{
  "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": "",
      "manufacturer_contact_state": "",
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      "product_problem_flag": "Y",
      "date_received": "20220705",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20220623",
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      "reporter_occupation_code": "RISK MANAGER",
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      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20220707",
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      "device": [
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20220705",
          "brand_name": "TIP COVER ACCESSORY DA VINCI ROBOT XI",
          "generic_name": "SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT",
          "manufacturer_d_name": "INTUITIVE SURGICAL, INC.",
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          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "expiration_date_of_device": "20240229",
          "model_number": "400180",
          "catalog_number": "",
          "lot_number": "M90220222",
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          "device_availability": "Yes",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
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          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
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      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250807",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
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      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20220705",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "64 YR",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Insufficient Information",
            "Insufficient Information"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20220630",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "14934303",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary report",
      "remedial_action": [
        ""
      ],
      "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": "",
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      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "295430301",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "DURING THE PROCEDURE, THE SCRUB TECH NOTICED THAT THE INSTRUMENT PULLED OUT FROM THE ABDOMEN WAS MISSING THE TIP COVER. SHE LOOKED AROUND AND MADE SURE IT WASN'T IN HER FIELD AND INFORMED THE SURGEON AND ASSISTANT SURGEON. THE TEAM IN THE ROOM LOOKED THRU AND AROUND THE STERILE FIELD, AND ALSO WENT THRU THE TRASH, BUT WERE UNABLE TO FIND THE MISSING TIP COVER. THE SURGEON AND ASSISTANT EXPLORED INSIDE THROUGH THE SCOPE BEFORE AND AFTER SPECIMEN WAS REMOVED. XRAY DID NOT REVEAL ANY FOREIGN BODY. FDA SAFETY REPORT ID# (B)(4)."
        }
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      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}