{ "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": "2955842-2025-50208", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20260107", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251211", "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", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CO", "manufacturer_contact_area_code": "", "date_added": "20260107", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250724", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "56548", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260107", "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": "480275-10", "catalog_number": "480275", "lot_number": "K10250724 0378", "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(17)270731(10)K10250724", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/05/2026;04/13/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260514", "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": "20260107", "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": "20260430", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23993916", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251213", "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": "390309677", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390309678", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2 AND H11. ADDITIONAL INFORMATION: PRIOR TO USE, HARMONIC ACE INSTRUMENT WAS INDEED INSPECTED AND THERE WAS NO VISIBLE DAMAGE OR ANYTHING OUT OF THE ORDINARY DETECTED; ALL ASPECTS OF THE INSTRUMENT APPEARED REGULAR AND FIT FOR USE. DURING THE SURGICAL PROCEDURE, THE SURGEON WAS PERFORMING DISSECTION OF FAT WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY FOUR HOURS BEFORE THE ISSUE OCCURRED. NOTABLY, THE SURGEON DID NOT NOTICE ANY FUNCTIONAL ISSUES WITH THE INSTRUMENT AT ANY POINT DURING THE SURGERY, PRIOR TO THE EVENT. FURTHERMORE, THERE WERE NO COLLISIONS BETWEEN THE INSTRUMENT AND ANY OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE. THE INSTRUMENT HAD BEEN REMOVED PRIOR TO THE BREAKAGE AND THE INSTRUMENT'S WRIST WAS STRAIGHTENED UPON REMOVAL. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA, BOTH BEFORE AND AFTER THE EVENT. NO DAMAGE WAS OBSERVED TO EITHER THE CANNULA OR THE REMAINDER OF THE INSTRUMENT AFTER THE INCIDENT. THE FRAGMENT WAS RETRIEVED BY THE ASSISTANT USING A LAPAROSCOPIC INSTRUMENT. ALL FRAGMENTS WERE VISUALLY CONFIRMED AS RETRIEVED, ENSURING THAT NOTHING REMAINED INSIDE THE PATIENT. SINCE ALL FRAGMENTS WERE SUCCESSFULLY REMOVED, NO ADDITIONAL SURGICAL PROCEDURE WAS NECESSARY FOR RETRIEVAL. NO POST-OPERATIVE IMAGING TESTS, SUCH AS AN X-RAY OR ULTRASOUND, WERE CONDUCTED TO FURTHER CHECK FOR REMAINING FRAGMENTS, AS VISUAL CONFIRMATION WAS DEEMED SUFFICIENT. THE SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS. BOTH THE INSTRUMENT AND THE ASSOCIATED ACCESSORY, AS WELL AS THE RETRIEVED FRAGMENT, ARE AVAILABLE FOR RETURN TO INTUITIVE SURGICAL (ISI) FOR FURTHER EVALUATION. HOWEVER, NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDINGS OF THE DEVICE OR THE PROCEDURE ARE AVAILABLE FOR ISI REVIEW." }, { "mdr_text_key": "401206409", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: D9, G3, G6, H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE TEFLON PAD DAMAGE AND MISSING PIECES. THE SIZE OF THE MISSING FRAGMENTS COULD NOT BE CONFIRMED, INDICATING THAT A PORTION MAY HAVE DETACHED FROM THE INSTRUMENT." }, { "mdr_text_key": "401206410", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "389491079", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY PROCEDURE, A FRAGMENT FROM THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY, USING A BACKUP HARMONIC ACE INSTRUMENT. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED." }, { "mdr_text_key": "389491081", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." } ], "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": "01/09/2026;04/30/2026" } ] }