{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
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      "report_to_fda": "",
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      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2955842-2012-00404",
      "type_of_report": [
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        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20120828",
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      "manufacturer_contact_plocal": "",
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      "source_type": [
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "",
      "manufacturer_contact_area_code": "",
      "date_added": "20120829",
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      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1",
          "date_received": "20120828",
          "brand_name": "DA VINCI SURGICAL SYSTEM",
          "generic_name": "ENDOSCOPIC INSTRUMENT CONTROL SYSTEM",
          "manufacturer_d_name": "INTUITIVE SURGICAL,INC.",
          "manufacturer_d_address_1": "",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SUNNYVALE",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
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          "lot_number": "",
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          "device_age_text": "DA",
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            "medical_specialty_description": "Gastroenterology, Urology",
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            "device_class": "2"
          }
        }
      ],
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      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "FDA Requested",
      "manufacturer_contact_country": "",
      "date_changed": "20250808",
      "health_professional": "",
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          "patient_sequence_number": "1",
          "date_received": "20120828",
          "sequence_number_treatment": [
            "DA VINCI SURGICAL SYSTEM INSTRUMENTS & ACCESSORIE"
          ],
          "sequence_number_outcome": [
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          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
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          "patient_problems": [
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          ]
        }
      ],
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      "date_report": "20130114",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "2718569",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20120803",
      "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": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "3050383",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(4) 2012, INTUITIVE SURGICAL RECEIVED THE FOLLOWING COMMENTS VIA AN ANONYMOUS ONLINE SURVEY CONCERNING THE OUTCOME OF A SURGICAL PROCEDURE THAT WAS PERFORMED USING THE DA VINCI SURGICAL SYSTEM. THE INFORMATION RECEIVED IS AS FOLLOWS: SOME COMPLICATIONS AFTER SURGERY, RESULTED IN INTERNAL LEAKING AND RETURN TO HOSPITAL TO HAVE DRAIN AND CATHETER INSTALLED FOR FURTHER THREE WEEKS. ON THE POSITIVE SIDE I HAD VERY GOOD BLADDER CONTROL WITHIN HOURS OF CATHETER AND DRAIN REMOVAL."
        },
        {
          "mdr_text_key": "10215550",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "DUE TO THE LIMITED INFORMATION PROVIDED IN THE SURVEY, INTUITIVE SURGICAL IS UNABLE TO FOLLOW UP WITH THE REPORTER TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED CONCERNING THE REPORTED EVENT, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED TO THE FDA."
        },
        {
          "mdr_text_key": "20171919",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4)."
        }
      ],
      "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": "01/14/2013"
    }
  ]
}