{ "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": "2955842-2025-21117", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250523", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250427", "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": "20250523", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230810", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2505042", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250523", "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": "L80230810 0154", "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(10)L80230810", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/23/2025", "mfr_report_type": "Follow-Up", "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": "20250523", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "51 YR", "patient_sex": "Female", "patient_weight": "92 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250428", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22081039", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250428", "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": "371039200", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A REVIEW OF IMAGES PROVIDED BY THE CUSTOMER SHOW A HARMONIC ACE INSTRUMENT WITH A BROKEN OFF BLADE THAT IS STUCK TO TISSUE. BASED ON THE IMAGES ALONE, A ROOT CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. THE PATIENT IS OF UYGHUR ETHNICITY WITH A BMI OF 38.3." }, { "mdr_text_key": "371039201", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT APPROXIMATELY 2 HOURS INTO A DA VINCI-ASSISTED HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC LYMPH NODE DISSECTION PROCEDURE, THE SYSTEM DISPLAYED A \"REDUCE BLADE PRESSURE\" MESSAGE WHILE THE CUSTOMER WAS USING A HARMONIC ACE INSTRUMENT. THE INSTRUMENT WAS REMOVED, CLEANED, AND REASSEMBLED AT THE BEDSIDE. HOWEVER, AFTER REINSTALLING THE HARMONIC ACE INSTRUMENT ONTO THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND TESTING THE INSTRUMENT, THE BLADE TIP FRACTURED. A FRAGMENT REPORTEDLY FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME SURGICAL PROCEDURE. THE SURGEON CHOSE TO REPLACE THE INSTRUMENT WITH A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TO CONTINUE PARA-AORTIC LYMPH NODE DISSECTION AND TO COMPLETE THE PROCEDURE AS PLANNED. NO POSTOPERATIVE IMAGING WAS PERFORMED." }, { "mdr_text_key": "373301588", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, H3, ANNEX CODES: C, D. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS (FA) AND WAS ABLE TO CONFIRM AND REPLICATE THE CUSTOMER-REPORTED ISSUE OF A BLADE FRACTURE AND DISPLAYING AN ALERT. THE INSTRUMENT WAS FOUND TO HAVE ONE BLADE BROKEN AT THE BASE. A PIECE APPROXIMATELY .3475\" X .0760\" WAS FOUND TO BE BROKEN OFF AND WAS NOT RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE. DURING USE WHILE THE INSTRUMENT IS ACTIVATED, BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. BLADE FRACTURES PROPAGATE FROM INITIAL CONTACT SITES DUE TO THE ULTRASONIC VIBRATION OF THE HARMONIC ACE BLADE, LEADING TO EVENTUAL/PREMATURE FAILURE." }, { "mdr_text_key": "373301589", "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": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/24/2025" } ] }