{ "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": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "HOSPITAL", "report_to_fda": "", "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": "Injury", "report_number": "2955842-2011-00029", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20110121", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20101117", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110922", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110121", "brand_name": "DA VINCI S 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": "IS2000 A5.1P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Appropriate Device Problem Term/Code Not Available" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20110121", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "54 YR", "patient_sex": "", "patient_weight": "64", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Peritonitis", "Wound Infection" ] } ], "distributor_city": "", "date_report": "20130116", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "1966750", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20101224", "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": "8849968", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE SURGEON COMMENTED THAT THE SYSTEM FUNCTIONED PROPERLY AND NO ANOMALIES WERE NOTED DURING THE DA VINCI S SURGICAL PROCEDURE PERFORMED ON (B)(6) 2010. ALTHOUGH THE SYSTEM WAS USED IN THE AREA WHERE THE PERFORATION WAS DISCOVERED, THE SURGEON INDICATED THAT NO PERFORATIONS WERE OBSERVED DURING THE SURGICAL PROCEDURE. PER THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED AND NO SYSTEM MALFUNCTIONS OCCURRED." }, { "mdr_text_key": "10351722", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4)." }, { "mdr_text_key": "1726372", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT A SUCCESSFUL DA VINCI S PROSTATECTOMY PROCEDURE, HOWEVER, ON (B)(6) 2010, THE PATIENT BECAME FEBRILE AND BEGAN EXPERIENCING LOW ABDOMINAL TENDERNESS. ON (B)(6) 2010, THE PATIENT HAD A FEVER AND BLOOD IN HIS STOOL. ON (B)(6) 2010, A CT SCAN REVEALED THAT THE PATIENT HAD POSSIBLY DEVELOPED GENERALIZED PERITONITIS. A RE-OPERATION WAS PERFORMED AND A SIGMOID COLON PERFORATION WAS DISCOVERED. OPEN DRAINAGE WAS PERFORMED AND AN ARTIFICIAL ANUS WAS CREATED. BASED ON THE LAPAROTOMY FINDINGS, THE SYMPTOM SEEMED TO BE DELAYED FISTULATION. THE PATIENT RECOVERED AND WAS DISCHARGED ON (B)(6) 2010." } ], "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": "01/16/2013" } ] }