{ "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": "2955842-2024-10798", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240209", "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": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "408", "date_added": "20240210", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20221201", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1388717", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240209", "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": "L80221208 0170", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "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)241130(10)L80221208", "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": "03/04/2024;04/26/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250820", "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": "20240209", "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": "20240116", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "18682472", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240116", "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": "343285491", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "343285492", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT WAS EVALUATED BY THE ADVANCED FAILURE ANALYSIS TEAM, AND INITIAL FINDINGS WERE CONFIRMED. THE INSTRUMENT'S BLADE WAS FOUND TO BE BROKEN. THE TOOL TABLE IN THE LOGS SHOWS THAT THE INSTRUMENT WAS USED FOR WELL OVER AN HOUR, AND CLOSER MICROSCOPIC INSPECTION OF THE INSTRUMENT SHOWS USER-RELATED DAMAGE (SCRATCHES, ETC., AND A SLIGHTLY ROUGHENED TEFLON PAD), INDICATING THAT THE CRACKS THAT LIKELY LED TO THE BLADE BREAKING POTENTIALLY ORIGINATED FROM USAGE AS WELL." }, { "mdr_text_key": "339350342", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "339350343", "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 A BLADE BROKEN. THE BLADE BROKE AT ROUGHLY 3.50 MM FROM THE BASE. THE BROKEN PIECE WAS NOT RETURNED. 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)." }, { "mdr_text_key": "335072953", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. HOWEVER, AS OF THE DATE OF THIS REPORT, THE INSTRUMENT HAS NOT YET BEEN RETURNED." }, { "mdr_text_key": "335072954", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLIDING HIATAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER STATED THAT THE JAWS OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND HAD FALLEN OFF INTO THE PATIENT. THE TIP AND ALL OTHER PIECES WERE RETRIEVED AND REMOVED FROM THE PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FRAGMENTS WERE RECOVERED IMMEDIATELY AFTER THE INCIDENT BY THE INSTRUMENT MAKER AND THE ASSISTANT SURGEON ON THE OPERATING FIELD. ALL THE FRAGMENTS WERE RECOVERED. ONLY ONE WAS RECOVERED AND GIVEN WITH THE FORCEPS FOR ANALYSIS. THERE WAS NO POST-OPERATIVE EXAMINATIONS, SUCH AS X-RAYS OR ULTRASOUNDS, TO CHECK FOR REMAINING FRAGMENTS. IT HAS NEVER BEEN IN SERVICE BEFORE AS IT WAS A SINGLE-USE INSTRUMENT. THE INSTRUMENT WAS VISUALLY CHECKED BY THE INSTRUMENTALIST WHEN IT WAS OPENED. THERE WAS NO DAMAGE OR ANYTHING ABNORMAL. DISSECTION WAS BEING PERFORMED WHEN THE DEVICE FRAGMENT FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY PROBLEMS WITH THE OPERATION OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH OTHER INSTRUMENTS OR HARD MATERIAL DURING SURGERY. THE FRAGMENT FELL INSIDE THE PATIENT, BUT NOT AS A RESULT OF A COLLISION. THE JOINT WAS STRAIGHTENED BEFORE EACH REMOVAL OF THE INSTRUMENT. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE WHEN REMOVING THE INSTRUMENT THROUGH THE CANNULA. THE PATIENT DID NOT RETURN TO HOSPITAL BECAUSE OF POST-SURGICAL COMPLICATIONS RELATED TO THE RETENTION OF A FOREIGN BODY. PHOTOGRAPHIC IMAGES WAS SENT WITH THE INITIAL 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": "03/29/2024;05/24/2024" } ] }