{ "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": "2955842-2025-24192", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250610", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250514", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250610", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231207", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1337732", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250610", "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": "480275-08", "catalog_number": "480275", "lot_number": "L81231207 0081", "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)251231(10)L81231207", "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": "06/08/2025;07/10/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250820", "health_professional": "Y", "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": "20250610", "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": "20250523", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22179515", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250523", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "375520080", "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 INSTRUMENT WAS FOUND TO HAVE THE CURVED BLADE BROKEN AT THE TIP OF THE BLADE. A PIECE APPROXIMATELY 0.542\" X 0.085\" WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. A TORQUE WRENCH WAS USED TO TIGHTEN THE ASSEMBLY UNTIL IT WAS AS TIGHT AS IT COULD BE (CLICKING SOUNDS). THE INSTRUMENT FAILED THE ENERGY RECOGNITION TEST WITH A GENERATED MESSAGE \"TIGHTEN ASSEMBLY\" ON 3 OUT OF 3 ATTEMPTS AS A RESULT OF THE BROKEN BLADE." }, { "mdr_text_key": "375520081", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "375078511", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "375078514", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 08-JUN-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE INSTRUMENT WAS INSPECTED BEFORE USE AND NO PROBLEMS WERE FOUND. THE ISSUE WAS IDENTIFIED DURING ANATOMICAL CUTTING WAS UNDERWAY WHEN THE INSTRUMENT FRAGMENTS FELL INTO THE PATIENT'S BODY. THE SURGEON WAS PUZZLED BY THE OCCURRENCE OF THIS SITUATION AND ASKED WHY IT HAPPENED. THE INSTRUMENT WAS IN USE FOR ABOUT ONE HOUR. AN ERROR WAS REPORTED BY THE INSTRUMENT ONCE DURING THE OPERATION. IT INDICATED THAT THE PRESSURE ON THE KNIFE HEAD WAS TOO HIGH. NO COLLISION OCCURRED AND THERE WAS NO RESISTANCE. THE INSTRUMENTS WERE REMOVED IN ACCORDANCE WITH THE OPERATION AND NO ABNORMALITIES OCCURRED. THE INSTRUMENT BROKE UNDER DIRECT VISION. THE FRAGMENTS HAVE BEEN RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED. THE CUSTOMER COMPLETED THE OPERATION WITH A NEW INSTRUMENT OF THE SAME TYPE. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT IS BEING RETURNED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND A BROKEN CURVED BLADE WAS NOTED ON THE HARMONIC ACE." }, { "mdr_text_key": "372103196", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGERY SURGICAL PROCEDURE, ONE HOUR AFTER THE OPERATION, THE MAIN UNIT ALARMED TO REDUCE THE PRESSURE ON THE KNIFE HEAD. WHEN THE HARMONIC ACE INSTRUMENT WAS PULLED OUT FOR INSPECTION, IT WAS INTACT. AFTER CLEANING, IT WAS INSERTED TO CONTINUE THE OPERATION. FIVE MINUTES LATER, THE KNIFE HEAD OF THE INSTRUMENT BROKE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED." }, { "mdr_text_key": "372103197", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE." } ], "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": "06/26/2025;07/16/2025" } ] }