{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
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      "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY",
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        "Initial submission"
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K143132",
      "date_of_event": "20250212",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
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      "manufacturer_contact_l_name": "NIELSON",
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      "manufacturer_g1_postal_code": "95051",
      "manufacturer_g1_state": "CA",
      "reporter_country_code": "US",
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      "manufacturer_contact_f_name": "IZABEL",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20250312",
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          "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",
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          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
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          "udi_di": "10886874112738",
          "udi_public": "(01)10886874112738(17)240630(10)L10220608",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
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        "Material Fragmentation",
        "Material Fragmentation"
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      "reporter_state_code": "OH",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250825",
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      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "4085",
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          "patient_sequence_number": "1",
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            "DA VINCI INSTRUMENTS AND ACCESSORIES"
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            "Required Intervention"
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          "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": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "21588016",
      "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",
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      "mdr_text": [
        {
          "mdr_text_key": "365611860",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A CHIPPED CLAMP ARM AT THE DISTAL END. THE CLAMP ARM WAS CHIPPED CAUSING A PIECE OF BROKEN MATERIAL TO COME OFF. THERE WERE PIECES FOUND MISSING."
        },
        {
          "mdr_text_key": "365611861",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE AND A PIECE OF THE INSTRUMENT FELL INSIDE THE PATIENT. THE CUSTOMER RETRIEVED THE FRAGMENT USING A ROBOTIC GRASPER DURING THE SAME SURGICAL PROCEDURE."
        }
      ],
      "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": ""
    }
  ]
}