{ "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": "2955842-2025-00306", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250113", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20241215", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250114", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231218", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1551276", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250113", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "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": "480275-08", "catalog_number": "480275", "lot_number": "L80231218 0095", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(10)L80231218", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/30/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20250113", "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": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20241219", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21145974", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241219", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "361234727", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE BLADE OF A HARMONIC ACE INSTRUMENT FRACTURED WHEN THE SURGEON ACTIVATED THE INSTRUMENT. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT THE SURGEON INDICATED THAT HE DID NOT TOUCH ANYTHING HARD WITH THE INSTRUMENT BEFORE OR WHEN THE EVENT OCCURRED. THE CUSTOMER REMOVED THE FRACTURED PIECE OF THE BLADE FROM THE PATIENT DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGICAL TASK BEING PERFORMED AT THE TIME OF THE DEVICE BREAKAGE WAS DISSECTION AND THE INSTRUMENT WAS IN USE FOR ABOUT HALF AN HOUR BEFORE THE EVENT OCCURRED. THE SURGEON DID NOT NOTICE ANY ISSUE WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO BREAKAGE WITH THE INSTRUMENT'S WRIST STRAIGHTENED. THERE WAS NO RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS AGAIN STRAIGHTENED, AND THE SURGICAL STAFF DID NOT NOTICE ANY ADDITIONAL DAMAGE TO THE INSTRUMENT OR CANNULA. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE REMOVED BY THE FIRST ASSISTANT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENTS. THERE WERE NO POST-OPERATIVE TESTS LIKE X-RAYS OR ULTRASOUNDS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND THE FRAGMENT ARE AVAILABLE FOR ISI EVALUATION. THERE ARE NO IMAGES OF THE DEVICE OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE." }, { "mdr_text_key": "361234728", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "363971059", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CURVED BLADE. A PIECE APPROXIMATELY 0.313\" X 0.084\" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. IMAGE(S) AND/OR VIDEO CLIP(S) ASSOCIATED WITH THIS REPORTED EVENT WERE NOT SUBMITTED FOR REVIEW. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DAMAGE DURING USE WHILE THE INSTRUMENT IS ACTIVATED. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. BLADE FRACTURES PROPAGATE FROM INITIAL CONTACT SITES DUE TO THE ULTRASONIC VIBRATION OF THE HARMONIC ACE BLADE LEADING TO EVENTUAL/PREMATURE FAILURE." }, { "mdr_text_key": "363971060", "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": "02/19/2025" } ] }