{ "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": "2955842-2024-11277", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240215", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20240110", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20240215", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220203", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "908764", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240215", "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": "400272-03", "catalog_number": "400272", "lot_number": "L90220203", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240214", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111083", "udi_public": "(01)10886874111083(10)L90220203", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250825", "health_professional": "Y", "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": "20240215", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20240119", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18714731", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240119", "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": "335492394", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. DEVICE. THE HARMONIC INSERT WAS FOUND TO HAVE A BROKEN BLADE. THE BLADE BROKE ROUGHLY 0.15¿ FROM THE BASE. THE BROKEN PIECE WAS RETURNED." }, { "mdr_text_key": "335492476", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE. A FRAGMENT BROKE OFF FROM THE INSTRUMENT AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE USER COMPLETED THE PROCEDURE USING A BACKUP HARMONIC ACE INSTRUMENT WITH NO FURTHER ISSUE REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENT(S) WERE ALL CONFIRMED TO BE RETRIEVED THROUGH VISUALIZATION OF AN ENDOSCOPE BY THE SURGEON, NURSE, AND SURGICAL ASSISTANT. THERE WAS NO ADDITIONAL PROCEDURE OR POST-OPERATIVE TEST PERFORMED. THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE INSTRUMENT WAS IN USE FOR HALF AN HOUR PRIOR TO BREAKING AND WHILE THE SURGEON WAS DISSECTING. THERE WAS NO ISSUE WITH FUNCTIONALITY OF THE INSTRUMENT AND NO INSTRUMENT COLLISION. THE INSTRUMENT WAS REMOVED DURING THE PROCEDURE PRIOR TO THE BREAKAGE BUT THERE WAS NO RESISTANCE UPON REMOVAL. UPON FINAL REMOVAL OF THE INSTRUMENT, THERE WAS NO RESISTANCE THROUGH THE CANNULA, NO DAMAGE TO THE CANNULA, AND NO FURTHER DAMAGE TO THE INSTRUMENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS." } ], "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": "" } ] }