAK AFTER SP TRANSVESICAL RADICAL PROSTATECTOMY (CLAVIEN-DINDO 3A)AND RESOLVED BY TEMPORARY DRAIN PLACEMENT. THERE WAS NO MENTION OF MALFUNCTIONS OF ISI INSTRUMENTS, SYSTEMS OR ACCESSORIES IN THE ARTICLE. ACCORDING TO THE ARTICLE AUTHOR, THE POST-OPERATIVE COMPLICATION WAS AN EXPECTED POSSIBLE ADVERSE OUTCOMES AND THERE WAS NO DEVIATION FROM STANDARD OF CARE." } ], "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": "" } ] }