{ "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": "2955842-2025-48882", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "N", "date_received": "20251219", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251130", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20251219", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241031", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "652150", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251219", "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": "480275-10", "catalog_number": "480275", "lot_number": "L12241031 0074", "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": "", "udi_public": "", "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": "03/14/2026;05/21/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20251219", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "64 YR", "patient_sex": "Male", "patient_weight": "74 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "Asian", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260612", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23849914", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251130", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "388107802", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "388107803", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER CYSTECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THAT PART OF THE HARMONIC ACE INSTRUMENT SCALPEL PAD HAD COME LOOSE. IMMEDIATE SAFETY TESTING IN A SECURE AREA REVEALED THAT THE PAD HAD COMPLETELY DETACHED. ALL FRAGMENTS AND THE INSTRUMENT WERE SUBSEQUENTLY RETRIEVED UNDER DIRECT VISUAL INSPECTION. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS THOROUGHLY INSPECTED PRIOR TO USE, AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED; IT APPEARED TO BE IN NORMAL WORKING CONDITION WHEN THE SURGICAL PROCEDURE BEGAN. DURING THE OPERATION, THE INCIDENT OCCURRED WHILE THE INSTRUMENT WAS BEING USED FOR GRASPING TISSUE. THE SURGEON BELIEVES THE FRAGMENT ISSUE WAS POTENTIALLY CAUSED BY THE GASKET FALLING OUT DUE TO A COMBINATION OF THE HIGH TEMPERATURE OF THE JAWS (WHICH MAY HAVE SOFTENED THE GASKET) AND THE MECHANICAL STRESSES FROM CLAMPING AND PULLING TISSUE. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY 74 MINUTES BEFORE THE ISSUE AROSE. THROUGHOUT THE SURGICAL PROCEDURE, THE INSTRUMENT FUNCTIONED AS EXPECTED WITH NO REPORTED ISSUES, AND THE SURGICAL STAFF DID NOT NOTICE ANY MALFUNCTIONS. ALTHOUGH THERE IS A POSSIBILITY THAT THE INSTRUMENT MAY HAVE COLLIDED WITH ANOTHER INSTRUMENT OR HARD MATERIAL, THERE ARE NO DEFINITE OBSERVATIONS OR REPORTS CONFIRMING THIS. NONETHELESS, THE FRAGMENT DID FALL INTO THE PATIENT DURING AN INSTRUMENT TIP/ACCESSORY COLLISION. THE INSTRUMENT WAS NOT REMOVED PRIOR TO THE BREAKAGE; ALL HANDLING AND RESISTANCE DETAILS PERTAIN ONLY TO ITS FINAL REMOVAL. UPON THE FINAL REMOVAL, THE WRIST OF THE INSTRUMENT WAS STRAIGHTENED, AND THE STAFF DID NOT FEEL ANY RESISTANCE AS IT WAS WITHDRAWN THROUGH THE CANNULA. INSPECTION AFTER REMOVAL SHOWED NO DAMAGE TO THE CANNULA AND NO FURTHER NOTICEABLE DAMAGE TO THE INSTRUMENT ITSELF. THE FRAGMENTS THAT FELL INSIDE THE PATIENT WERE RETRIEVED USING LAPAROSCOPIC INSTRUMENTS, AND ALL WERE VISUALLY CONFIRMED TO BE REMOVED¿NO ADDITIONAL SURGICAL PROCEDURES WERE NECESSARY. POSTOPERATIVE CHECKS WITH IMAGING (SUCH AS X-RAY OR ULTRASOUND) WERE NOT PERFORMED, AS VISUAL CONFIRMATION DURING SURGERY ENSURED ALL FRAGMENTS WERE RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED. THERE WAS NO INJURY TO THE PATIENT, NOR HAVE THERE BEEN ANY POST-SURGICAL COMPLICATIONS OR PATIENT READMISSIONS RELATED TO THE RETAINED FOREIGN OBJECT. BOTH THE INSTRUMENT AND THE FRAGMENT ARE AVAILABLE AND WILL BE RETURNED TO ISI FOR EVALUATION." }, { "mdr_text_key": "404505475", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "404505476", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: G3, G6, H2, H3, H6, AND H11 DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A CLAMP ARM TEFLON PAD DAMAGE. THE TEFLON PAD WAS FOUND DETACHED FROM THE ARM CLAMP. THE TEFLON PAD WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THE DAMAGED TEFLON PAD DID NOT SHOW DAMAGE." }, { "mdr_text_key": "398990661", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "398990662", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "IT IS UNCLEAR IF A CORRECT INSTRUMENT WAS RETURNED AND REPORTED UNDER MRF2955842-2026-20362 AND IF FAILURE ANALYSIS IS RELATED TO THE EVENT ON THIS REPORT: INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A HARMONIC ACE INSTRUMENT (L12241031 0074) TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN BLADE AT THE BASE. A PIECE APPROXIMATELY 10.0 MM X 2.1 MM WAS FOUND TO BE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT. COMPONENTS ADJACENT TO THIS BROKEN BLADE DID NOT SHOW DAMAGE. THE INSTRUMENT WAS FOUND TO HAVE A GENERATOR SELF-TEST (INITIALIZATION) FAILURE DURING IN-HOUSE TESTING. SELF-TEST FAILED CONSISTENTLY ON MULTIPLE ATTEMPTS. THE GENERATOR DISPLAYED AN ERROR MESSAGE INDICATING \"TIGHTEN ASSEMBLY\", EVEN THOUGH THE ASSEMBLY WAS ALREADY TIGHTENED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/13/2026;06/12/2026" } ] }