{
  "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",
      "manufacturer_contact_pcity": "40852321",
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      "date_of_event": "20240809",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "95051",
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      "manufacturer_g1_postal_code": "95051",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
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          "generic_name": "PATIENT SIDE CART",
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          "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SANTA CLARA",
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          "device_evaluated_by_manufacturer": "N",
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          "udi_public": "(01)00886874114605",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250724",
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          "patient_sex": "Female",
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          "patient_ethnicity": "Non Hispanic",
          "patient_race": "Black Or African American",
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            "Hematoma"
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        }
      ],
      "distributor_city": "",
      "date_report": "20240812",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "SANTA CLARA",
      "mdr_report_key": "20124919",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20240812",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
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      "mdr_text": [
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          "mdr_text_key": "350780250",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS WERE NOT AVAILABLE."
        },
        {
          "mdr_text_key": "350780251",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED AFTER A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY PROCEDURE, THE PATIENT EXPERIENCED AN EXPANDING RIGHT BREAST HEMATOMA AND REQUIRED RE-OPERATION THE SAME DAY. THE RE-OPERATION INCLUDED A RIGHT BREAST RE-EXPLORATION, WASHOUT, AND TISSUE EXPANDER IMPLANT PLACEMENT AND UPSIZE. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY ONE WITHOUT COMPLICATIONS."
        }
      ],
      "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": ""
    }
  ]
}