{ "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": "2955842-2024-10224", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240118", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20231220", "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", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20240118", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220616", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "830739", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240118", "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": "L10220622 0055", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240103", "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)240630(10)L10220622", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Failure to Sense", "Detachment of Device or Device Component", "Failure to Sense", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20240118", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20231221", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18537084", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20231221", "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": "333160231", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT HAD A RECOGNITION ISSUE AND A FRAGMENT DETACHED FROM THE INSTRUMENT. THE FRAGMENT FELL INSIDE THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS INSPECTED BEFORE USE WITH NOTHING FOUND OUT OF THE ORDINARY. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DOES NOT KNOW WHAT CAUSED THE ISSUE. THE ISSUE WITH THE INSTRUMENT OCCURRED ABOUT 10 MINUTES AFTER THE PROCEDURE STARTED. THE SURGEON DID NOT NOTICE FUNCTIONALITY ISSUES DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIAL. THE INSTRUMENT WAS NOT REMOVED BEFORE BRAKEAGE AND THE WRIST WAS STRAIGHTENED. THE STAFF DID NOT FEEL RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE NOTED TO THE CANNULA. ALL FRAGMENTS WERE CONFIRMED TO BE RETRIEVED BY VISUAL INSPECTION. NO ADDITIONAL SURGICAL PROCEDURES WERE DONE TO REMOVE THE FRAGMENT. POST-OPERATIVE TESTS WERE PERFORMED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE WAS NO PATIENT HARM. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "333160232", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT AND PERFORMED FAILURE ANALYSIS EVALUATION. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE ENTIRE TEFLON PAD MISSING FROM ITS SLOT. THE MISSING MATERIAL, MEASURING APPROXIMATELY 0.43¿ X 0.11¿, WAS NOT RETURNED BACK. ADDITIONALLY, THE HANDPIECE OF THE GENERATOR WAS FINGER-TIGHTENED ON THE UNIT. NO PLAY OR LOOSENESS WAS OBSERVED BETWEEN THE INSTRUMENT AND THE HANDPIECE. ¿TEST IN PROGRESS¿ APPEARED ON THE GENERATOR¿S GRAPHIC DISPLAY. A SELF-TEST WAS COMPLETED WITH NO ISSUES AND NO ERRORS WERE IDENTIFIED. THE INSTRUMENT WAS PLACED ON THE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TEST AS WELL. THE REPORTED COMPLAINT OF RECOGNITION ISSUE WAS NOT CONFIRMED BY FAILURE ANALYSIS." } ], "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": "" } ] }