{
  "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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      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20100618",
      "reprocessed_and_reused_flag": "N",
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      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
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      "manufacturer_contact_area_code": "",
      "date_added": "20131101",
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "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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          "device_operator": "HEALTH PROFESSIONAL",
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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": "20250812",
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      "summary_report_flag": "N",
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          "date_received": "20131031",
          "sequence_number_treatment": [
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          "sequence_number_outcome": [
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          "patient_sex": "",
          "patient_weight": "64",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
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      "date_report": "20131004",
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      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3441217",
      "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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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3945236",
          "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 HYSTERECTOMY, RSO, BILATERAL PELVIC LYMPHADENECTOMY FOR ENDOMETRIAL CANCER ON (B)(6) 2010. INTUITIVE SURGICAL WAS PROVIDED WITH THE OPERATIVE REPORT. ADDITIONAL INFORMATION PROVIDED INCLUDES: MEDICAL RECORDS RELATED TO POST OPERATIVE CARE. THERE WAS NO INDICATION OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENT OR ACCESSORY DURING SURGERY . ON (B)(6) 2010, THE PATIENT PRESENTED TO ER WITH VAGINAL PRESSURE. RETURNED ON (B)(6) 2010 FOR VAGINAL CUFF DEHISCENCE AND SMALL BOWEL EVISCERATION. PATIENT UNDERWENT REPAIR OF VAGINAL CUFF VIA VAGINAL APPROACH AND CYSTOSCOPY. PATIENT WAS PLACED ON RESTRICTIONS AT DISCHARGE. DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2010. PATIENT WAS READMITTED 7/26/201 FOR ILEUS AND DISCHARGED ON (B)(6) 2010. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. (B)(6)"
        },
        {
          "mdr_text_key": "11450811",
          "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": ""
    }
  ]
}