{ "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": "2955842-2021-11769", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20211217", "manufacturer_address_2": "", "pma_pmn_number": "UNKNOWN", "date_of_event": "20210604", "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", "Foreign", "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "JA", "manufacturer_contact_area_code": "408", "date_added": "20211217", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1929020", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20211217", "brand_name": "DA VINCI", "generic_name": "DA VINCI SURGICAL 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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "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": "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20211217", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "81 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Obstruction/Occlusion", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available", "Obstruction/Occlusion", "Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available" ] } ], "distributor_city": "", "date_report": "20211122", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13029602", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20211122", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "287345676", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 22-NOV-2021, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A INTERNATIONAL JOURNAL OF UROLOGY CASE REPORTS ARTICLE TITLED, ¿ENDOSCOPIC LASER TREATMENT FOR URINE LEAKAGE CAUSED BY AN ISOLATED CALYX AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY¿ (INOUE, R., ISOYAMA, N., ET AL., 2021). WITHIN THE JOURNAL ARTICLE, A POST-OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED: \"AN (B)(6) MAN UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY FOR THE TREATMENT OF RENAL CELL CARCINOMA (CT1BN0M0). POSTOPERATIVELY, URINE LEAKAGE WAS OBSERVED AND DID NOT IMPROVE WITH CONSERVATIVE MEASURES. RETROGRADE PYELOGRAPHY AND COMPUTED TOMOGRAPHY REVEALED THAT URINE LEAKAGE ORIGINATED FROM THE ISOLATED CALYX CAUSED BY INFUNDIBULAR STENOSIS. ENDOSCOPIC TREATMENT VIA THE TRANSURETHRAL APPROACH WAS SELECTED TO PRESERVE RENAL FUNCTION. URETEROSCOPY SHOWED THAT THE UPPER CALYX WAS COMPLETELY OBSTRUCTED BY THE SUTURES. THEREFORE, WE CUT THE SUTURE THREAD USING LASER, AND A URETERAL STENT WAS PLACED IN THE UPPER RENAL CALYX. FLUID DRAINAGE IMMEDIATELY DISAPPEARED AFTER THE PROCEDURE, AND THE PATIENT DID NOT LOSE RENAL FUNCTION.\" ISI HAS REACHED OUT TO THE AUTHOR TO OBTAIN ADDITIONAL INFORMATION BUT HAS NOT YET RECEIVED A RESPONSE." }, { "mdr_text_key": "287345677", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED POST-OPERATIVE COMPLICATIONS CANNOT BE DETERMINED OR IS UNKNOWN. THERE IS NO ALLEGATION OF A DA VINCI PRODUCT MALFUNCTION. AS A RESULT, NO PRODUCTS ARE EXPECTED FOR RETURN AND ANALYSIS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SITE HISTORY COMPLAINT REVIEW WAS UNABLE TO BE CONDUCTED AT THIS TIME DUE TO LACK OF INSTRUMENT DETAIL AND LACK OF SPECIFIC EVENT/PROCEDURE DETAIL. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM OR INSTRUMENT LOG REVIEWS COULD NOT BE PERFORMED DUE TO LACK OF SYSTEM, PROCEDURE, AND INSTRUMENT DETAIL. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS REPORTABLE DUE TO THE FOLLOWING: WITHIN THE JOURNAL ARTICLE TITLED, ¿ENDOSCOPIC LASER TREATMENT FOR URINE LEAKAGE CAUSED BY AN ISOLATED CALYX AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY,¿ IT IS NOTED THAT A PATIENT EXPERIENCED POST-OPERATIVE URINE LEAKAGE WHICH REQUIRED ADDITIONAL MEDICAL INTERVENTION. THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED." } ], "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": "" } ] }