{
  "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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  "results": [
    {
      "manufacturer_contact_zip_ext": "",
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      "event_location": "I",
      "report_to_fda": "*",
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      "manufacturer_contact_address_1": "",
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      "report_number": "2955842-2017-00277",
      "type_of_report": [
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      "date_received": "20170505",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K081137",
      "date_of_event": "20170323",
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      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "OTHER",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20170505",
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      "device": [
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          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20170505",
          "brand_name": "DA VINCI SI 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": "IS3000 A60P9B",
          "catalog_number": "",
          "lot_number": "",
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          "device_evaluated_by_manufacturer": "",
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          "udi_di": "",
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          "openfda": {
            "device_name": "System, Surgical, Computer Controlled Instrument",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.1500",
            "device_class": "2"
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      "product_problems": [
        "Insufficient Device Problem Information",
        "Insufficient Device Problem Information"
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      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250824",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
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          "patient_sequence_number": "1",
          "date_received": "20170505",
          "sequence_number_treatment": [
            ""
          ],
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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            "Internal Organ Perforation",
            "Blood Loss",
            "Embolism",
            "Internal Organ Perforation",
            "Blood Loss"
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        }
      ],
      "distributor_city": "",
      "date_report": "20170411",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "6547806",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20170411",
      "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",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "74584454",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSES FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT. IT IS UNKNOWN IF THE GASTRIC PERFORATION OCCURRED DURING THE DIAGNOSTIC LAPAROSCOPY PROCEDURE OR THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.  ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2013. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. EACH REUSABLE (MULTI-USE) INSTRUMENT USED DURING THE DA VINCI SURGICAL PROCEDURE HAS BEEN USED IN SUBSEQUENT SURGICAL PROCEDURES WITHOUT ANY REPORTED ISSUES.  THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A GASTRIC PERFORATION, DEVELOPED AN UNSPECIFIED EMBOLISM, AND EXPERIENCED A GI BLEED. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE -POSTOPERATIVE COMPLICATIONS ARE UNKNOWN."
        },
        {
          "mdr_text_key": "74584455",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT AFTER UNDERGOING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT WAS FOUND TO HAVE SUSTAINED A GASTRIC PERFORATION ON POST-OPERATIVE DAY 1. PRIOR TO UNDERGOING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT HAD ALSO UNDERGONE A DIAGNOSTIC LAPAROSCOPY PROCEDURE WITH ADHESIOLYSIS. A SURGEON REPAIRED THE GASTRIC PERFORATION VIA OPEN SURGERY AND HAD TO REMOVE MESH. AFTER GOING HOME, THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED EMBOLISM AND GI BLEED. NO FURTHER CLINICAL INFORMATION WAS PROVIDED."
        }
      ],
      "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": ""
    }
  ]
}