{ "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": "2955842-2022-12332", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220623", "manufacturer_address_2": "", "pma_pmn_number": "N/A", "date_of_event": "20210325", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20220623", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "307772", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220623", "brand_name": "DA VINCI", "generic_name": "DA VINCI XI 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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "health_professional": "", "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": "20220623", "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": "White", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding", "Pseudoaneurysm", "Hemorrhage/Blood Loss/Bleeding", "Pseudoaneurysm" ] } ], "distributor_city": "", "date_report": "20210330", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "14787428", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210330", "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": "294600708", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT AFTER A PROSPECTIVE IRIS STUDY ROBOTIC PARTIAL NEPHRECTOMY ON (B)(6) 2021, THE PATIENT PRESENTED WITH PRE-SYNCOPAL SYMPTOMS ON (B)(6) 2021. THE PATIENT¿S ¿HEMATOCRIT (HCT) DROPPED FROM 41 TO 25, COMPUTED TOMOGRAPHY (CT) A/P¿ INDICATING A CONCERN FOR BLEEDING AT THE SURGICAL SITE. THE PATIENT UNDERWENT ¿IR COIL EMBOLIZATION OF THE RIGHT RENAL ARTERY PSEUDOANEURYSM¿ (B)(6) 2021 AND TOLERATED THE PROCEDURE WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS ADMITTED TO THE HOSPITAL THEN DISCHARGED ON (B)(6) 2021. ON (B)(6) 2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: IT WAS CONFIRMED THAT THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS AND NO ISSUES WITH IRIS MEDICAL IMAGING. DUE TO THE POST-PROCEDURE COMPLICATIONS, THE PATIENT WAS ADMINISTERED AN UNSPECIFIED AMOUNT OF BLOOD BY TRANSFUSION. IT WAS CONFIRMED THAT THE SURGEON VERBALLY STATED, AND DOCUMENTED IN THE ELECTRONIC DOCUMENTATION (EDC), THAT THERE IS NO ALLEGATION OF A MALFUNCTION OF A DA VINCI PRODUCT AND NO ALLEGED CAUSAL RELATIONSHIP BETWEEN THE IRIS STUDY AND THE PATIENT¿S POST-OPERATIVE BLEEDING COMPLICATION AND SUBSEQUENT BLOOD TRANSFUSION AND RADIOLOGICAL INTERVENTION. THE OBSERVED EVENT WAS DOCUMENTED AS NOT RELATED TO THE DEVICE. ADDITIONALLY, THE SURGEON REPORTED THAT ¿THE APP WAS NOT INVOLVED.¿" }, { "mdr_text_key": "294600709", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF THE IRIS SERVICE OCCURRING. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. IRIS IS A SERVICE TO CREATE A 3D RENDERING OF THE KIDNEY. THEREFORE, SYSTEM/INSTRUMENT LOG REVIEW IS NOT APPLICABLE AS THE IRIS PRODUCT DOES NOT HAVE ANY LOGS. THERE IS NO PRODUCT SERIAL NUMBER AS IT IS A DIGITAL PRODUCT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL DEVELOPMENT ENGINEER (CDE) CONDUCTED A CLINICAL REVIEW OF THIS EVENT AND FOUND THAT THE FOLLOWING APPLIES FOR THIS EVENT AS THE COMPLICATIONS OF PARTIAL NEPHRECTOMY PROCEDURES ARE WELL-KNOWN: RENAL ARTERY PSEUDOANEURYSMS OCCUR IN 1-2% OF PARTIAL NEPHRECTOMIES WHEN IMAGED POST-OPERATIVELY AND ARE A KNOWN, BUT INFREQUENT, COMPLICATION WITH OPERATIVE APPROACHES. THERE IS SOME DATA TO SUGGEST THAT MINIMALLY INVASIVE SURGERY (MIS) APPROACHES (LAP AND ROBOT) MAY HAVE A SLIGHTLY HIGHER INCIDENCE. THE MECHANISM IS POSTULATED TO BE THE SUTURE CLOSURE OF THE RENAL PARENCHYMA AFTER THE EXCISION OF THE LESION WITH THE NEEDLE CAUSING ARTERIAL DAMAGE LEADING TO THE FORMATION OF THE PSEUDOANEURYSMS. THESE CAN BE SERIOUS COMPLICATIONS REQUIRING FURTHER TREATMENT WITH EMOBILIZATION OR SURGERY OR, WHEN LESS SERIOUS, CAN BE OBSERVED. THE REPORTED EVENT DOES NOT APPEAR TO BE RELATED TO THE USE OF IRIS. IRIS IS DESIGNED FOR USE BY HEALTH CARE PROFESSIONALS AND IS INTENDED TO ASSIST THE CLINICIAN WHO IS RESPONSIBLE FOR MAKING ALL FINAL PATIENT MANAGEMENT DECISIONS. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A PROSPECTIVE IRIS STUDY ROBOTIC PARTIAL NEPHRECTOMY ON (B)(6) 2021, THE PATIENT PRESENTED WITH PRE-SYNCOPAL SYMPTOMS ON (B)(6) 2021 AND THE PATIENT¿S ¿HCT DROPPED FROM 41 TO 25, CT A/P¿ INDICATING A CONCERN FOR BLEEDING AT THE SURGICAL SITE. DUE TO THE POST-PROCEDURE COMPLICATIONS, THE PATIENT RECEIVED AN UNSPECIFIED AMOUNT OF BLOOD BY TRANSFUSION AND UNDERWENT RADIOLOGICAL INTERVENTION OF ¿IR COIL EMBOLIZATION OF THE RIGHT RENAL ARTERY PSEUDOANEURYSM¿ ON (B)(6) 2021. ADDITIONALLY, THE SURGEON REPORTED THAT ¿THE APP WAS NOT INVOLVED.¿ THE PATIENT TOLERATED THE FOLLOW-UP PROCEDURE WELL WITH NO IMMEDIATE COMPLICATIONS. THE PATIENT WAS DISCHARGED ON (B)(6) 2021." } ], "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": "" } ] }