{ "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": "2955842-2024-19607", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240918", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20240716", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20240918", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231102", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1226292", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240918", "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": "L81231102 0084", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240826", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(10)L81231102", "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": "MN", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "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": "20240918", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "46 YR", "patient_sex": "Female", "patient_weight": "73 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240822", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20247913", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240822", "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": "352082214", "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 A BLADE BROKEN. THE BLADE BROKE AT ROUGHLY THE BASE. A PIECE APPROXIMATELY 0.570\" X 0.085\" WAS FOUND TO BE BROKEN OFF. BROKEN PIECE WAS RETURNED. COMPONENTS ADJACENT TO THIS BROKEN BLADE DO NOT SHOW DAMAGE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS." }, { "mdr_text_key": "352082215", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, WHEN DISSECTING THROUGH THE ROUND LIGAMENT ON THE RIGHT SIDE OF THE UTERUS THERE WAS AN AUDIBLE SNAP/CRACK OF THE HARMONIC ACE INSTRUMENT. WHEN THE SURGEON PULLED THE INSTRUMENT BACK TO INVESTIGATE, THEY NOTICED THAT THE MOBILE BLADE OF THE INSTRUMENT WAS NO LONGER ATTACHED. THE BLADE WAS LOCATED IN THE PATIENT'S PELVIS, UNDER THE UTERUS AND REMOVED UNDER DIRECT VISION BY THE ASSISTING SURGEON AT BEDSIDE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THE TECHNICIAN THAT RECEIVED THE HARMONIC ONTO THE FIELD DID NOT NOTICE ANY DAMAGE TO THE INSTRUMENT. THE ISSUE WAS IDENTIFIED DURING ROBOTIC-ASSISTED HYSTERECTOMY, WHILE THE SURGEON WAS DISSECTING THE RIGHT SIDE OF THE UTERUS. PER THE SURGEON, THE ISSUE WAS CAUSED DUE TO A MANUFACTURING ERROR. THE REPORTER EXPLAINED TO THE SURGICAL STAFF THAT HARMONIC DOES NOT HAVE A WRIST. SNAPPING THE WORKING JAW OF THE HARMONIC BY APPLYING TOO MUCH PRESSURE WHILE TRYING TO TWIST THE INSTRUMENT AT THE SAME TIME WILL RESULT IN AN INSTRUMENT FAILURE. THE REPORTER CONTACTED THE ISI CSR SO THEY COULD REACH OUT TO THE SURGEON TO FURTHER DISCUSS THE ISSUE. THE HARMONIC WAS IN USE FOR 40-30MINS BEFORE IT WAS DAMAGED. THE SURGEON DID NOT NOTICE ANYTHING WRONG IN THE FUNCTIONALITY OF THE HARMONIC. THERE WERE NOT ANY INTERNAL COLLISIONS OF THE INSTRUMENTS DURING THE CASE. THE FRAGMENT FELL INTO THE PATIENT'S LOWER PELVIS AREA. THE HARMONIC REMAINED INSIDE OF THE PATIENT UNTIL IT WAS DAMAGED. NO RESISTANCE WAS FELT BY STAFF WHEN REMOVING THE INSTRUMENT. CANNULA WAS IN THE SAME CONDITION IT WAS AT THE BEGINNING OF THE CASE. THE WORKING JAW OF THE HARMONIC WAS NOTED TO BE MISSING. ALL FRAGMENTS WERE RETRIEVED BY THE ASSISTING SURGEON WITH A GRASPER AND CONFIRMED UNDER DIRECT VISUALIZATION BY THE OPERATING SURGEON, ASSISTING SURGEON, AND THE TECHNICIAN AT THE BEDSIDE. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THE SURGEON FELT THAT THE ONE FRAGMENT WAS REMOVED IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH ANOTHER HARMONIC ACE. THERE WAS NO HARM TO THE PATIENT WAS REPORTED BY THE OPERATIVE SURGEON. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THIS SURGEON DID TAKE PHOTOS THROUGHOUT THE CASE, BUT THE REPORTER WILL CONTACT THE MANAGER TO RELEASE THEM." } ], "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": "" } ] }