{
  "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": "",
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      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "",
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      "report_number": "2955842-2013-04570",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20131023",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20110503",
      "reprocessed_and_reused_flag": "N",
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      "manufacturer_contact_area_code": "",
      "date_added": "20131024",
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "543654",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20131023",
          "brand_name": "DA VINCI 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": "",
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          "device_operator": "HEALTH PROFESSIONAL",
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250818",
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      "summary_report_flag": "N",
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        {
          "patient_sequence_number": "1",
          "date_received": "20131023",
          "sequence_number_treatment": [
            "DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES"
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          "patient_age": "",
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          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
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      "date_report": "20130923",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3426352",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20130923",
      "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": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3894729",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "AS PART OF A LEGAL DISPUTE INTUITIVE SURGICAL, INC. (ISI) RECEIVED INFORMATION REGARDING A PATIENT THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2011. THE LEGAL DOCUMENT ALLEGES THAT THE PATIENT SUSTAINED A LEFT URETER CAUTERY INJURY DURING THE PROCEDURE. THE REPORTED INJURY PREVENTED A SUCCESSFUL POST-OPERATIVE STENT AND THE PATIENT WAS REQUIRED TO UNDERGO AN URETERAL REIMPLANTATION ON AN UNSPECIFIED DATE. DETAILS REGARDING THE EVENTS LEADING TO THE PATIENT'S REPORTED INJURIES WERE NOT REPORTED. THE LEGAL DOCUMENT PROVIDES A DA VINCI SYSTEM SERIAL ; HOWEVER, THE SYSTEM SERIAL IS INCORRECT SINCE THE SYSTEM SERIAL IS NOT ASSOCIATED WITH THE REPORTED SITE'S NAME. AT THIS TIME, THE SYSTEM SERIAL ASSOCIATED WITH THE REPORTED PROCEDURE CANNOT BE CONFIRMED. ISI ATTEMPTED TO CONTACT THE SITE'S RISK MANAGEMENT GROUP TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT."
        },
        {
          "mdr_text_key": "11395522",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-SURGICAL COMPLICATIONS EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPERIENCED INTRA-SURGICAL COMPLICATIONS DURING UNDERGOING A DA VINCI SURGICAL HYSTERECTOMY PROCEDURE."
        }
      ],
      "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": ""
    }
  ]
}