{ "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": "2955842-2013-00891", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20130318", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20130211", "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": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130319", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "111862", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130318", "brand_name": "DA VINCI SI 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 A60.P6", "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": [ "Device Operates Differently Than Expected" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250811", "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": "20130318", "sequence_number_treatment": [ "DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Death" ], "patient_age": "50 YR", "patient_sex": "", "patient_weight": "68", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Death", "Pain", "Septic Shock", "Injury" ] } ], "distributor_city": "", "date_report": "20130218", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3009969", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130218", "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": "20899475", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "ON (B)(4) 2013, THE ISI COMPANY REPRESENTATIVE WAS CONTACTED TO REQUEST ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT. IT WAS INDICATED THAT NO MALFUNCTIONS OCCURRED WITH THE DA VINCI SI SYSTEM, INSTRUMENTS OR ACCESSORIES; NO COMPLICATIONS WERE NOTED DURING THE SURGERY. IT WAS REPORTED THAT THE INITIAL SURGERY WAS UNEVENTFUL AND THERE WERE NO ADHESIONS. THE MANUFACTURER OF THE TROCAR IS UNKNOWN AT THE TIME OF THIS REPORT. THE PATIENT'S PRIOR MEDIAL HISTORY IS NOT KNOWN. A REVIEW OF SYSTEM LOGS FOR THE SYSTEM ALLEGEDLY USED IN THE PROCEDURE DID NOT PRODUCE ANY DATA FOR THE GIVEN SYSTEM AT THE TIME PERIOD INDICATED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST ENGINEERING EVALUATION), OR IF ADDITIONAL INFORMATION IS RECEIVED." }, { "mdr_text_key": "20634164", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS ALLEGED THAT THE PATIENT HAD A MULTI-PORT CHOLECYSTECTOMY ON (B)(6) 2013 THAT RESULTED IN AN INJURY TO THE BOWEL FROM THE TROCAR DURING INSERTION AT THE BEGINNING OF THE CASE. THE PATIENT COMPLAINED ABOUT PAIN TWO DAYS AFTER THE SURGERY AND RETURNED TO THE HOSPITAL. THE PATIENT WAS READMITTED, ALLEGEDLY SEPTIC AND AN EMERGENCY SURGERY WAS PERFORMED TO REPAIR THE BOWEL. THE PATIENT EXPIRED ON (B)(6) 2013." } ], "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": "" } ] }