{
  "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",
    "results": {
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    {
      "manufacturer_contact_zip_ext": "",
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      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2955842-2013-04889",
      "type_of_report": [
        "Initial submission"
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      "product_problem_flag": "N",
      "date_received": "20131101",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K050369",
      "date_of_event": "20090909",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20131104",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "562521",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20131101",
          "brand_name": "DA VINCI S SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL,INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "IS2000",
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          "lot_number": "",
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          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
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      ],
      "reporter_state_code": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20131101",
          "sequence_number_treatment": [
            "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES"
          ],
          "sequence_number_outcome": [
            "Hospitalization",
            " R"
          ],
          "patient_age": "45 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hemorrhage/Blood Loss/Bleeding",
            "Renal Failure",
            "Tissue Damage"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20131004",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3443383",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20131004",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3900172",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "AS PART OF A LEGAL DISPUTE, INTUITIVE SURGICAL RECEIVED INFORMATION REGARDING A PATIENT WHO UNDERWENT A DA VINCI ROBOTIC MITRAL VALVE REPAIR ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. THERE WAS A REPORT OF AN INTRAOPERATIVE COMPLICATION, NAMELY HEMOPERITONEUM SECONDARY TO TRAUMA TO THE LIVER. IT IS SUSPECTED THAT PRESSURE FROM ONE OF THE ROBOTIC ARMS MAY HAVE EXCEEDED THE LIVER CAPSULES BURST PRESSURE AND A SMALL SECTION OF THE LIVER'S RIGHT LOBE OPENED ALLOWING BLEEDING TO OCCUR INTO THE ABDOMINAL CAVITY. THIS WAS HAPPENING WHILE THE ROBOTIC VALVE REPLACEMENT WAS ONGOING. HEMODYNAMIC CONCERNS DEVELOPED, THE HEMOPERITONEUM WAS RECOGNIZED AND THE ABDOMEN WAS OPENED AND THE LIVER WAS REPAIRED. CONSEQUENTLY THE PATIENT DEVELOPED SYMPTOMS OF ACUTE RENAL FAILURE AND REQUIRED HEMODIALYSIS. NO FURTHER CLINICAL INFORMATION WAS PROVIDED."
        },
        {
          "mdr_text_key": "11243018",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL HAS NOT DETERMINED THE ROOT CAUSE OF THE POST- SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE OPERATIVE REPORT INDICATED THAT AFTER UNDERGOING A DA VINCI SURGICAL PROCEDURE THE PATIENT SUFFERED POST -SURGICAL COMPLICATIONS."
        }
      ],
      "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": ""
    }
  ]
}