{ "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": "2955842-2024-17942", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240812", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20240708", "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": "20240812", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230420", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1935174", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240812", "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": "L81230420", "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)L80230601", "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": "09/26/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20240812", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240716", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "19962823", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240716", "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": "349049320", "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 CANNOT BE DETERMINED. AN IMAGE OF THE HARMONIC ACE INSTRUMENT WAS PROVIDED BY THE CUSTOMER AND EVALUATED. THE IMAGE APPEARS TO SHOW THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKEN OFF. THE ROOT CAUSE OF THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE." }, { "mdr_text_key": "349049321", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT BROKE WHEN THE SURGEON WAS REMOVING THE LIVER PARENCHYMA. A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT AND IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE CUSTOMER USED A BACKUP HARMONIC ACE INSTRUMENT TO CONTINUE WITH THE 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 DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE CUSTOMER REMOVED THE FRAGMENT WITH ENDOSCOPIC INSTRUMENTS. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY THE ASSISTANT AND THE NURSE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TEST WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE FRAGMENT WAS DISCARDED WHEN THE INSTRUMENT WAS STERILIZED." }, { "mdr_text_key": "353931403", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BLADE BROKEN. THE BLADE BROKE AT ROUGHLY THE BASE. A PIECE APPROXIMATELY 0.383\" X 0.085\" WAS FOUND TO BE BROKEN OFF. BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. IN ADDITION, UPDATED HARMONIC ACE INSTRUMENT LOT AND SEQUENCE NUMBERS WERE INCLUDED." }, { "mdr_text_key": "353931404", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/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": "10/11/2024" } ] }