{
  "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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      "event_location": "HOSPITAL",
      "report_to_fda": "",
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      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2955842-2013-04770",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20131031",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K050369",
      "date_of_event": "20080606",
      "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_contact_l_name": "",
      "source_type": [
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20131031",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "559572",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20131031",
          "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 A5.1P8",
          "catalog_number": "",
          "lot_number": "",
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          "device_evaluated_by_manufacturer": "",
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          "udi_di": "",
          "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": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250818",
      "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": "20131031",
          "sequence_number_treatment": [
            "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES&ESU"
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "62 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20131004",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3440132",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3857401",
          "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 PROSTATECTOMY FOR PROSTATE CANCER PROCEDURE ON (B)(6) 2008. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES FOLLOW UP OPERATIVE REPORTS AND NOTES THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY. THERE WAS NO REPORT OF AN INTRAOPERATIVE COMPLICATION. ON (B)(6) 2013, IT WAS NOTED THAT THE PATIENT'S FOLEY CATHETER WAS NOT DRAINING WELL. THE PATIENT RETURNED TO SURGERY FOR EXPLORATION OF BLADDER AND PELVIS WITH RECONSTRUCTION OF BLADDER NECK AND RE-ANASTAMOSIS OF BLADDER NECK. PATIENT WAS DISCHARGED HOME ON (B)(6) 2008. NO FURTHER CLINICAL INFORMATION WAS PROVIDED."
        },
        {
          "mdr_text_key": "11394372",
          "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": ""
    }
  ]
}