{
  "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",
    "results": {
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      "manufacturer_contact_zip_ext": "",
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      "manufacturer_contact_t_name": "",
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      "manufacturer_contact_address_2": "",
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      "manufacturer_contact_address_1": "",
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      "type_of_report": [
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      "manufacturer_address_2": "",
      "pma_pmn_number": "",
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      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "RISK MANAGER",
      "manufacturer_contact_plocal": "",
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      "reporter_country_code": "US",
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      "date_added": "20151110",
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20151028",
          "brand_name": "DA VINCI MONOPOLAR CURVED SCISSORS 8MM",
          "generic_name": "DA VINCI ROBOTIC SCISSORS",
          "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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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
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          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "42017 VER-15",
          "catalog_number": "NA",
          "lot_number": "N10150904 738",
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          "device_availability": "Device was returned to manufacturer",
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          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
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        "Fracture",
        "Material Integrity Problem"
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      "reporter_state_code": "NC",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250811",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "date_received": "20151028",
          "sequence_number_treatment": [
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          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "54 YR",
          "patient_sex": "",
          "patient_weight": "87",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available"
          ]
        }
      ],
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      "date_report": "20151027",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "20151027",
      "manufacturer_contact_city": "",
      "mdr_report_key": "5213381",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "20151027",
      "manufacturer_name": "",
      "report_source_code": "User Facility report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "30976131",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE PT IS A (B)(6) MALE ADMITTED TO THE MEDICAL CENTER ON (B)(6) 2015 WITH PRIMARY DIAGNOSIS OF PROSTATE CANCER. THE PT WAS UNDERGOING ROBOTIC ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY ON (B)(6) 2015. ABOUT FIVE MINUTES INTO THE ROBOTIC PORTION OF THE SURGERY THE CHIEF RESIDENT NOTICED A FOREIGN BLACK OBJECT INSIDE OF THE PT'S BODY. THE FOREIGN BODY WAS RETRIEVED AND EXAMINED. THE PIECE TURNED OUT TO BE A SMALL BLACK BAND THAT CAME OFF OF THE MONOPOLAR CURVED SCISSORS. THE BLACK BAND CAME OFF THE DISTAL PORTION OF THE SCISSORS SHAFT IN A SECTION JUST ABOVE THE INSULATED SLEEVE. THE BLACK BAND HAD A UNEVEN FRACTURE IN THE MATERIAL. THIS WAS THE FIRST TIME THE SCISSORS HAD BEEN USED."
        }
      ],
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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": ""
    }
  ]
}