{ "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": "2955842-2022-13061", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220720", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20220511", "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", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "", "manufacturer_contact_area_code": "408", "date_added": "20220720", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20201022", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "284577", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220720", "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": "M90201025", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "10886874112738", "udi_public": "(01)10886874112738(17)221031(10)M90201025", "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": "", "date_changed": "20250808", "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": "20220720", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "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": "20220621", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "15070908", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20220621", "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": "296290435", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE COULD NOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROCEDURE LOGS CONFIRMS THE OCCURRENCE OF A PROCEDURE ON THE REPORTED EVENT DATE OF (B)(6) 2022 USING SYSTEM SK4413. A REVIEW OF THE SUBMITTED IMAGE WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) REGULATORY POST MARKET SURVEILLANCE (RPMS) ANALYST. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE IMAGE OF THE HARMONIC ACE INSTRUMENT IDENTIFIES A BROKEN INSTRUMENT BLADE. NO CONCLUSIVE DETERMINATION CAN BE MADE BASED ON THIS ANALYSIS. THIS COMPLAINT IS CONSIDERED AS AN ADVERSE EVENT AND MALFUNCTION BASED ON THE FOLLOWING CONCLUSION: THE COMPLAINT ACKNOWLEDGES THAT A FRAGMENT OF THE INTUITIVE PRODUCT FELL INSIDE THE PATIENT DURING A SURGICAL PROCEDURE BUT WAS LOCATED AND RETRIEVED DURING THE SAME PROCEDURE AT THIS TIME, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE REMAINS UNKNOWN." }, { "mdr_text_key": "296290436", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE HARMONIC ACE INSTRUMENT TIP BROKE DURING INTRAOPERATIVE USE. AS A RESULT, A FRAGMENT FELL INSIDE THE PATIENT. THE BROKEN PIECE WAS RETAINED. THE USER COMPLETED THE PROCEDURE USING THE BACKUP INSTRUMENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO DAMAGE OR ANY ABNORMALITY WAS FOUND. APPROXIMATELY AN HOUR WHEN TISSUE DISSECTION WAS BEING PERFORMED WHEN THE PIECE OF THE INSTRUMENT BROKE AND FELL INSIDE THE PATIENT. THE ENTIRE FALLEN PIECE WAS RETRIEVED USING ANOTHER INSTRUMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND REQUIRED. NO POST-SURGICAL COMPLICATIONS REPORTED." } ], "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": "" } ] }