{ "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": "2955842-2024-10698", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240205", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20240109", "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": "KS", "manufacturer_contact_area_code": "408", "date_added": "20240205", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230714", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2031460", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240205", "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": "L83230714 0058", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240130", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)250731(10)L83230714", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/01/2024", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250819", "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": "20240205", "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": "20240109", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18647172", "removal_correction_number": "N/A", "number_devices_in_event": "", "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": "334611344", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYROIDECTOMY PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN. THE FRAGMENT FELL INSIDE THE PATIENT¿S CAVITY AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT OF THE SAME KIND. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE WAS FOUND. AFTER THE CUSTOMER USED THE INSTRUMENT FOR 20 TO 30 MINUTES TO GRASP TISSUE, THE INSTRUMENT BROKE AND THE FRAGMENT(S) FELL INSIDE THE PATIENT. ALL THE FRAGMENTS WERE RETRIEVED DURING SAME PROCEDURE AND CONFIRMED BY MATCHING THE FRAGMENTS TO THE INSTRUMENT. POST-OPERATIVE TESTS WERE NOT PERFORMED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT AND THE INSTRUMENT DID NOT COLLIDE WITH ANY HARD MATERIALS OR OTHER INSTRUMENTS. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE). UPON FINAL REMOVAL OF THE INSTRUMENT, THE INSTRUMENT'S WRIST WAS STRAIGHTENED, AND THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. NO OTHER DAMAGE WAS NOTED ON THE INSTRUMENT AFTER THE EVENT OCCURRED AND THE CANNULA HAD NO ISSUE. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." }, { "mdr_text_key": "334611345", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS REQUESTED FOR RETURN OF THE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. AS OF THE DATE OF THIS REPORT, ISI HAS NOT RECEIVED THE INSTRUMENT. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTER FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "340132090", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "340132091", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE TEFLON PAD DAMAGE. A PIECE OF THE TEFLON PAD WAS BROKEN AT THE DISTAL END OF THE PAD. THE MATERIAL WAS RETURNED WITH THE INSTRUMENT AND THERE WAS NO MATERIAL FOUND TO BE MISSING. THE COMPLAINT REGARDING PHYSICAL DAMAGE WAS CONFIRMED BY FAILURE ANALYSIS. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: D4 (BATCH SEQUENCE WAS ADDED TO THE LOT NUMBER)." } ], "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": "02/25/2024" } ] }