{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MR.",
      "manufacturer_contact_state": "MA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "AIZUWAKAMATSU-SHI, FUKUSHIMA",
      "manufacturer_contact_address_1": "800 WEST PARK DRIVE",
      "manufacturer_contact_pcity": "50820776",
      "event_type": "Malfunction",
      "report_number": "9610595-2026-45135",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20260603",
      "manufacturer_address_2": "",
      "pma_pmn_number": "N/A",
      "date_of_event": "20260508",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "01581",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "5082077661",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "BRILL",
      "source_type": [
        "Foreign",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "965-8520",
      "manufacturer_g1_state": "",
      "reporter_country_code": "JA",
      "manufacturer_contact_area_code": "",
      "date_added": "20260603",
      "manufacturer_contact_f_name": "TODD",
      "device_date_of_manufacturer": "20071101",
      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1435584",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20260603",
          "brand_name": "EVIS LUCERA DUODENOVIDEOSCOPE",
          "generic_name": "DUODENOVIDEOSCOPE",
          "manufacturer_d_name": "AIZU OLYMPUS CO., LTD.",
          "manufacturer_d_address_1": "3-1-1 NIIDERAKITA",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "AIZUWAKAMATSU-SHI, FUKUSHIMA",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "965-8",
          "manufacturer_d_zip_code_ext": "520",
          "manufacturer_d_country": "JA",
          "manufacturer_d_postal_code": "965-8520",
          "device_operator": "OTHER",
          "model_number": "TJF-260V",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20260511",
          "device_report_product_code": "FDT",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Duodenoscope And Accessories, Flexible/Rigid",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Failure to Clean Adequately"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20260715",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "520",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20260603",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260603",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "JA",
      "manufacturer_contact_city": "WESTBOROUGH",
      "mdr_report_key": "25371897",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260602",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "965-8",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "AIZU OLYMPUS CO., LTD.",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "403125528",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE."
        },
        {
          "mdr_text_key": "403125529",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE CUSTOMER RETURNED THE DUODENOVIDEOSCOPE TO THE SERVICE CENTER FOR AN INSTRUMENT CANNOT BE REMOVED FROM THE BIOPSY CHANNEL. DURING THE DEVICE ANALYSIS, A FOREIGN MATERIAL STUCK IN THE FORCEPS CHANNEL WAS FOUND.  THERE WAS NO PATIENT INVOLVEMENT."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "3-1-1 NIIDERAKITA",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "01581",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}