{ "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": "2955842-2025-47527", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251208", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251111", "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": "408", "date_added": "20251208", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250911", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "522727", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251208", "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": "K10250911 0249", "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)270930(10)K10250911", "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": "04/22/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260513", "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": "20251208", "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", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260501", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23751780", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251113", "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": "401134532", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "401134533", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE WAS ANALYZED AND FOUND TO HAVE MECHANICAL INDENTATIONS/BURRS WITH BLADE DAMAGE AT ITS BASE. THE BLADE DID NOT HAVE CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE. ADDITIONAL OBSERVATION RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A GENERATOR SELF-TEST (AKA INITIALIZATION) FAILURE DURING IN-HOUSE TESTING LIKELY ATTRIBUTED TO THE BLADE DAMAGE." }, { "mdr_text_key": "387123076", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE HARMONIC INSTRUMENT WAS BORROWED FROM THE MAIN BUILDING. THREE INSTRUMENTS WERE IN USE. IT TOUCHED THE MARYLAND ONCE, AND THE BLADE BROKE, THE CUSTOMER USED A NEW ONE, BUT WITHIN FIVE MINUTES, AN ERROR MESSAGE APPEARED, AND THE INSRUMENT WAS REPLACED. A 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: PRIOR TO USE, THE SURGICAL INSTRUMENT WAS INSPECTED AND FOUND TO BE FREE OF ANY DAMAGE OR ANYTHING UNUSUAL. DURING THE PROCEDURE, WHILE THE SURGEON WAS DISSECTING TISSUE, A FRAGMENT OF THE DEVICE FELL INSIDE THE PATIENT. THE EXACT CAUSE OF THE INSTRUMENT BREAKAGE OR THE FRAGMENT FALLING ISSUE REMAINS UNKNOWN. THE INSTRUMENT HAD BEEN IN USE FOR LESS THAN 30 MINUTES BEFORE THE INCIDENT OCCURRED, AND THE SURGEON DID NOT NOTICE ANY ISSUES WITH ITS FUNCTIONALITY DURING THE OPERATION. THERE WAS, HOWEVER, A COLLISION BETWEEN THIS INSTRUMENT AND ANOTHER INSTRUMENT OR HARD MATERIAL DURING SURGERY, AND IT WAS DURING SUCH AN INSTRUMENT TIP/ACCESSORY COLLISION THAT THE FRAGMENT FELL INTO THE PATIENT. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE. UPON FINAL REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED AS PER STANDARD PROTOCOL, AND SURGICAL STAFF REPORTED NO RESISTANCE FELT WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA. AFTER THE INCIDENT, THERE WAS NO NOTICEABLE DAMAGE TO EITHER THE CANNULA OR THE INSTRUMENT, OTHER THAN THE ORIGINAL BREAKAGE EVENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE, AND VISUAL CONFIRMATION ENSURED THAT ALL FRAGMENTS WERE RECOVERED; NO FURTHER SURGERY WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE IMAGING SUCH AS X-RAYS OR ULTRASOUND WAS PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT CONVERSION TO OPEN OR LAPAROSCOPIC TECHNIQUES, AND THERE WAS NO INJURY TO THE PATIENT. ADDITIONALLY, THE PATIENT HAS NOT RETURNED TO THE HOSPITAL WITH ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINED FOREIGN OBJECTS. BOTH THE INSTRUMENT AND THE ASSOCIATED ACCESSORY ARE AVAILABLE FOR RETURN TO ISI FOR EVALUATION, AND THE RETRIEVED FRAGMENT WILL ALSO BE RETURNED. HOWEVER, PHOTOGRAPHIC IMAGES OF THE DEVICE OR ANY VIDEO RECORDING OF THE PROCEDURE ARE NOT AVAILABLE FOR ISI REVIEW." }, { "mdr_text_key": "387123077", "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": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/01/2026" } ] }