{ "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": "2955842-2023-13458", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230513", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20210204", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "BR", "manufacturer_contact_area_code": "408", "date_added": "20230513", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20190208", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1651564", "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": "M10190208", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20210412", "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)M10190208", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Break" ], "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": "20210420", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16927975", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20210420", "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": "315184345", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TONGUE BASE RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE CURVED SHEARS INSTRUMENT BLADE BROKE OFF. A BACKUP INSTRUMENT OF THE SAME TYPE WAS USED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES IDENTIFIED. THE INSTRUMENT WAS IN USE WITHOUT ISSUE FOR APPROXIMATELY 20 MINUTES FOR HEMOSTASIS WHEN THE INSTRUMENT BLADE BROKE AND 1 FRAGMENT FELL INTO THE PATIENT'S ORAL CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. REPORTEDLY, NO INTRAOPERATIVE COLLISIONS OCCURRED AND NO RESISTANCE WAS FELT REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE CUSTOMER STATED THERE WAS NO INJURY AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "315184366", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSERT WAS FOUND WITH A BROKEN CURVED BLADE. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A BROKEN CURVED BLADE TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. BROKEN PIECE, APPROXIMATELY 0.40\" X 0.10\" WAS NOT RETURNED. MATERIAL WAS MISSING. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHED 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. ADDITIONAL OBSERVATION NOT REPORTED WAS THAT THE INSERT WAS FOUND WITH TEFLON PAD DAMAGE. MISSING MATERIAL, APPROXIMATELY 0.12 X 0.10, WAS NOT RETURNED BACK. THE CUSTOMER PROVIDED TWO PICTURES OF THE INSTRUMENT INVOLVED WITH THE COMPLAINT. AN IMAGE OF THE BROKEN CURVED BLADE WAS PROVIDED. THE IMAGE IS CONSISTENT WITH THE FAILURE ANALYSIS FINDINGS OF A BROKEN CURVED BLADE. THE BROKEN INSTRUMENT BLADE IS PART OF THE HARMONIC INSERT AND IS MOST LIKELY A RESULT OF ACCIDENTAL CONTACT WITH A HARD OBJECT DURING USE." } ], "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": "" } ] }