{ "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": "2955842-2026-23226", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260430", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20260316", "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_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "", "date_added": "20260430", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250908", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1100270", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260430", "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": "480275-12", "catalog_number": "480275", "lot_number": "K11250908", "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": "10886874112738", "udi_public": "(01)10886874112738(10)K11250908", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/12/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260720", "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": "20260430", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention", " O" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260526", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "25046370", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260410", "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": "399975604", "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": "399975605", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, A SMALL PIECE OF THE WHITE CERAMIC PROTECTIVE COATING ON THE JAWS OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THIS PIECE, A FEW MILLIMETERS IN SIZE, ENDED UP IN THE PATIENT'S ABDOMEN. AS THE FORCEPS WERE STILL FUNCTIONING CORRECTLY, THEY WERE RETAINED FOR THE REMAINDER OF THE PROCEDURE. IT WAS UNKNOWN IF THE FRAGMENT WAS RETRIEVED." }, { "mdr_text_key": "403360094", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE HARMONIC ACE INSTRUMENT WAS INSPECTED BEFORE USE AND SHOWED NO VISIBLE DEFECTS. DURING A SURGICAL PROCEDURE, AN INSTRUMENT FRAGMENT FELL INTO THE PATIENT, THOUGH THE SURGEON COULD NOT EXPLAIN WHY AND NOTED NO OPERATIONAL ISSUES OR COMPLAINTS. WHILE MINOR INSTRUMENT COLLISIONS SOMETIMES HAPPEN, IT¿S UNCLEAR IF THIS CAUSED THE BREAK. THE FRAGMENT WAS RETRIEVED USING LAPAROSCOPIC FORCEPS THROUGH AN AUXILIARY TROCAR, AND ITS COMPLETE REMOVAL WAS CONFIRMED BY ALIGNING IT WITH THE MISSING PART OF THE INSTRUMENT. NO EXTRA SURGERY OR POSTOPERATIVE IMAGING WAS NECESSARY. THE PROCEDURE WAS COMPLETED AS PLANNED WITHOUT PATIENT INJURY OR REPORTED COMPLICATIONS. THE INSTRUMENT AND FRAGMENT WERE RETURNED TO THE STERILIZATION DEPARTMENT, AND NO PHOTOS OR VIDEOS ARE AVAILABLE FOR REVIEW." }, { "mdr_text_key": "403360095", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "05/26/2026" } ] }