{ "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": "2955842-2025-02243", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250305", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250204", "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": "408", "date_added": "20250305", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200917", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1458585", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250305", "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": "380941-40", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "04/03/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250826", "health_professional": "Y", "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": "20250305", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250204", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21524982", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250204", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "364999038", "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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS NOT CONFIRMED. THE FSE REVIEWED THE SYSTEM LOGS FROM THE DAY PRIOR AND FOUND A LOT OF POWER SUPPLY RELATED ERRORS, BUT THE SYSTEM DID NOT PRODUCE THE SAME PATTERN DURING THE VISIT. THE FSE FOUND THE SYSTEM IN PROPER WORKING ORDER. THE ISSUE WAS CONSIDERED RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FSE'S FIELD EVALUATION. THE FSE WENT ON SITE AND WAS NOT ABLE TO REPRODUCE THE ISSUE. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE." }, { "mdr_text_key": "364999039", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A REPEATED NON-RECOVERABLE ERROR OCCURRED. THE SITE RECEIVED PHONE ASSISTANCE FROM AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE). THE SITE POWER CYCLED THE SYSTEM, BUT THE ERROR WAS NOT RESOLVED. THE TSE HAD THE SITE PERFORM A HARD POWER CYCLE OF THE SYSTEM, BUT A SYSTEM MESSAGE APPEARED STATING THAT THE PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY. THE TSE HAD THE SITE MOVE THE POWER CORDS AND VERIFY POWER. THE SITE CONFIRMED THAT THE OUTLET HAD POWER AND MOVED THE POWER CORD AGAIN; HOWEVER, ANOTHER ERROR APPEARED AFTER THAT. THE SURGEON CONVERTED TO LAPAROSCOPIC SURGERY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORT WAS PLACED ON THE PATIENT WHEN THE ISSUE WAS IDENTIFIED. SINCE THE PROCEDURE WAS A SINGLE PORT, THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION, AND ADDITIONAL PORTS WERE ADDED." }, { "mdr_text_key": "368970216", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED BASED ON FURTHER INVESTIGATION: THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONFIRMED THE PATIENT SIDE CART WAS CONNECTED TO AC POWER AND THE LED'S INDICATED THE BATTERY WAS CHARGING. THE FSE REVIEWED THE ERROR LOGS AND CONFIRMED THE ISSUE IN THE LOGS FROM THE PREVIOUS DAY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE FSE FOLLOWED UP WITH THE ROBOTICS COORDINATOR WHO MENTIONED THAT THE STAFF HAD BEEN UNPLUGGING THE ROBOT CARTS OVER THE WEEKEND TO CONSERVE ENERGY. THE ROBOTICS COORDINATOR WAS AWARE AND PASSED ALONG THE MESSAGE TO STAFF THAT THE PATIENT CART MUST REMAIN PLUGGED IN TO THE WALL. A REVIEW OF THE SITE¿S SYSTEM LOGS CONFIRMED THE POWER RELATED ERRORS." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/25/2025" } ] }