{
  "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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      "event_location": "HOSPITAL",
      "report_to_fda": "",
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      "manufacturer_contact_address_1": "",
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      "report_number": "2955842-2013-03049",
      "type_of_report": [
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      "pma_pmn_number": "K081137",
      "date_of_event": "20130710",
      "reprocessed_and_reused_flag": "N",
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      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_contact_area_code": "",
      "date_added": "20130816",
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          "serviced_by_3rd_party_flag": "",
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          "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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          "device_operator": "HEALTH PROFESSIONAL",
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            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250724",
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      "manufacturer_contact_extension": "",
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        {
          "patient_sequence_number": "1",
          "date_received": "20130815",
          "sequence_number_treatment": [
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          ],
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          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
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            "Death"
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      "date_report": "20130716",
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      "distributor_state": "",
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      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "3290825",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20130716",
      "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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      "manufacturer_state": "",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "21732385",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT DURING A DA VINCI SI NISSEN FUNDOPLICATION PROCEDURE, AFTER THE SURGEON COMPLETED SUTURING, THE PATIENT EXPIRED. REPORTEDLY, THE PATIENT'S DEMISE WAS RELATED TO A PULMONARY EMBOLISM AND THAT THE PATIENT'S DEMISE WAS UNRELATED TO A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS OR ACCESSORIES. IT IS BELIEVED THAT THE PATIENT EXPERIENCED COMPLICATIONS TO BLEEDING. NO OTHER INFORMATION WAS PROVIDED."
        },
        {
          "mdr_text_key": "21903677",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE LIMITED INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT'S DEMISE. SEVERAL ATTEMPTS HAVE BEEN MADE TO VERIFY ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. 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 PATIENT'S DEATH. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE PATIENT EXPIRED DURING A DA VINCI SURGICAL PROCEDURE."
        }
      ],
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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": ""
    }
  ]
}