{ "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": "2955842-2012-00202", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20120509", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20120409", "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": "20120510", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20120509", "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 A6.0P6", "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": [ "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250827", "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": "20120509", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "81 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Hemorrhage/Blood Loss/Bleeding", "Injury" ] } ], "distributor_city": "", "date_report": "20120409", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2567858", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20120409", "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": "2811614", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI SI PROCEDURE WHEN THE ASSISTANT AT THE PATIENT SIDE CART (PSC) PERFORMED A TOOL CHANGE TO SWITCH THE INSTRUMENTS IN THE PATIENT SIDE MANIPULATOR (PSM) ARMS, THE PATIENT'S AORTA WAS PUNCTURED. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION RIGHT AFTER THE OPEN SURGICAL PROCEDURE, HOWEVER, THE PATIENT EXPIRED THE FOLLOWING DAY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING." }, { "mdr_text_key": "9866445", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE ISI CLINICAL SALES REPRESENTATIVE FOLLOWED UP WITH THE ASSISTANT RN AND THE RN INDICATED THAT THE PATIENT SIDE ASSISTANT HAD NOT RECEIVED TRAINING BY THE SITE ON HOW TO PERFORM A GUIDED TOOL CHANGE. BASED ON THE INFORMATION PROVIDED, THE PUNCTURING OF THE PATIENT AORTA IS THE RESULT OF AN INCORRECT INSTRUMENT CHANGE. THE SURGEON HAD REQUESTED THAT INSTRUMENTS LOCATED ON THE PATIENT SIDE MANIPULATORS (PSM) ARMS BE SWAPPED, SUCH THAT THE INSTRUMENT ON PSM ARM 1 WOULD BE SWITCHED WITH THE INSTRUMENT LOCATED ON PSM ARM 2. IT IS NOT CLEAR WHETHER THE ASSISTANT NURSE USED A GUIDED TOOL CHANGE TO SAFELY CHANGE INSTRUMENTS OR WHETHER THE NURSE USED THE ARM CLUTCH TO INSERT THE INSTRUMENT MANUALLY. IT IS UNCLEAR WHETHER ANY MALFUNCTION OF THE SYSTEM OCCURRED AND THE EXACT MECHANISM WHICH RESULTED IN PUNCTURING OF THE AORTA. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION AND ONCE THIS INFORMATION HAS BEEN RECEIVED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE DA VINCI SI INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: WARNING: THE INSTRUMENT MAY NOT BE IMMEDIATELY VISIBLE WHEN BEING MOVED FROM THE CANNULA INTO THE PATIENT. USE APPROPRIATE CAUTION WHEN MANUALLY INSERTING INSTRUMENTS INTO THE PATIENT." } ], "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": "" } ] }