{ "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": "2955842-2026-03233", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260211", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20260114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260211", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190905", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "380018", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260211", "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": "380941-34", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260122", "device_report_product_code": "NAY", "device_age_text": "DA", "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": [ "Output Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/18/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "", "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": "20260211", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20260314", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24312806", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260114", "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": "392674915", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ASSISTED RADICAL EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER TRIED 4-5 TIPS AND SHEATHS BUT THE CORD LIGHT ON THE EMBEDDED SERIALIZER FOR MASTER (ESM) WAS AMBER, AND THEY WERE RECEIVING A MESSAGE TO REMOVE THE TIP AND INSTALL A NEW SHEATH. PRIOR TO CALLING, THE CUSTOMER HAD REPLACED THE TIP AND INSTRUMENT ON THE MONOPOLAR CURVED SCISSORS (MCS) MULTIPLE TIMES AND TRIED FIVE DIFFERENT INSTRUMENTS, WITH NO CHANGE. THE CUSTOMER NOTED THAT THEY HAD USED THE INSTRUMENT IN DIFFERENT DRIVES, ALSO WITH NO CHANGE, BUT HAD NOT REPLACED THE CORD. THE TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED THEY REPLACE THE MONOPOLAR ENERGY CORD WHICH THE USER PERFORMED WITH NO CHANGE. THE USER THEN POWERED OFF THE ERBE GENERATOR AND ENERGY SHIELD MONITOR (ESM) AND THE SYSTEM FAULTED AND THE CALLER POWER CYCLED THE SYSTEM TO RESTORE ESM FUNCTIONALITY. THE TSE WALKED THE CALLER THROUGH RESEATING THE GROUND CONNECTOR AND GREEN MONOPOLAR CABLE CONNECTOR TO ANOTHER MONOPOLAR RECEPTACLE ON THE FRONT OF THE ERBE WITH NO CHANGE. THE CALLER THEN USED A 3RD MONOPOLAR GREEN/GRAY ENERGY CABLE FROM THE ESM TO THE INSTRUMENT WITH NO CHANGE. THE CUSTOMER THEN CONVERTED FROM SINGLE PORT (SP) TO MULTI-PORT XI." }, { "mdr_text_key": "392674916", "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 SYSTEM DISPLAYED AN INSULATION ERROR MESSAGE. THE FSE WENT ON SITE AND IDENTIFIED RESIDUE ON THE CORDS FOR THE EXISTING ENERGY SHIELD MONITOR (ESM). THERE WAS ALSO RESIDUE ON THE CORNERS OF THE ERBE SCREEN, POSSIBLY DUE TO A BAD PART OR STAFF WAS UTILIZING A CORROSIVE WIPE FOR CLEANING. THE FSE REPLACED THE ESM TO RESOLVE THE ISSUE WITH THE RE-OCCURRING INSULATION ERROR MESSAGE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS STILL PENDING. ." }, { "mdr_text_key": "395670794", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "395670795", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED ENERGY SHIELD MONITOR (ESM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE LOGS, ERRORS WERE FOUND INDICATING THE ESM WAS NOT PRESENT, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A TEST SYSTEM AND FUNCTIONED AS EXPECTED." } ], "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": "03/14/2026" } ] }