{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "HOSPITAL",
      "report_to_fda": "N",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Malfunction",
      "report_number": "2210968-2008-00092",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20080221",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K993801",
      "date_of_event": "20080121",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "report_date": "20080122",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "Foreign",
        "Health Professional",
        "User facility",
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20080121",
      "manufacturer_g1_state": "",
      "reporter_country_code": "KS",
      "manufacturer_contact_area_code": "",
      "date_added": "20080418",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20080221",
          "brand_name": "GYNECARE X-TRACT MORCELLATOR",
          "generic_name": "LAPAROSCOPIC MORCELLATOR",
          "manufacturer_d_name": "ETHICON, INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SOMERVILLE",
          "manufacturer_d_state": "NJ",
          "manufacturer_d_zip_code": "08876",
          "manufacturer_d_zip_code_ext": "015",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "08876 0151",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "NA",
          "catalog_number": "MD0100",
          "lot_number": "NA",
          "other_id_number": "NA",
          "device_availability": "Yes",
          "date_returned_to_manufacturer": "20080213",
          "device_report_product_code": "HET",
          "device_age_text": "NA",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Laparoscope, Gynecologic (And Accessories)",
            "medical_specialty_description": "Obstetrics/Gynecology",
            "regulation_number": "884.1720",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Other (for use when an appropriate device code cannot be identified)"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250808",
      "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": "20080221",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "UNK",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20080122",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1000674",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080122",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "781471",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC MYOMECTOMY IN 2008. WHILE ATTEMPTING TO CONNECT THE HAND PIECE TO THE MOTOR DRIVE UNIT, THE CPC CONNECTOR BROKE AWAY FROM THE MOTOR DRIVE UNIT. THIS OCCURRED BEFORE USE ON THE PT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY CUTTING THE MYOMA WITH SCISSORS INSIDE THE PELVIC CAVITY WITH NO ADVERSE PT CONSEQUENCES."
        },
        {
          "mdr_text_key": "7935712",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DAMAGE TO DRIVE CONNECTOR/COUPLING. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}