{
  "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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      "date_of_event": "20120828",
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          "brand_name": "DA VINCI SI SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL,INC.",
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          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3375119",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20130829",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
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      "manufacturer_g1_zip_code": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3928672",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2013, INTUITIVE SURGICAL, INC. (ISI) RECEIVED A LEGAL COMPLAINT REGARDING A PATIENT WHO UNDERWENT A DA VINCI SI HYSTERECTOMY PROCEDURE ON (B)(6) 2012. ACCORDING TO THE INFORMATION PROVIDED IN THE LEGAL COMPLAINT, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012. REPORTEDLY, ON (B)(6) 2012, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF CONTINUED URINE LEAKAGE. THE PATIENT UNDERWENT TESTING THAT SHOWED THAT THE PATIENT HAD SUSTAINED A RIGHT URETERAL INJURY AND AS A RESULT THE PATIENT HAD TO UNDERGO A NEPHROSTOMY PROCEDURE."
        },
        {
          "mdr_text_key": "11111779",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INJURY SUSTAINED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA. ISI HAS CONTACTED RISK MANAGEMENT GROUP AT THE SITE TO GATHER ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE FOUND THAT NO SYSTEM ERRORS WERE GENERATED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INJURY SUSTAINED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT SUSTAINED A BLADDER INJURY DURING A DA VINCI SI 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": ""
    }
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}