{
  "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/",
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      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
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          "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 THAT UNDERWENT A DA VINCI HYSTERECTOMY PROCEDURE ON (B)(6) 2008. THE LEGAL COMPLAINT ALLEGED THAT THE PATIENT SUFFERED FROM SEVERE AND CONTINUING PAIN, WITH FREQUENT VISITS TO THE EMERGENCY ROOMS OF NEARBY HOSPITALS. IN ADDITION, ACCORDING TO THE LEGAL COMPLAINT, THE PATIENT'S SEVERE PAIN BECAME INCREASINGLY UNBEARABLE AND SHE UNDERWENT AN ADDITIONAL SURGERY IN (B)(6) 2009. DURING THE ADDITIONAL SURGERY, THE LEGAL COMPLAINT CLAIMED THAT THE PATIENT WAS FOUND TO HAVE DENSE ADHESIONS BETWEEN THE RIGHT ADNEXA AND THE BOWEL. THE LEGAL COMPLAINT ALSO INDICATED THAT AFTER THE ADNEXA WAS REMOVED, THE APPENDIX WAS REMOVED TO DO A COMPLETE PAIN CLEAN UP OF THE RIGHT SIDE OF THE PELVIS."
        },
        {
          "mdr_text_key": "11166145",
          "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 POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. NO PREVIOUS COMPLAINT WAS REPORTED RELATING TO THIS EVENT. THE HOSPITAL NAME, SURGEON NAME, AND SYSTEM SERIAL INVOLVED WITH THIS LEGAL COMPLAINT WERE NOT PROVIDED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT'S ATTORNEY ALLEGED THAT THE PATIENT DEVELOPED POST-OPERATIVE COMPLICATIONS AND REQUIRED ADDITIONAL MEDICAL INTERVENTION AFTER UNDERGOING A DA VINCI HYSTERECTOMY PROCEDURE. HOWEVER, AT THIS TIME, IT IS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE PATIENT'S POST-OPERATIVE COMPLICATIONS."
        }
      ],
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      "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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}