{ "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": "2955842-2025-13026", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250407", "manufacturer_address_2": "", "pma_pmn_number": "K112584", "date_of_event": "20240419", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "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": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "408", "date_added": "20250407", "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": "886140", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250407", "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": "400272-03", "catalog_number": "400272", "lot_number": "L10230126", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "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": "08/14/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251020", "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": "20250407", "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": "20250313", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21785014", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250313", "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": "382923572", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 14-AUG-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE FRAGMENT FALLING INSIDE OF THE PATIENT WAS CUTTING. THE SURGEON BELIEVED THAT THE CAUSE OF THE ISSUE WAS RELATED TO PRODUCT QUALITY. THE INSTRUMENT WAS IN USE FOR 10 MINUTES ONLY WHEN THE ISSUE WAS IDENTIFIED. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT DURING THE SURGICAL PROCEDURE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE PROCEDURE. THE INSTRUMENT WAS NOT REMOVED DURING THE SURGICAL PROCEDURE, PRIOR TO THE BREAKAGE. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVING THE INSTRUMENT THROUGH THE CANNULA. DURING THE FINAL REMOVAL OF THE INSTRUMENT THE WRIST WAS STRAIGHTENED AND NO RESISTANCE NOTED. THERE WAS NO DAMAGE SEEN ON THE INSTRUMENT, OR THE CANNULA AFTER THE EVENT. THE FRAGMENTS WERE SEEN ON THE SCREEN AND WERE RETRIEVED. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENTS. THE CUSTOMER PERFORMED AN ULTRASOUND TO CONFIRM THAT NO FRAGMENTS WERE LEFT BEHIND. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURIES TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND A FRAGMENT ARE AVAILABLE FOR RETURN. THERE ARE NO PHOTOGRAPHIC IMAGES OF THE DEVICE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "382923573", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "367568313", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A RETURN MATERIAL AUTHORIZATION (RMA) HAD BEEN ISSUED REQUESTING TO HAVE THE ISI DEVICE RETURNED; HOWEVER, ISI DID NOT RECEIVE THE RMA TO CONFIRM/IDENTIFY THE FAILURE MODE. ALTHOUGH THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE PRODUCT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE PROVIDED IMAGE(S) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: A BROKEN CURVED BLADE WAS NOTED." }, { "mdr_text_key": "367568314", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IN THE PROCESS OF USING DETECTION, THE HARMONIC ACE INSTRUMENT HEAD BROKE. THE CUSTOMER CONFIRMED THAT THE FRACTURED PART WAS COMPLETELY REMOVED, AND NO FRAGMENT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED." } ], "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": "08/26/2025" } ] }