{ "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": "2955842-2022-10276", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220218", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20211217", "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": "20220218", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200423", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "474083", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220218", "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": "M91200428 0045", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20220204", "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)220430(10)M91200428", "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": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20220218", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20220125", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "13558238", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220125", "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": "289523702", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, HALF OF THE TIP FROM A HARMONIC ACE INSTRUMENT BROKE OFF IN THE ABDOMINAL CAVITY DURING LIVER RESECTION. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE SURGEON WAS USING THE HARMONIC ACE INSTRUMENT DURING A PARTIAL LIVER RESECTION. THE CASE WAS ALMOST COMPLETED, BUT THE FRAGMENT BROKE DURING DISSECTION. THE TEAM NOTICED THIS WHEN THE SURGEON WAS MOVING THE INSTRUMENT TO A DIFFERENT AREA OF THE LIVER. THIS CAUSED A 20-30 MINUTE DELAY IN THE CASE. THE FRAGMENT WAS FOUND AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE BY USING A LAPAROSCOPIC GRASPER. IT WAS CONFIRMED TO BE REMOVED VISUALLY SO NOT POST-OPERATIVE TESTS WERE NEEDED. BOTH THE FRAGMENT AND THE INSTRUMENT HAVE BEEN GIVEN TO RISK MANAGEMENT. THE CASE WAS LATER CONVERTED TO AN OPEN PROCEDURE DUE TO PATIENT ANATOMY AND NOT DUE TO THE MALFUNCTION OF THE INSTRUMENT." }, { "mdr_text_key": "289523703", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND WITH A BROKEN CURVED BLADE. A BROKEN PIECE, APPROXIMATELY 0.48\" X 0.10\" WAS RETURNED. NO MATERIAL APPEARED TO BE MISSING AS THE BROKEN ASSEMBLY WAS PIECED BACK TOGETHER. 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. THE ROOT CAUSE OF THIS FAILURE IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE. ADDITIONAL OBSERVATION NOT REPORTED BY THE CUSTOMER WAS ALSO IDENTIFIED. THE INSTRUMENT WAS FOUND WITH THE ENTIRE TEFLON PAD MISSING. MISSING MATERIAL, APPROXIMATELY 0.44¿ X 0.10¿ WAS NOT RETURNED WITH THE INSTRUMENT. THE ROOT CAUSE OF THIS FAILURE IS ATTRIBUTED TO MISHANDLING/MISUSE. FA FOUND THE ADDITIONAL FAILURE OF TEFLON PAD DAMAGE NOT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. A REVIEW OF THE INSTRUMENT LOG OF THE HARMONIC ACE (PART # 480275-08; / LOT # M91200428-0045) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2021 ON SYSTEM SK1517. THIS IS A SINGLE USE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS FOR THIS PRODUCT. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, IT WAS ALLEGED THAT HALF OF THE TIP FROM A HARMONIC ACE INSTRUMENT BROKE OFF IN THE ABDOMINAL CAVITY. THE CUSTOMER WAS ABLE TO RETRIEVE THE FRAGMENT IN THE SAME PROCEDURE. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE MISSING PATIENT INFORMATION WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE IS NOT APPLICABLE. THE PRODUCT IS NOT IMPLANTABLE. IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA." } ], "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": "" } ] }