{ "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": "2955842-2025-23896", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250606", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20250212", "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", "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "SP", "manufacturer_contact_area_code": "408", "date_added": "20250606", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230126", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2788943", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250606", "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": "L81230126 0230", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250506", "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)250131(10)L81230126", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20250606", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250212", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22162005", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250212", "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": "371941927", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENUCLEATION OF ESOPHAGEAL TUMOR SURGICAL PROCEDURE, THE JAWS OF THE HARMONIC ACE FELL OFF INTO THE PATIENT. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS NOT INSPECTED MORE THOROUGHLY THAN USUAL. NOTHING ABNORMAL WAS NOTED. THE SURGICAL TASK BEING PERFORMED WHEN THE DEVICE FRAGMENTS FELL INSIDE THE PATIENT WAS DISSECTION. THE SURGEON DOES NOT KNOW HOW TO EXPLAIN THE BREAKAGE. HE THOUGHT THAT MANUFACTURING DEFECTS CONTRIBUTED TO THE INSTRUMENT BREAKAGE. THE INSTRUMENT WAS IN USE FOR ABOUT 30 TO 45 MINUTES. JUST BEFORE THE BREAKAGE, THE SURGEON NOTICED A NON-INTUITIVE MOVEMENT, AND THEN WHEN HE OPENED THE JAWS (IN THE AIR), THEY SLOWLY OPENED UNTIL THEY BROKE. THERE WASN¿T ANY SIGNIFICANT COLLISION DURING THE SURGERY. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DUE TO AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE CUSTOMER COULD NOT RECALL IF THE INSTRUMENT WAS REMOVED PRIOR TO THE BREAKAGE, BUT THE FIRST ASSISTANT WAS HIGHLY EXPERIENCED, AND IT WAS NOT VERY LIKELY THAT SHE COULD HAVE MADE THIS MISTAKE. THE CUSTOMER COULD NOT CONFIRM IF THE STAFF FELT ANY RESISTANCE UPON THE FINAL REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA, IF THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED, OR IF THERE WAS ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. THERE WAS NO DAMAGE TO THE CANNULA. NO OTHER DAMAGE WAS NOTED. THE FRAGMENT WAS RETRIEVED WITH A ROBOTIC GRASPER. IT WAS ONLY ONE FRAGMENT, AND IT WAS TAKEN OUT THROUGH THE AUXILIARY PORT. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. THERE WERE NO POSTOPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR THE REMAINING FRAGMENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE FRAGMENT WILL NOT BE RETURNED FOR FAILURE ANALYSIS. THE CUSTOMER ATTACHED AN IMAGE OF THE SMALL FRAGMENT OF THE SURGERY PRIOR TO THE ISSUE BUT NOT DURING IT." }, { "mdr_text_key": "371941928", "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 BROKEN BLADE. THE BLADE BROKE AT ROUGHLY 5MM FROM THE BASE. THE BROKEN PIECE WAS NOT RETURNED. THE SIZE OF THE MISSING PIECE WAS APPROXIMATELY 10.95 MM X 2.65 MM. COMPONENTS ADJACENT TO THE BROKEN BLADE/CLAMP ARM DID NOT SHOW DAMAGE. IMAGE REVIEW WAS PERFORMED, AND A BROKEN CURVED BLADE WAS NOTED ON THE HARMONIC ACE INSTRUMENT. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. ." } ], "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": "" } ] }