{ "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": "2955842-2015-01151", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20150828", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20150722", "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": "20150828", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "571901", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150828", "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 A6.0P9", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250808", "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": "20150828", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20150730", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "5039247", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150730", "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": "28840202", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON 10/07/2015, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON: THE PATIENT WAS A (B)(6) MALE WHO PASSED AWAY ON (B)(6) 2015. THE PATIENT WAS A HEAVY SMOKER AND DRINKER. HE HAD A DRUG HISTORY CONSISTING OF PROPANOLOL. PRIOR TO UNDERGOING THE DA VINCI SURGICAL PROCEDURE, THE PATIENT PRESENTED WITH A 3 MONTH HISTORY OF A SORE THROAT AND RIGHT OTALGIA. AN ORAL CAVITY EXAMINATION REVEALED A RIGHT TONSIL AND TONGUE BASE LESION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI-ASSISTED TORS AND NECK DISSECTION PROCEDURE. THE PATIENT EXPERIENCED A POST-OPERATIVE COMPLICATION OF A NECK HAEMATOMA WHICH WAS TREATED WITH NECK EXPLORATION AND ARREST OF HAEMORRHAGE. THE SURGEON INDICATED THAT THERE WAS NO ISSUE WITH ROBOTIC RESECTION WHICH LASTED ABOUT 20 MINUTES. THE SURGEON ALSO INDICATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS SECONDARY HAEMORRHAGE. THE SURGEON STATED THAT THE CAUSE OF DEATH WAS NOT DUE TO ROBOTIC RESECTION. ACCORDING TO THE SURGEON, THE HISTOLOGY SHOWED SQUAMOUS CELL CARCINOMA T1N0M0. BASED ON THE ADDITIONAL INFORMATION PROVIDED, THIS COMPLAINT IS NO LONGER DEEMED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE SURGEON INDICATED THE PATIENT'S DEATH WAS NOT CAUSED BY ANY ISSUES WITH THE DA VINCI SURGICAL SYSTEM OR THE ROBOTIC RESECTION. ALSO, THE SURGEON INDICATED THAT THERE WERE NO ISSUES WITH THE ROBOTIC RESECTION AND THAT NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, THE INITIAL MDR SUBMITTED FOR THIS COMPLAINT IS BEING RETRACTED." }, { "mdr_text_key": "24441510", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEMISE. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE DA VINCI SURGICAL PROCEDURE. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI TORS PROCEDURE, THE PATIENT PASSED AWAY ON POST-OPERATIVE DAY 6. HOWEVER, AT THIS TIME, THE CAUSE OF THE PATIENT'S DEMISE IS UNKNOWN." }, { "mdr_text_key": "24441511", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI TORS PROCEDURE, THE PATIENT PASSED A FEW DAYS LATER. ON (B)(6) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE CSR WAS NOT PRESENT DURING THE SURGICAL PROCEDURE WHICH WAS NOT RECORDED ON VIDEO. ACCORDING TO THE CSR, NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF ANY INTRA-OPERATIVE COMPLICATIONS DURING THE DA VINCI SURGERY. THE CSR INDICATED THAT THE PATIENT PASSED AWAY ON (B)(6) 2015 AND AN AUTOPSY WAS TO BE PERFORMED." } ], "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": "10/15/2015" } ] }