{ "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": "2955842-2023-13462", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230513", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20210316", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20230513", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200103", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1652458", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230513", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400272-03", "catalog_number": "400272", "lot_number": "M90200103", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210426", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111083", "udi_public": "(01)10886874111083(10)M90200103", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250728", "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": "20230513", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions", "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210427", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16927981", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210427", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "315180460", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE REPORTED COMPLAINT WAS CONFIRMED DURING FAILURE ANALYSIS. THE HARMONIC INSERT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE AT ROUGHLY .069 FROM THE BASE. BROKEN PIECE WAS NOT RETURNED. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR." }, { "mdr_text_key": "315180461", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE WAS NOTED TO BE BROKEN UPON FIRING. THE CUSTOMER RETRIEVED THE TIP FROM THE BODY, AND THE NURSE CHANGED THE NEW INSTRUMENT TO FINISH THE PROCEDURE. AFTER THE PROCEDURE THE NURSE DISCARDED THE BROKEN TIP. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED PRODUCT WAS INSPECTED PRIOR TO USE. THE INSTRUMENT WAS USED FOR 30 MINUTES AND BROKE UPON FIRING THE INSTRUMENT. SITE CONFIRMED A FRAGMENT OF THE HARMONIC INSERT BROKE IN THE PATIENT AND THE ASSISTANT RETRIEVED THE FRAGMENT FROM THE PATIENT'S BODY. IT IS UNKNOWN IF THE INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. NO POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR ANY REMAINING FRAGMENTS. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. NO INFORMATION WERE PROVIDED PERTAINING TO THE PATIENT'S PRE-EXISTING MEDICAL CONDITIONS AND RELEVANT TESTS/LABORATORY DATA SPECIFIC TO THE INCIDENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }