{
  "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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      "type_of_report": [
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      "pma_pmn_number": "K081137",
      "date_of_event": "20090521",
      "reprocessed_and_reused_flag": "N",
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      "manufacturer_g1_state": "",
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      "date_added": "20131031",
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          "date_received": "20131031",
          "brand_name": "DA VINCI SI 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",
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          "manufacturer_d_zip_code_ext": "",
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            "medical_specialty_description": "Gastroenterology, Urology",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
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      "date_changed": "20250813",
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      "summary_report_flag": "N",
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          "patient_sequence_number": "1",
          "date_received": "20131031",
          "sequence_number_treatment": [
            "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES&ES"
          ],
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          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
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      "date_report": "20131002",
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      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3439965",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20131002",
      "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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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3945195",
          "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 ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC AND PERIAORTIC LYMPH NODE DISSECTION ON (B)(6) 2009. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. 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. URETEROLYSIS WAS PERFORMED; THE URETERS WERE UNROOFED USING BIPOLAR AND MONOPOLAR ENERGIES. CARE WAS TAKEN NOT TO INJURE THE URETERS. ON (B)(6) 2009, THE PATIENT PRESENTED WITH A SUSPECTED VESICOVAGINAL FISTULA. SHE UNDERWENT AN EXTENSIVE ADHESIOLYSIS, RIGHT URETEROLYSIS AND RIGHT URETERONEOCYSTOSTOMY WITH REPAIR OF VAGINAL FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED AFTER THE DATE OF DISCHARGE."
        },
        {
          "mdr_text_key": "11100032",
          "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": ""
    }
  ]
}