{
  "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": "2026-10-13",
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          "manufacturer_d_address_1": "3410 Central Expressway",
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          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
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            "da Vinci Instruments and Accessories."
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "Santa Clara",
      "mdr_report_key": "50505977",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260806",
      "manufacturer_name": "",
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      "remedial_action": [
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      "manufacturer_g1_name": "INTUITIVE SURGICAL, INC",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
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      "mdr_text": [
        {
          "mdr_text_key": "15603607706",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "It was reported that during a da Vinci-assisted liver resection procedure, the Harmonic Ace blade tip fractured and a fragment fell into the patient. The fragments were retrieved during the same procedure under direct endoscopic visualization using laparoscopic instruments, with full retrieval confirmed by the circulating nurse. No post-operative imaging, such as an X-ray or ultrasound, was performed to check for remaining fragments, and no patient injury was reported."
        },
        {
          "mdr_text_key": "16103607714",
          "text_type_code": "Additional Manufacturer Narrative",
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          "text": "The Harmonic Ace instrument has not been received for failure analysis evaluation."
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      "manufacturer_g1_address_1": "3410 Central Expressway",
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      "manufacturer_contact_postal_code": "95051",
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      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}