{ "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": "2955842-2013-00240", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130122", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20121221", "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": "20130122", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "30638", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130122", "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- A60P7", "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": [ "Poor Quality Image" ], "reporter_state_code": "OH", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "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": "20130122", "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", "Tissue Damage" ] } ], "distributor_city": "", "date_report": "20121221", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2923387", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20121221", "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": "16056304", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, AN EMERGENCY CONVERSION TO OPEN SURGERY DUE TO LACK OF VISUALIZATION HAD OCCURRED. THE PATIENT EXPIRED DURING THE OPEN PROCEDURE. THERE WERE NO REPORTS OF ANY SYSTEM, INSTRUMENT(S) AND/OR ACCESSORY(IES) MALFUNCTION DURING THE COURSE OF THE PROCEDURE." }, { "mdr_text_key": "16430049", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "DURING A FOLLOW UP CALL ON (B)(4) 2012 WITH THE COMPANY REPRESENTATIVE WHO WAS PRESENT DURING THIS EVENT, IT WAS INDICATED THAT DURING THIS DA VINCI SI HYSTERECTOMY PROCEDURE THE SURGEON INADVERTENTLY DAMAGED A VESSEL WHILE TAKING DOWN ADHESIONS, CAUSING SIGNIFICANT BLEEDING INTO THE PATIENT'S ABDOMEN. REPORTEDLY, THE SURGEON WAS UNABLE TO CONTROL THE PATIENT'S BLEEDING AND THE PATIENT EXPIRED. IT IS UNKNOWN WHICH EXACT VESSEL WAS DAMAGED. ALLEGEDLY, THE SURGEON WAS AWARE THAT THE PATIENT HAD SIGNIFICANT ADHESIONS PRIOR TO STARTING THE PROCEDURE AND THE SURGEON WAS POSSIBLY GOING TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO MALFUNCTION OF THE DA VINCI SURGICAL SYSTEM, INSTRUMENTS AND/OR ACCESSORIES OCCURRED DURING THE SURGERY. DURING A SECONDARY FOLLOW-UP ON (B)(4) 2013 WITH THE NURSE, IT WAS STATED THAT THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT HAS ADVISED NOT TO PROVIDE ANY FURTHER INFORMATION, AS THIS EVENT WAS NOT RELATED TO ANY ISI DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS OBTAINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED." } ], "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": "" } ] }