{ "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": "2955842-2011-00061", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20110301", "manufacturer_address_2": "", "pma_pmn_number": "K081207", "date_of_event": "20101203", "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": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110301", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110301", "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": "", "device_evaluated_by_manufacturer": "N", "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": [ "Poor Quality Image", "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "LA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250805", "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": "20110301", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20101206", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2003418", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20101206", "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": "18959827", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE INITIAL REPORTER CONFIRMED THAT THE SYSTEM AND ASSOCIATED INSTRUMENTS/ACCESSORIES DID NOT MALFUNCTION DURING THE SURGICAL PROCEDURE AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT INJURY. THE INITIAL REPORTER ALSO INDICATED THAT THE PATIENT IS RECOVERING WELL AND NO POST SURGICAL COMPLICATIONS WERE REPORTED. BASED ON THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DA VINCI S SURGICAL SYSTEM WORKED AS INTENDED, NO DEVICE FAILURE OCCURRED, AND THE PATIENT INJURY WAS UNRELATED TO THE DA VINCI S SURGICAL SYSTEM." }, { "mdr_text_key": "19105187", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI S RECTOPEXY PROCEDURE THE SURGEON EXPERIENCED VISUALIZATION ISSUES DUE THE PATIENT'S EXTREMELY LARGE UTERUS. DUE TO THE POOR VISION, THE SURGEON INADVERTENTLY HIT A VESSEL OVER THE SACRAL PROMONTORY AND UNCONTROLLABLE BLEEDING OCCURRED. AS A RESULT, THE SURGEON CONVERTED TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO MAINTAIN THE BLEEDING AND COMPLETE THE PLANNED PROCEDURE. THE DELAY IN REPORTING IS A RESULT OF THE COMPLAINT HANDLING TEAM MISTAKENLY BELIEVING THAT THE COMPLAINT INFORMATION HAD ALREADY BEEN RECORDED IN THE COMPLAINT DATABASE." } ], "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": "" } ] }