{
  "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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      "pma_pmn_number": "K081137",
      "date_of_event": "20110930",
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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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      "date_changed": "20250826",
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          "date_received": "20131025",
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      "date_report": "20130927",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3430580",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20130927",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "mdr_text": [
        {
          "mdr_text_key": "15468131",
          "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 FOR THE OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. ON (B)(4) 2013, ISI CONTACTED THE DIRECTOR OF RISK MANAGEMENT AT THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE DIRECTOR, AN INTERNAL INVESTIGATION WAS PERFORMED AT THE SITE REGARDING THE REPORTED EVENT AND NO EVIDENCE OF A MALFUNCTION OF THE DA VINCI SI SURGICAL SYSTEM WAS FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THE DIRECTOR INDICATED THAT HE COULD NOT DISCLOSE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2011. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE PLANNED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S ATTORNEY ALLEGED THAT THE PATIENT SUSTAINED A PUNCTURED COLON. HOWEVER, AT THIS TIME, IT IS UNKNOWN HOW THE PATIENT'S INJURY OCCURRED."
        },
        {
          "mdr_text_key": "15098974",
          "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 SI PROSTATECTOMY PROCEDURE ON (B)(6) 2011. ACCORDING TO THE LEGAL DOCUMENT, THE PATIENT WAS REPORTED TO HAVE SUSTAINED A PUNCTURED COLON INJURY."
        }
      ],
      "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": ""
    }
  ]
}