{ "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": "2955842-2025-48064", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251217", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251118", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20251217", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250612", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1612444", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251217", "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": "480275-10", "catalog_number": "480275", "lot_number": "K12250612 0084", "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(17)270630(10)K12250612", "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": "03/16/2026", "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": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20251217", "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": "20260407", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23828892", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251122", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "397815154", "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 BROKEN BLADE AT THE BASE OF THE BLADE. A PIECE APPROXIMATELY 9MM LONG WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE OF THE BLADE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE." }, { "mdr_text_key": "397815155", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "387884227", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PANCREATICODUODENECTOMY SURGICAL PROCEDURE, THE BLADE FRACTURED ON HARMONIC ACE WHEN THE SURGEON ACTIVATED THE INSTRUMENT, THE SURGEON CLAIMED THAT HE DIDN'T TOUCH ANYTHING HARD WITH THE INSTRUMENT. THE CUSTOMER TOOK OUT FRACTURED PIECE OF THE BLADE OUT OF THE PATIENT, IT WAS ONLY ONE PIECE, AND THE TEFLON HAD MELTED. THE INSTRUMENT WAS A SINGLE-USE INSTRUMENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE OR IRREGULARITIES WERE FOUND. THE INCIDENT OCCURRED DURING A CUTTING TASK, WHEN A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE SURGEON BELIEVES THE CAUSE OF THE INSTRUMENT BREAKAGE WAS POOR QUALITY. THE INSTRUMENT HAD BEEN IN USE FOR ABOUT HALF AN HOUR BEFORE THE ISSUE OCCURRED, WITH NO PRIOR SIGNS OF MALFUNCTION OR COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS. THE FRAGMENT DID NOT FALL DUE TO ANY ACCESSORY OR TIP COLLISION. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE, WITH THE WRIST STRAIGHTENED, AND THERE WAS NO RESISTANCE FELT DURING REMOVAL THROUGH THE CANNULA. NO DAMAGE TO THE CANNULA OR THE INSTRUMENT WAS NOTED AFTER THE EVENT. THE FRAGMENT WAS VISUALLY IDENTIFIED AND RETRIEVED, AND IT WAS CONFIRMED THAT ALL FRAGMENTS WERE ACCOUNTED FOR, AS THE SINGLE FRAGMENT WAS FOUND IN A PLASTIC GLOVE OUTSIDE THE PATIENT¿S BODY. NO ADDITIONAL SURGICAL PROCEDURES OR POSTOPERATIVE IMAGING WERE NECESSARY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT INJURY TO THE PATIENT, AND THERE WERE NO POST-SURGICAL COMPLICATIONS OR HOSPITAL READMISSIONS RELATED TO RETAINED FRAGMENTS. THE INSTRUMENT AND THE RETRIEVED FRAGMENT ARE AVAILABLE AND WILL BE RETURNED TO ISI FOR EVALUATION. NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE DEVICE OR PROCEDURE ARE AVAILABLE FOR ISI REVIEW." }, { "mdr_text_key": "387884450", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." } ], "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": "04/07/2026" } ] }