{ "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": "2955842-2023-15442", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230601", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20210319", "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": "CH", "manufacturer_contact_area_code": "408", "date_added": "20230601", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1130675", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230601", "brand_name": "DA VINCI S", "generic_name": "PATIENT SIDE 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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380429-03", "catalog_number": "380429", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210617", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874113011", "udi_public": "(01)00886874113011", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250724", "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": "20230601", "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": "20210319", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17039787", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210319", "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": "316387166", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS REPRODUCED DURING FIELD EVALUATION. THE FSE REVIEWED THE LOG AND FOUND ERRORS 23002 AND 23008 POINTING TO THE RIGHT MTM, AXIS 8. THE FSE TRIED TO CALIBRATE THE MTM, AND CALIBRATION PASSED, BUT THE ERROR PERSISTED. THE MTM ENCODER WAS SUSPECTED TO BE DEFECTIVE. THE FSE REPLACED THE MTM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE RIGHT MTM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED THE REPORTED EVENT. ERROR 230 OCCURRED WHEN HOMING THE UNIT IN NORMAL MODE. THE UNIT ALSO FAILED THE GRIP CHECK SENSOR TEST. THE GRIP LEVERS AND FLEX CIRCUIT ASSEMBLY WILL BE REPLACED AS A FIX FOR THE FIELD REPORTED ERROR." }, { "mdr_text_key": "316387167", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL ESOPHAGECTOMY SURGICAL PROCEDURE, ERROR 23002 OCCURRED. THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) OF THE EVENT, AND THE TSE TRIED TO COLLECT MORE INFORMATION TO PROVIDE TROUBLESHOOTING ASSISTANCE, BUT THE NURSE STATED SHE WAS BUSY AND STATED HAD ALREADY PROVIDED THE INFORMATION TO THE FIELD SERVICE ENGINEER (FSE). THERE WAS NO REPORTED INJURY. IT WAS FURTHER REPORTED THAT ERROR 23002 OCCURRED MANY TIMES DURING THE PROCEDURE. THE ERROR WAS POINTING TO THE RIGHT MASTER TOOL MANIPULATOR (MTM). THE CUSTOMER HAD REBOOTED THE SYSTEM WITH NO RESOLVE. THE FSE SUGGESTED TO RECOVER THE FAULT AND REBOOT THE SYSTEM, BUT THE CUSTOMER STATED THAT THEY REBOOTED THE SYSTEM AND THE ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY WITH NO REPORTED INJURY. THE SYSTEM WAS IN USE FOR 30 MINUTES BEFORE THE PROCEDURE WAS CONVERTED. THE FSE INDICATED THAT FULL TROUBLESHOOTING WAS NOT EXHAUSTED TO ADDRESS THE REPORTED ISSUE PRIOR TO THE CONVERSION. ON 12-APRIL-2021, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE FSE: THE REPORTED ISSUE WAS CALLED IN BY THE NURSE. THE NURSE STATED THAT THE TRIED TO REBOOT THE SYSTEM BEFORE CONTACTING FOR TROUBLESHOOTING ASSISTANCE, BUT THE ERROR PERSISTED FREQUENTLY. THE FSE REQUESTED THE NURSE TO REVIEW THE POPUP LOG TO DETERMINE THE CAUSE OF THE ERROR, BUT THE NURSE STATED SHE WAS NOT ABLE TO TROUBLESHOOT DURING THE PROCEDURE AT THE TIME OF THE CALL. THE CUSTOMER REQUESTED THE FSE TO CHECK THE SYSTEM ON SITE. BY THE TIME THE FSE ARRIVED, THE PROCEDURE WAS ALREADY CONVERTED. THE FSE NOTED THAT NO ADDITIONAL RECOMMENDATION WAS REQUIRED BY THE USER BEFORE CONVERSION." } ], "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": "" } ] }