{ "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": "2955842-2025-31450", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250728", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20250703", "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": "20250728", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220609", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1440873", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250728", "brand_name": "DA VINCI SP", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380601-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250716", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114605", "udi_public": "(01)00886874114605", "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": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/28/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250811", "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": "20250728", "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": "20250703", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22630183", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250703", "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": "376075606", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE REPLACED PSM #2 TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS THEN TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE PSM FOR FAILURE ANALYSIS EVALUATION. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE PSM HAS NOT BEEN COMPLETED." }, { "mdr_text_key": "376075607", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT A NON-RECOVERABLE FAULT OCCURRED. THE CUSTOMER POWER-CYCLED THE SYSTEM MULTIPLE TIMES; HOWEVER, THE ERROR RETURNED. THE CUSTOMER UNDOCKED AND POWER CYCLED THE SYSTEM AGAIN. THE ERROR RETURNED. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER TO HARD POWER CYCLE THE SYSTEM AND PERFORM AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC). THE SYSTEM POWERED UP AND AN ERROR AGAINST PATIENT SIDE MANIPULATOR (PSM) #2 WAS PRESENT. THE TSE HAD THE CALLER PERFORM A HARD POWER CYCLE AND PERFORM AN EPO AGAIN, KEEPING THE SYSTEM OFF LONGER. THE ERROR(S) RETURNED. THE TSE ADVISED TO CONTINUE TO PERFORM HARD CYCLES TO SEE IF THE ERROR WOULD CLEAR, AND ALSO ADVISED THAT THE ERRORS COULD RETURN. THE PROCEDURE WAS ULTIMATELY ABORTED AFTER ANESTHESIA HAD BEEN ADMINISTERED TO THE PATIENT AND PORTS HAD BEEN PLACED." }, { "mdr_text_key": "377119992", "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 PATIENT SIDE MANIPULATOR (PSM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE SYSTEM LOGS, ERROR NODE NOT PRESENT AND CURRENT VOLTAGE MONITOR ERRORS WERE SEEN POINTING TO THE SURGICAL AXIS BRUSHLESS MOTOR CONTROLLER (SAC) NODE. MULTIPLE COMMUNICATION ERRORS WERE ALSO SEEN. DURING VISUAL INSPECTION, THE INSERTION FLAT FLEX CABLES WERE TORN AND THE PROXIMAL BELT WAS BROKEN. THE PSM WAS PARTIALLY DISASSEMBLED TO INSPECT THE NINE AXIS DRIVE (NAD) PCA AND A PIECE OF THE BELT WAS SEEN STUCK BETWEEN THE DISCRETE BRUSHLESS MOTOR AMPLIFIER (DBMA) PCAS." }, { "mdr_text_key": "377119993", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "08/08/2025" } ] }