{ "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": "2955842-2026-26313", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260527", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20260319", "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": "HK", "manufacturer_contact_area_code": "", "date_added": "20260527", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250908", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "140119", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260527", "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": "480275-12", "catalog_number": "480275", "lot_number": "K10250908 0179", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/10/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260527", "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" ] } ], "distributor_city": "", "date_report": "20260707", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25302293", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260429", "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": "402454692", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PORTION OF THE HARMONIC ACE INSTRUMENT BROKE. HOWEVER, IT IS UNCLEAR IF A FRAGMENT FROM THE INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER REPLACED THE INSTRUMENT WITH A SECOND HARMONIC ACE INSTRUMENT FROM THE SAME LOT. THE SECOND HARMONIC ACE INSTRUMENT REPORTEDLY ALSO BROKE AND A FRAGMENT FELL INSIDE THE PATIENT. THE CUSTOMER THEN INSTALLED A THIRD HARMONIC ACE INSTRUMENT FROM A DIFFERENT LOT AND WAS ABLE TO COMPLETE THE PROCEDURE WITH NO ISSUES. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE INSTRUMENTS AND BROKEN PIECES WERE DISCARDED BASED ON THE HOSPITAL'S DISPOSAL PROTOCOL. THERE WERE NO COLLISIONS BETWEEN INSTRUMENTS OR HARD OBJECTS REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "402454693", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT WILL NOT BE RETURNED. IMAGES PROVIDED BY THE CUSTOMER WERE REVIEWED. IN TWO IMAGES, THE TEFLON PAD OF A HARMONIC INSTRUMENT APPEARS TO HAVE SOME MISSING PIECES. IN ANOTHER IMAGE, A BROKEN BLADE IS SEEN BUT NO MISSING PIECES ARE OBSERVED. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT #2955842-2026-26314 FOR MDR SUBMISSION OF THE SECOND BROKEN HARMONIC ACE INSTRUMENT." }, { "mdr_text_key": "407432944", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED B3, H2, H11, ANNEX B, ANNEX C, ANNEX D. THE AFFECTED HARMONIC ACE INSTRUMENT WILL NOT BE RETURNED. THE SITE RETURNED 10 UNUSED HARMONIC ACE INSTRUMENTS FROM THE SAME LOT FOR FAILURE ANALYSIS. THE INSTRUMENTS WERE FULLY FUNCTIONAL. NO PRODUCT ISSUES WAS FOUND." }, { "mdr_text_key": "407432945", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO 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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/07/2026" } ] }