{ "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": "2955842-2013-04376", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20131011", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130904", "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": "20131015", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "522430", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20131011", "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 A6.0P8", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "MA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20131011", "sequence_number_treatment": [ "DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death" ] } ], "distributor_city": "", "date_report": "20130911", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3407041", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130911", "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": "3772500", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI SI SUPRAGLOTTIC RESECTION PROCEDURE PERFORMED ON (B)(6) 2013, A PATIENT SUBSEQUENTLY EXPIRED 2 DAYS LATER ON (B)(6) 2013. ACCORDING TO THE INITIAL REPORTER OF THIS COMPLAINT, THERE WERE NO COMPLICATIONS DURING THE DA VINCI SI SURGICAL PROCEDURE AND THE PATIENT HAD BEEN TAKEN TO THE ICU FOR RECOVERY." }, { "mdr_text_key": "11138850", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, INTUITIVE SURGICAL INC. (ISI) HAS NOT DETERMINED THE ROOT CAUSE FOR THE PATIENT'S DEMISE. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. ON (B)(4) 2013, ISI CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR)ASSIGNED TO THE SITE AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR, THERE WERE NO COMPLICATIONS DURING THE DA VINCI SI SURGICAL PROCEDURE. HE ALSO STATED THAT THERE WERE NO REPORTED MALFUNCTIONS OF THE DA VINCI SI SURGICAL SYSTEM DURING THE SURGICAL PROCEDURE. A DAY OR TWO AFTER THE SURGICAL PROCEDURE WAS COMPLETED, THE CSR INDICATED THAT THE PATIENT BEGAN TO COUGH FOR AN UNKNOWN REASON. THE CSR STATED THAT BY THE TIME THE SITE WAS ABLE TO ESTABLISH AN AIRWAY, THE PATIENT HAD EXPIRED. THE CSR DID NOT KNOW THE CAUSE OF PATIENT'S DEMISE. ON (B)(4) 2013, ISI ALSO CONTACTED THE SURGEON WHO PERFORMED THE DA VINCI SI SUPRAGLOTTIC RESECTION PROCEDURE. THE SURGEON INDICATED THAT THE PATIENT'S PREOPERATIVE DIAGNOSIS WAS SUPRAGLOTTIC CANCER OF THE LARYNX. ACCORDING TO THE SURGEON, THE DA VINCI SURGICAL PROCEDURE WENT SMOOTH AND WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS. ON POST-OP DAY 1, THE PATIENT WAS FOUND TO HAVE A PNEUMOTHORAX THAT HE ATTRIBUTED TO THE PATIENT'S HISTORY OF EMPHYSEMA. THE SURGEON DENIED THAT THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PNEUMOTHORAX. THE SURGEON STATED THAT THE CAUSE OF THE PATIENT'S DEATH WAS DUE TO A HEMORRHAGE AT THE SURGICAL SITE IN RELATION TO WOUND HEALING. THE SURGEON STATED THAT THE DA VINCI SI SURGICAL SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEMISE. ISI HAS ATTEMPTED TO CONTACT THE RISK MANAGEMENT DEPARTMENT AT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE RISK MANAGEMENT DEPARTMENT AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6), 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE PLANNED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT EXPIRED 2 DAYS AFTER COMPLETION OF A DA VINCI SI SURGICAL PROCEDURE. HOWEVER, THERE IS NO ALLEGATION THAT THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH." } ], "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": "" } ] }