{ "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": "2955842-2026-01151", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260114", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251221", "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_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "", "date_added": "20260114", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250814", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "133552", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260114", "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": "K10250814 0088", "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)270831(10)K10250814", "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": "05/20/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260604", "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": "20260114", "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": "20260529", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24068126", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251221", "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": "403359816", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A CLAMP ARM TEFLON PAD DAMAGE. THE TEFLON PAD WAS FOUND WITH A DETACHED FRAGMENT FROM THE TIP. THE DETACHED FRAGMENT MEASURED ROUGHLY 3 MM X 1 MM." }, { "mdr_text_key": "403359817", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "390189659", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "390189660", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HARMONIC ACE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS OBSERVED. DURING THE PROCEDURE, A FRAGMENT OF THE DEVICE FELL INSIDE THE PATIENT WHILE PERFORMING A SURGICAL TASK (THE SPECIFIC TASK WAS NOT SPECIFIED). THE SURGEON¿S OPINION ON THE CAUSE OF THE BREAKAGE OR FRAGMENT ISSUE WAS NOT PROVIDED. THE DURATION OF INSTRUMENT USE PRIOR TO THE INCIDENT WAS NOT SPECIFIED. NO FUNCTIONAL ISSUES WITH THE INSTRUMENT WERE NOTICED DURING THE SURGERY, AND THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS OR HARD MATERIALS, NOR DID THE FRAGMENT FALL DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE BREAKAGE, BUT UPON FINAL REMOVAL, THE WRIST WAS STRAIGHTENED, NO RESISTANCE WAS FELT THROUGH THE CANNULA, AND THERE WAS NO DAMAGE OBSERVED TO THE CANNULA OR THE INSTRUMENT. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT, AND COMPLETE RETRIEVAL WAS CONFIRMED BY VISUAL INSPECTION, REQUIRING NO ADDITIONAL SURGICAL PROCEDURES SUCH AS LAPAROSCOPY OR OPEN SURGERY. NO POST-OPERATIVE IMAGING WAS PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT PATIENT INJURY OR SUBSEQUENT HOSPITAL RETURN FOR COMPLICATION RELATED TO A RETAINED FOREIGN OBJECT. THE INSTRUMENT AND ASSOCIATED ACCESSORIES ARE AVAILABLE FOR RETURN TO ISI FOR EVALUATION, ALTHOUGH THE RETRIEVED FRAGMENT WILL NOT BE RETURNED. NO PHOTOGRAPHIC IMAGES OR PROCEDURAL VIDEOS WERE AVAILABLE FOR ISI REVIEW." } ], "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": "05/29/2026" } ] }