{
  "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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          "udi_public": "(01)10886874112738(17)260131(10)L80240201",
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      "manufacturer_contact_country": "US",
      "date_changed": "20250820",
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            "DA VINCI INSTRUMENTS AND ACCESSORIES"
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          "patient_ethnicity": "",
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          "patient_problems": [
            "Foreign Body In Patient",
            "Foreign Body In Patient"
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        }
      ],
      "distributor_city": "",
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      "initial_report_to_fda": "",
      "distributor_state": "",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "19324118",
      "removal_correction_number": "N/A",
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      "date_manufacturer_received": "20240417",
      "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",
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      "manufacturer_state": "",
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      "single_use_flag": "Y",
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      "mdr_text": [
        {
          "mdr_text_key": "342569987",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE HARMONIC ACE INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS TEAM. THE REPORTED FAILURE WAS CONFIRMED AND REPLICATED. THE GRIP PIN WAS STILL INTACT AND THROUGH THE GRIP, IN ITS ORIGINAL POSITION. HOWEVER, A PIECE WAS BROKEN OFF OF THE GRIP PIN. THE MISSING PIECE WAS NOT RETUNED WITH THE INSTRUMENT."
        },
        {
          "mdr_text_key": "342569988",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT STOPPED WORKING. A PIECE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURIGN THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY."
        }
      ],
      "number_patients_in_event": "",
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      "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": ""
    }
  ]
}