{ "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": "Death", "report_number": "2955842-2011-00082", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20110318", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "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 representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20110318", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20110318", "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 A6.0P5", "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": [ "Insufficient Device Problem Information" ], "reporter_state_code": "WA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "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": "20110318", "sequence_number_treatment": [ "DA VINCI SI INSTRUMENTS & ACCESSORIES, ESU" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Exsanguination", "Hemorrhage/Blood Loss/Bleeding" ] } ], "distributor_city": "", "date_report": "20110217", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2023904", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20110217", "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": "9163577", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(6) 2011, ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED BY DR. (B)(6), CONSOLE SURGEON WHO PERFORMED THE TORS PROCEDURE. DR. (B)(6) INDICATED THAT THE PATIENT UNDERWENT SURGERY FOR A BENIGN MASS AT THE BASE OF THE TONGUE, WHICH HAD BEEN CAUSING OBSTRUCTIVE SYMPTOMS FOR A YEAR AND THERE WAS NO OTHER WAY TO APPROACH THE LESION. DUE TO THE LOCATION OF THE MASS, DR. (B)(6) WAS CLOSE TO A BRANCH OF THE LINGUAL ARTERY. DR. (B)(6) CAUTERIZED THE ARTERY WITH BIPOLAR ENERGY AND PUT TISSEEL OVER IT. THE CASE WENT WELL, AND DR. (B)(6) DIDN'T HAVE TO GO TOO DEEP AND HAD GOOD VISUALIZATION. EIGHT DAYS POSTOP, THE PATIENT BEGAN TO BLEED. DR. (B)(6) MENTIONED THAT TYPICALLY A BLEED WITHIN 24-48 HOURS POSTOP IS CONSIDERED A TECHNICAL PROBLEM AND AFTER 48 HOURS, IT IS DUE TO A WOUND HEALING ISSUE WHICH EXPOSE THE VESSELS AND MAKE THEM MORE LIKELY TO BLEED. DR. (B)(6) INDICATED THAT THIS COMPLICATION IS A KNOWN RISK WITH A TRANSORAL APPROACH AND WAS NOT AT ALL RELATED TO ANY LIMITATIONS OF OR PROBLEMS WITH THE DA VINCI SI SURGICAL SYSTEM. BASED ON THE INFORMATION PROVIDED BY DR. (B)(6), IT WAS DETERMINED THAT THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM. IT WAS CONCLUDED THAT THE DA VINCI SI SURGICAL SYSTEM WORKED AS INTENDED AND DID NOT MALFUNCTION IN A WAY THAT WOULD HAVE LED OR CONTRIBUTED TO THE PATIENT'S DEATH." }, { "mdr_text_key": "1913539", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT EIGHT DAYS AFTER A DA VINCI SI TONGUE BASE RESECTION (TORS) PROCEDURE WAS SUCCESSFULLY PERFORMED, THE PATIENT EXPIRED DUE TO UNCONTROLLABLE POST OPERATIVE BLEEDING." } ], "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": "" } ] }