{ "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": "2955842-2019-10250", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20190404", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20190312", "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": "20190404", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "278819", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20190404", "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": "IS3002-01", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "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": "04/02/2019", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20190404", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES", " DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Blood Loss", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20190312", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "8483681", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20190312", "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": "140933887", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE CURRENT INFORMATION PROVIDED, INTUITIVE SURGICAL, INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. THE BLOOD LOSS VOLUME AND MEDICAL INTERVENTION ADMINISTERED DUE TO THE HEMORRHAGING ARE UNKNOWN. IN ADDITION, THE DATE THE DA VINCI-ASSISTED SURGICAL PROCEDURE WAS PERFORMED IS UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED HEMORRHAGING AND THE CASE WAS CONVERTED TO OPEN SURGERY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS IS UNKNOWN." }, { "mdr_text_key": "140933888", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGICAL STAFF ENCOUNTERED BLEEDING. THE SURGICAL STAFF ATTEMPTED UNSUCCESSFULLY TO CONTROL THE BLEEDING USING A \"TACHOSIL TISSUE SEALING SHEET.\" ANOTHER PHYSICIAN WAS CALLED IN TO ASSESS THE EVENT. THE PATIENT¿S BLOOD PRESSURE HAD REPORTEDLY ¿DROPPED TO LESS THAN 60¿ DURING THE EVENT. THE CAUSE OF THE BLEEDING IS UNKNOWN AND IT IS UNCLEAR WHAT ADDITIONAL MEDICAL INTERVENTION, IF ANY, WAS ADMINISTERED DUE TO THE INTRA-OPERATIVE COMPLICATION. ON (B)(6) 2019, A PHYSICIAN FROM THE SITE PROVIDED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT EXPERIENCED HEMORRHAGING FROM THE PULMONARY VEINS AND THE CASE WAS CONVERTED TO A THORACOTOMY." }, { "mdr_text_key": "310557803", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 04/02/2019, INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON PERFORMED A DA VINCI-ASSISTED ESOPHAGECTOMY PROCEDURE ON (B)(6) 2019. IT IS UNKNOWN IF THE SURGICAL PROCEDURE WAS RECORDED ON VIDEO. THERE WERE NO REPORTS OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY DURING THE SURGICAL PROCEDURE. INTRA-OPERATIVELY, HEMORRHAGING FROM THE PULMONARY VEIN WAS IDENTIFIED BUT IT IS UNKNOWN WHAT SURGICAL TASK THE SURGEON WAS PERFORMING AT THE TIME. THE SURGICAL PROCEDURE WAS CONVERTED TO A THORACOTOMY AFTER THE PATIENT¿S CONDITION WORSENED AND HIS/HER BLOOD PRESSURE DECREASED TO BELOW 60MMHG. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED HEMORRHAGING AND THE CASE WAS CONVERTED TO OPEN SURGERY. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE INTRA-OPERATIVE COMPLICATIONS IS STILL UNKNOWN." }, { "mdr_text_key": "310557805", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "FOLLOW-UP INFORMATION." } ], "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": "04/11/2019" } ] }