{ "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": "2955842-2023-11670", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230331", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20230308", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230331", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221018", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1861504", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230331", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-08", "catalog_number": "480275", "lot_number": "L10221018", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230315", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)241031(10)L10221018", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Break", "Detachment of Device or Device Component", "Break", "Detachment of Device or Device Component" ], "reporter_state_code": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250803", "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": "20230331", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "70 YR", "patient_sex": "Female", "patient_weight": "65 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230308", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "16657329", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230308", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "312447721", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA REPAIR PROCEDURE, THE BLADE OF THE HARMONIC ACE INSTRUMENT FELL OFF INSIDE THE PATIENT. AT THE TAIL END OF THE DISSECTION OF THE LESSER BLOOD SUPPLY ALONG THE GREATER CURVATURE OF THE STOMACH, THE SYSTEM ASKED FOR THE SURGEON TO RELEASE TENSION/PRESSURE FROM THE INSTRUMENT AND REAPPLY THE INSTRUMENT. THE SURGEON DID AS THE SYSTEM INSTRUCTED. WHEN THE SURGEON STARTED DISSECTING AGAIN THE WARNING REAPPEARED. THE SURGEON ONCE AGAIN DID AS THE SYSTEM INSTRUCTED. AS THE SURGEON WENT IN TO GRAB THE TISSUE FOR A THIRD TIME, THE MOBILE BLADE OF THE INSTRUMENT FELL OFF. THE INSTRUMENT WAS REMOVED AND REPLACED. THE INSTRUMENT FRAGMENT/PIECE WAS FOUND AND REMOVED SAFETY FROM THE PATIENT'S ABDOMINAL CAVITY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS SEEN. THE SURGEON BELIEVE IT WAS CAUSED BY A FAULTY BUILD. THE INSTRUMENT BROKE ROUGHLY THREE QUARTERS OF THE WAY THROUGH THE CASE. NO ISSUES WERE SEEN WITH THE FUNCTIONALITY OF THE INSTRUMENT. THERE WERE NO COLLISIONS FROM ANY OTHER INSTRUMENTS. NO POST OPERATIVE TESTING WAS PERFORMED AS SURGEON WAS CONFIDENT THAT ALL PIECES WERE REMOVED. THERE WAS NO INJURY TO THE PATIENT." }, { "mdr_text_key": "312447722", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT WAS RETURNED TO ISI AND EVALUATED BY ISI FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A BLADE BROKEN. THE BLADE BROKE AT ROUGHLY 0.165¿ FROM THE BASE. THE BROKEN PIECE WAS RETURNED. CRACKED OR BROKEN BLADES ARE TRIGGERED BY ANY INADVERTENT CONTACT WITH STAPLES, CLIPS, OR OTHER INSTRUMENTS WHILE THE DEVICE IS ACTIVATED. IN ADDITION, SCRATCHES ON THE BLADE TIP MAY ALSO LEAD TO PREMATURE BLADE FAILURE. BLADE DAMAGE MAY BE DETECTED BY THE GENERATOR WITH A SOLID TONE OR AN ERROR. CRACKED OR BROKEN BLADES RESULT FROM BLADE SCRATCHES AND DAMAGE CAUSED BY CONTACT WITH OTHER INSTRUMENTS OR OTHER HARD/METAL OBJECTS (E.G., STAPLES, CLIPS, ETC.) DURING USE WHILE THE INSTRUMENT IS ACTIVATED. BLADE FRACTURES PROPAGATE FROM INITIAL CONTACT SITES DUE TO THE ULTRASONIC VIBRATION OF THE HARMONIC ACE BLADE, LEADING TO EVENTUAL/PREMATURE FAILURE (E.G., SCRATCHES AND DAMAGE RESULT IN CRACKS, WHICH THEN RESULT IN BROKEN BLADES). AN ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER: UPON VISUAL INSPECTION, THE TEFLON PAD WAS MISSING FROM THE CLAMP ARM. THE TEFLON PAD WAS NOT RETURNED ALONG WITH THE INSTRUMENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A FRAGMENT FELL FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE WITH NO PATIENT INJURY." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }