{
  "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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      "report_to_fda": "",
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      "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY",
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      "reprocessed_and_reused_flag": "N",
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      "manufacturer_contact_country": "US",
      "date_changed": "20250822",
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            "Foreign Body In Patient"
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      "date_report": "20241112",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "20881395",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
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      "manufacturer_name": "",
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      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "95051",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "INTUITIVE SURGICAL, INC",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "single_use_flag": "Y",
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      "mdr_text": [
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          "mdr_text_key": "358661216",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "NO PRODUCT HAS BEEN RETURNED. A REVIEW OF AN IMAGE PROVIDED BY THE CUSTOMER OF THE HARMONIC ACE INSTRUMENT WAS CONDUCTED. THE IMAGE APPEARS TO SHOW THE TEFLON PAD BROKEN OFF FROM THE INSTRUMENT."
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          "mdr_text_key": "358661217",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED A VOLUNTARY MEDWATCH REPORT (MDR) WITH THE FOLLOWING EVENT DESCRIPTION: \"DURING THE SURGERY, A PIECE OF THE ROBOTIC HARMONIC SHEARS BROKE OFF. IT OCCURRED WHILE THE SURGEON WAS CAUTERIZING THE TISSUE WITH THE SHEARS. THE BROKEN PIECE WAS RECOVERED.\""
        }
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      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "95051",
      "manufacturer_contact_exchange": "408",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}