{ "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": "2955842-2025-49893", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251230", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251208", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20251230", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241127", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "139674", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251230", "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": "L11241127 0357", "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": "", "udi_public": "", "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": "05/27/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "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": "20251230", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "50 YR", "patient_sex": "Male", "patient_weight": "78 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260608", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23922380", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251209", "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": "388809554", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, 68 MINUTES INTO THE PROCEDURE, THE ULTRASONIC SCALPEL TIP SUDDENLY SNAPPED ON THE HARMONIC ACE. THE FIRST ASSISTANT THEN SAFELY RETRIEVED THE INSTRUMENT AND ALL FRAGMENTS UNDER VISUAL INSPECTION. THROUGHOUT THIS PROCESS, THERE WAS NO COLLISION OF THE EQUIPMENT, NOR WAS ANY HARD OBJECT CLAMPED. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGICAL INSTRUMENT IN QUESTION WAS INSPECTED PRIOR TO USE, WITH STAFF CONFIRMING THAT THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED - ALL WAS WELL. DURING THE PROCEDURE, THE DEVICE FRAGMENT FELL INSIDE THE PATIENT WHILE THE INSTRUMENT WAS BEING USED FOR GRASPING. THE SURGEON BELIEVES THAT THE BREAKAGE WAS CAUSED BY METAL FATIGUE, AND RECORDS INDICATE THAT THE INSTRUMENT HAD BEEN IN USE FOR 68 MINUTES PRIOR TO THE INCIDENT. NO FUNCTIONAL ISSUES WERE NOTICED BY THE SURGEON DURING THE OPERATION. THE INSTRUMENT WAS NOT REMOVED BEFORE THE BREAKAGE, AND THE WRIST WAS NOT STRAIGHTENED PRIOR TO THAT MOMENT. UPON FINAL REMOVAL OF THE INSTRUMENT AFTER THE EVENT, HOWEVER, THE WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE WHILE REMOVING THE DEVICE THROUGH THE CANNULA. FURTHERMORE, POST-EVENT INSPECTION REVEALED NO DAMAGE TO THE CANNULA AND NO ADDITIONAL DAMAGE TO THE INSTRUMENT ITSELF BEYOND THE ORIGINAL BREAKAGE. RETRIEVAL OF THE FRAGMENTS WAS PERFORMED UNDER DIRECT VISUAL INSPECTION USING LAPAROSCOPIC INSTRUMENTS, AND ALL FRAGMENTS WERE CONFIRMED VISUALLY REMOVED FROM THE PATIENT. NO ADDITIONAL SURGICAL PROCEDURE WAS NECESSARY TO ACHIEVE THIS - LAPAROSCOPY WAS SUFFICIENT - AND NO POST-OPERATIVE IMAGING STUDIES, SUCH AS X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR RETAINED FRAGMENTS. THE REMAINDER OF THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED, WITH NO INJURY TO THE PATIENT AND NO POST-SURGICAL COMPLICATIONS REPORTED. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY RELATED ISSUES. BOTH THE INSTRUMENT AND ANY ASSOCIATED ACCESSORIES ARE AVAILABLE FOR RETURN TO INTUITIVE SURGICAL (ISI) FOR EVALUATION, AND THE RETRIEVED FRAGMENT WILL ALSO BE SENT BACK TO ISI AS PART OF THE INVESTIGATION. HOWEVER, THERE WERE NO PHOTOGRAPHIC IMAGES OF THE DEVICES NOR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE FOR ISI REVIEW, AS THE SURGICAL PROCESS WAS NOT RECORDED." }, { "mdr_text_key": "388809555", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. ADDITIONAL SECTION A DEMOGRAPHIC INFORMATION: BODY MASS INDEX (BMI): 26.4 KG/M2. HEIGHT AND UNIT (CM/INCHES): 172 CM." }, { "mdr_text_key": "407437028", "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 INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE BLADE BROKEN AT THE BASE. A PIECE APPROXIMATELY 5.16 MM X 2.14 MM WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT. IN ADDITION, PRODUCT LOT AND SEQUENCE WERE UPDATED IN SECTION D4 BASED ON ADDITIONAL INFORMATION OBTAINED." }, { "mdr_text_key": "407437029", "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/08/2026" } ] }