{ "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": "2955842-2022-13109", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220722", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20220622", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20220723", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190531", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "116609", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220722", "brand_name": "DA VINCI XI", "generic_name": "SURGEON SIDE CONSOLE, RECONDITIONED", "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": "380723-06", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220711", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "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": [ "No Display/Image", "No Display/Image" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250730", "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": "20220722", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20220622", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15090124", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220622", "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": "296463414", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE HRSV MONITOR UNIT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION AND THE FAILURE ANALYSIS TESTING HAS BEEN COMPLETED. THE MONITOR WAS INSTALLED AND TESTED IN THE TEST SYSTEM AND THE SYSTEM STARTED UP WITH NO VIDEO IN THE RIGHT EYE. THE REPORTED FAILURE WAS CONFIRMED/REPLICATED. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO OPEN SURGERY AFTER THE START OF THE PROCEDURE DUE TO THE HRSV ISSUE IDENTIFIED DURING THE PROCEDURE. FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE." }, { "mdr_text_key": "296463415", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH OTHER URINARY DIVERSION SURGICAL PROCEDURE, THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLACK. THE RIGHT AND LEFT IMAGES WORKED FINE IN THE VISION SIDE CART (VSC). THE BLUE FIBER CABLE WAS PROPERLY CONNECTED TO THE SSC AND THE LED WAS BLUE. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO EMERGENCY POWER OFF (EPO) THE SSC AND VISION SIDE CART (VSC), BUT THE RIGHT MONITOR REMAINED COMPLETELY BLACK. THE SURGEON WAS UNDECIDED TO AS TO WHETHER TO CONVERT OR ABORT THE PROCEDURE AT THAT TIME. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS A ONE HOUR DELAY AS THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. THE ISSUE DID NOT OCCUR DURING A CRITICAL STEP. IT IS UNKNOWN IF SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM WAS ONLY ABLE TO SEE THROUGH ONE EYE OF THE HRSV." } ], "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": "" } ] }