{ "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": "2955842-2022-10277", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20220218", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20220113", "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": "20211124", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "529143", "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": "L90211125 0008", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)231130(10)L90211125", "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": "02/24/2022", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "32 YR", "patient_sex": "Male", "patient_weight": "85 KG", "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": "13558255", "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": "290694748", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE HARMONIC ACE INSTRUMENT FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE INSTRUMENT LOG OF THE HARMONIC ACE (PART # 480275; / LOT # L90211125-0008) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THE LOGS, THE INSTRUMENT WAS USED ON (B)(6) 2022 ON SYSTEM SK3940. THIS IS A SINGLE USE INSTRUMENT. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, IT WAS ALLEGED THE JAW FROM A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE." }, { "mdr_text_key": "290694749", "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, THE JAW FROM A HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED IN THE SAME PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. ON 01-FEB-2022, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE ROBOTICS COORDINATOR. THE FRAGMENT WAS RETRIEVED IMMEDIATELY AFTER IT BROKE OFF THE INSTRUMENT USING A LAPAROSCOPIC LOCKING GRASPER. NO POST-OPERATIVE TESTS WERE NEEDED AS THE FRAGMENT WAS LARGE ENOUGH TO SEE. SHE ESTIMATED THAT THE INSTRUMENT WAS IN USE BETWEEN 45 - 60 MINUTES. THE INSTRUMENT WAS INSPECTED BEFORE USE AND NOTHING WAS OUT OF THE ORDINARY. THE INSTRUMENT BROKE WHEN THEY WERE DISSECTING THE LIVER TISSUE. RIGHT BEFORE THE FRAGMENT BROKE, THEY RECEIVED A MESSAGE - RELAX PRESSURE ON JAWS. THERE WAS NO INSTRUMENT COLLISION AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD OBJECTS WHILE IN THE PATIENT. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH A NEW HARMONIC INSTRUMENT. THE PATIENT HAS NOT EXPERIENCED ANY ISSUES POST-SURGICAL PROCEDURE. THE INSTRUMENT AND FRAGMENT WAS GIVEN TO THE HOSPITAL RISK MANAGEMENT TEAM AND WILL NOT BE RETURNED TO ISI." }, { "mdr_text_key": "328502689", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "328502690", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS EVENT FOR THE HARMONIC ACE INSTRUMENT WAS DETERMINED TO BE A DUPLICATE OF THE EVENT THAT WAS SUBMITTED IN THE REPORT WITH PATIENT IDENTIFIER (B)(6)." } ], "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": "03/24/2022" } ] }