{ "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": "2955842-2026-19186", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260330", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20251024", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260330", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230223", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "782475", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260330", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM 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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20251117", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Power Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260330", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "76 YR", "patient_sex": "Male", "patient_weight": "81 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260327", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24716660", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251024", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "397080757", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE ENERGY SHIELD MONITOR (ESM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE ESM PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ESM WAS FOUND WITH ERRORS INDICATING NODE NOT PRESENT, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE LEFT CONTROLLER AREA NETWORK (CAN) ELECTROSURGICAL UNIT (ESU) SCREW INSERT WAS FOUND DAMAGED. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. THE UNIT WAS LEFT TO IDLE FOR APPROXIMATELY 2 HOURS; HOWEVER, NO FAULTS OR ERRORS OCCURRED. ALL LEDS WERE OBSERVED ON AND FUNCTIONED AS EXPECTED." }, { "mdr_text_key": "397080758", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED LEFT NEPHROURETERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE ENERGY SHIELD MONITOR (ESM) WOULD NOT LIGHT UP AND A MESSAGE ON THE MONITOR INDICATED THAT THE ENERGY SHIELD COULD NOT BE DETECTED. THE TSE INSTRUCTED THE CUSTOMER TO CHECK ALL THE CABLES ON THE BACK OF THE ESM TO ENSURE THEY WERE FULLY SEATED, WHICH THEY WERE. THE CUSTOMER ALSO CHECKED THE CABLES ON THE OTHER END, WHICH WERE ALSO FULLY SEATED. THE CUSTOMER MENTIONED A SCREEN MESSAGE INDICATING THAT THE VIDEO PROCESSOR (VP) WAS NOT DETECTED. UPON CHECKING, THE GRAY FIBER WAS FOUND TO BE MISSING, SO THE CUSTOMER USED A FIBER FROM ANOTHER SYSTEM TO CONNECT THE VP TO THE CORE. THE TSE ALSO HAD THE CUSTOMER CHECK THE ROCKER SWITCH TO ENSURE IT WAS IN THE ON POSITION. A HARD POWER CYCLE OF THE SYSTEM WAS PERFORMED, BUT THE ESM STILL DID NOT LIGHT UP. THE ERBE WAS ON, WITH MONOPOLAR AND NEUTRAL PAD CONNECTIONS PLUGGED IN. THE CUSTOMER NOTED THAT ANOTHER SYSTEM HAD ISSUES WITH ARM 1 AND THAT TWO CASES WERE SCHEDULED FOR NEXT WEEK. THE CUSTOMER REQUESTED THAT THE FIELD SERVICE ENGINEER (FSE) REPAIR THE SYSTEMS BEFORE THE SCHEDULED CASES. NO LIVE LOGS WERE AVAILABLE DURING THE CALL. ISI FOLLOWED UP WITH THE NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE OCCURRED PRE-ANESTHESIA, BEFORE THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM (OR) AND NO PORTS WERE PLACED. THE PROCEDURE WAS A ROBOTIC ASSISTED LEFT NEPHROURETERECTOMY THAT WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC SURGERY WHICH REQUIRED THE PLACEMENT OF ADDITIONAL PORTS. THE PATIENT TOLERATED THE CHANGE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }