{
  "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": "2026-10-13",
    "results": {
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      "limit": 1,
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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "HAKIDMA",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "MN",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "BUILDING C",
      "manufacturer_g1_city": "YOKNEAM",
      "manufacturer_contact_address_1": "4100 HAMLINE AVENUE NORTH",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "2124215-2023-64528",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20231115",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20231026",
      "reprocessed_and_reused_flag": "",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "55112",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "FAHIMI",
      "source_type": [
        "Health Professional"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20231116",
      "manufacturer_contact_f_name": "FARSHAD",
      "device_date_of_manufacturer": "20220612",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "234663",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20231115",
          "brand_name": "ULTRAPULSE DUO",
          "generic_name": "POWERED LASER SURGICAL INSTRUMENT",
          "manufacturer_d_name": "LUMENIS LTD",
          "manufacturer_d_address_1": "HAKIDMA 6",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "YOKNEAM",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "20692",
          "manufacturer_d_zip_code_ext": "04",
          "manufacturer_d_country": "IS",
          "manufacturer_d_postal_code": "2069204",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "GA-2000000",
          "catalog_number": "GA-2000000",
          "lot_number": "0000000266",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "GEX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "R",
          "combination_product_flag": "N",
          "udi_di": "07290109140322",
          "udi_public": "07290109140322",
          "openfda": {
            "device_name": "Powered Laser Surgical Instrument",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4810",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Failure to Align",
        "Defective Device",
        "Failure to Align",
        "Defective Device"
      ],
      "reporter_state_code": "IL",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "US",
      "date_changed": "20250729",
      "health_professional": "",
      "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": "20231115",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20231115",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "IS",
      "manufacturer_contact_city": "SAINT PAUL",
      "mdr_report_key": "18145796",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20231026",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "LUMENIS 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": "328247239",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE FIELD SERVICE ENGINEER CHECKED THE CONSOLE IN THE HEALTH CARE FACILITY. IT WAS NOTICED THAT THE MOUNTING BRACKET BINDING AND MIRROR LOCKING HAD A SCREW MISSING ON ONE SIDE, THEREFORE THE ALLEGATION WAS CONFIRMED. ADDITIONALLY, THE MIRROR AND BRACKET WERE ALIGNED AND THE MIRROR WAS CLEANED. THE DAMAGED MICROMANIPULATOR COULD HAVE AFFECTED THE DEVICE PERFORMANCE LEADING TO THE EVENT EXPERIENCED BY THE CUSTOMER. SINCE AN EXPECTED OR RANDOM COMPONENT FAILURE WAS IDENTIFIED WITHOUT ANY DESIGN OR MANUFACTURING ISSUE, THE INVESTIGATION CONCLUSION CODE SELECTED FOR THIS COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE."
        },
        {
          "mdr_text_key": "328247240",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT THE MICROMANIPULATOR IS NOT WORKING. THE BEAM DIRECTION IS OFF AND NEEDS CALIBRATION, THE LASER LIGHT IS FAINT, AND MIRROR IS LOOSE. NO PATIENT INVOLVEMENT WAS REPORTED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "YOKNEAM INDUSTRIAL PARK",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "55112",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}