{
  "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/",
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    "last_updated": "2026-09-08",
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      "reporter_occupation_code": "RISK MANAGER",
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          "date_removed_year": "",
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          "date_received": "20130809",
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            "device_name": "System, Surgical, Computer Controlled Instrument",
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            "regulation_number": "876.1500",
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          "implant_flag": "",
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          "device_sequence_number": "381774",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20130809",
          "brand_name": "DA VINCI ROBOT",
          "generic_name": "PATIENT CART",
          "manufacturer_d_name": "INTUITIVE SURGICAL",
          "manufacturer_d_address_1": "1266 KIFER RD, BLDG 101",
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          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "94085",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "PS3000",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "TRK ID- 262172",
          "device_availability": "Yes",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
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          "udi_public": "",
          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      "reporter_state_code": "LA",
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      "suppl_dates_mfr_received": "",
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      "date_changed": "20250725",
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      "patient": [
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          "patient_sequence_number": "1",
          "date_received": "20130809",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "37 YR",
          "patient_sex": "",
          "patient_weight": "83",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Arrhythmia",
            "Death",
            "Hemorrhage/Blood Loss/Bleeding",
            "Infiltration into Tissue",
            "Left Ventricular Dysfunction",
            "Loss Of Pulse"
          ]
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      ],
      "distributor_city": "",
      "date_report": "20130808",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3289234",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "20233777",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "(B)(6) FEMALE UNDERGOING A ROBOTIC MYOMECTOMY AND BILATERAL NEOSALPINGOSTOMY HAD AN INTRAOPERATIVE DEATH. NEAR THE END OF THE PROCEDURE, THE PT'S BLOOD PRESSURE WAS NOT DETECTED IN THE PRESENCE OF A PULSE AND NORMAL OXYGENATION LEVELS. THE RHYTHM WAS NOTED TO BE PULSELESS ELECTRICAL ACTIVITY (PEA). DESPITE ACLS PROCEDURES AND AN ATTEMPT TO INSERT AN INTRA-AORTIC BALLOON PUMP TO SUSTAIN THE PT, ALL RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL. RESUSCITATIVE EFFORTS WERE SUSTAINED FOR OVER 2 HRS AT NO TIME WAS A PROBLEM WITH THE ROBOTIC EQUIPMENT REPORTED. THIS WAS AN UNEXPECTED DEATH. PROVISIONAL AUTOPSY RESULTS: AV SEPTUM REVEALED AN AREA OF BLEEDING AND FATTY INFILTRATION. THERE WAS FATTY INFILTRATION OF THE LIVER. HOWEVER, IN THE ABSENCE OF OTHER FINDINGS, DEFINITIVE CHARACTERIZATIONS FOR THE CAUSE OF THE ARRHYTHMIA AND LEFT VENTRICULAR FAILURE IS NOT POSSIBLE. THE FINAL RESULTS ARE STILL PENDING."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}