{
  "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": "2026-06-11",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "MS.",
      "manufacturer_contact_state": "CA",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "TUTTLINGEN,",
      "manufacturer_contact_address_1": "2151 E GRAND AVE",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "9610617-2026-00388",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20260226",
      "manufacturer_address_2": "",
      "pma_pmn_number": "EXEMPT",
      "date_of_event": "20260213",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "90245",
      "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "FAIR",
      "source_type": [
        "Foreign",
        "Health Professional",
        "User facility",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "78532",
      "manufacturer_g1_state": "",
      "reporter_country_code": "SP",
      "manufacturer_contact_area_code": "",
      "date_added": "20260226",
      "manufacturer_contact_f_name": "ANJA",
      "previous_use_code": "U",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "350957",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20260226",
          "brand_name": "KARL STORZ OR1 CONTROL NEO",
          "generic_name": "KARL STORZ OR1 CONTROL NEO",
          "manufacturer_d_name": "KARL STORZ SE & CO. KG",
          "manufacturer_d_address_1": "DR.-KARL-STORZ-STRASSE 34",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "TUTTLINGEN,",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "78532",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "GM",
          "manufacturer_d_postal_code": "78532",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "20097120-1",
          "catalog_number": "20097120-1",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "LMD",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "System, Digital Image Communications, Radiological",
            "medical_specialty_description": "Radiology",
            "regulation_number": "892.2020",
            "device_class": "1"
          }
        }
      ],
      "product_problems": [
        "Output Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260519",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20260226",
          "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": "20260226",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "GM",
      "manufacturer_contact_city": "EL SEGUNDO",
      "mdr_report_key": "24461324",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260213",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "78532",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "KARL STORZ SE & CO. KG",
      "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": "395202735",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE FOLLOWING WAS REPORTED: \"THE CUSTOMER REPORTS THAT THE SCB MODULE OF A TOWER FAILED DURING SURGERY. THE IMAGES ON THE MONITORS WERE NOT VISIBLE, AS THE MODULE WAS TURNED OFF AND WOULD NOT POWER ON. HOWEVER, THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED BECAUSE AN AUXILIARY SYSTEM WAS AVAILABLE AND COULD BE USED WITHOUT ANY ISSUES. THERE WAS NO EXTENSION OF THE PROCEDURE TIME. THE AFFECTED."
        },
        {
          "mdr_text_key": "395202736",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED AT THE TIME OF MDR SUBMISSION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4)."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "DR.-KARL-STORZ-STRASSE 34",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "90245",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}