{ "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": "I", "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": "2955842-2019-10468", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20190621", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20190610", "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": [ "COMPANY REPRESENTATIVE", "FOREIG" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20190621", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "516334", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190621", "brand_name": "DA VINCI", "generic_name": "DA VINCI SI SURGICAL SYSTEM", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "950 KIFER RD.", "manufacturer_d_address_2": "", "manufacturer_d_city": "SUNNYVALE", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94086", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94086", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS3001-01", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "", "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20190621", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Damage", "Blood Loss", "Tissue Damage", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20190610", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8722542", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190610", "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": "148804472", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED LAR PROCEDURE, A VESSEL WAS DAMAGED, BLEEDING OCCURRED, AND THE CASE WAS CONVERTED TO OPEN SURGERY. THE PATIENT REPORTEDLY RECEIVED A BLOOD TRANSFUSION AND THE VESSEL WAS REPAIRED. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE VESSEL INJURY IS UNKNOWN. THERE WAS NO REPORT OF A MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE." }, { "mdr_text_key": "148804473", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE EXTERNAL ILIAC ARTERY WAS DAMAGED AND BLEEDING OCCURRED. THE CASE WAS CONVERTED TO OPEN SURGERY. THE SURGEON DID NOT KNOW WHEN THE VESSEL WAS DAMAGED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. ON 06/18/2019, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. HOWEVER, THE VIDEO IS NOT AVAILABLE FOR ISI TO REVIEW. NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY WAS REPORTED. THE EXTERNAL ILIAC ARTERY APPEARED TO HAVE BEEN ¿PRICKED.¿ HOWEVER, IT IS UNKNOWN WHEN THE VESSEL INJURY ACTUALLY OCCURRED DURING THE SURGICAL PROCEDURE. THE ESTIMATED BLOOD LOSS FROM THE VESSEL INJURY IS ALSO UNKNOWN. THE SURGEON ELECTED TO CONVERT THE SURGICAL PROCEDURE TO OPEN SURGERY DUE TO THE VESSEL INJURY, BLEEDING, AND SINCE THE PATIENT HAD A ¿WEAK HEART,¿ WAS HYPERTENSIVE, AND OBESE. THE PATIENT REPORTEDLY RECEIVED A BLOOD TRANSFUSION. THE PLANNED LOW ANTERIOR RESECTION PROCEDURE WAS COMPLETED VIA OPEN SURGERY. AS A RESULT OF THE INCIDENT, THE PATIENT¿S HOSPITALIZATION WAS EXTENDED BUT NO POST-OPERATIVE COMPLICATIONS WERE REPORTED." } ], "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": "" } ] }