{ "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": "2955842-2024-23284", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20241219", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20241125", "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": "20241219", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240314", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2024427", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241219", "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": "L80240314 0378", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20241216", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "AK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20241219", "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": "20241126", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20977433", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241126", "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": "359592990", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT AND COMPLETED FAILURE ANALYSIS INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN MAIN TUBE APPROXIMATELY 3.440\" FROM THE DISTAL TIP. NO MATERIAL WAS FOUND MISSING. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DID NOT SHOW DAMAGE. THE INSTRUMENT WAS ALSO FOUND TO HAVE THE TEFLON PAD MISSING FROM THE CLAMP ARM. THE MISSING TEFLON PAD WAS NOT RETURNED. THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE FRAGMENT MEASURED APPROXIMATELY 0.105\" X 0.429\" AND WAS NOT RETURNED WITH THE INSTRUMENT. THE FRAGMENT ORIGINATED FROM THE CLAMP ARM." }, { "mdr_text_key": "359592991", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT WAS HAVING DIFFICULTY BEING REMOVED FROM THE PATIENT. THE SCRUB TECHNICIAN ASKED THE SURGEON TO VISUALIZE THE INSTRUMENT WHILE SHE ATTEMPTED TO REMOVE IT. AFTER SEVERAL ATTEMPTS AND TROUBLESHOOTING SUCH AS RE-SEATING THE INSTRUMENT, PRESSING THE ROBOTIC BUTTONS, AND VARYING ANGLES OF PULL, THE SURGEON SCRUBBED IN AND REMOVED THE INSTRUMENT WITH FORCE. WHILE INSPECTING THE INSTRUMENT, THEY WERE ABLE TO OBSERVE THAT IT WAS BROKEN. THE BROKEN PIECE WAS REMOVED IN THE RETRIEVAL BAG WITH THE GALLBLADDER. THE CUSTOMER REMOVED THE INSTRUMENT FROM THE FIELD. THE TIP OF THE HARMONIC ACE JAW HAD BROKEN OFF AS WELL AS THE PORTION AROUND THE WRIST, WHICH WAS NOT KNOWN AT THE TIME AND UNACCOUNTED FOR WHEN REMOVING THE EQUIPMENT FROM THE FIELD AND THE PATIENT. IT IS UNKNOWN WHICH PORTION OF THE DAMAGE TO THE INSTRUMENT OCCURRED AT WHAT TIME. THE INSTRUMENT WAS STUCK AND NEEDED TO BE FORCEFULLY REMOVED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }