{ "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": "I", "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": "Injury", "report_number": "2955842-2017-00005", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "", "date_received": "20170105", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20161213", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "HEALTH PROFESSIONAL", "OTHER" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170105", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "9400", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170105", "brand_name": "DA VINCI XI 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": "IS4000 A70P5D", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20161220", "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": [ "Energy Output To Patient Tissue Incorrect", "Energy Output To Patient Tissue Incorrect" ], "reporter_state_code": "CO", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "*", "mfr_report_type": "FDA Requested", "manufacturer_contact_country": "", "date_changed": "20250813", "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": "20170105", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bowel Burn", "Bowel Burn" ] } ], "distributor_city": "", "date_report": "20161213", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6226793", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20161213", "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": "63980277", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE IESU INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED TO ISI FOR EVALUATION. THE CUSTOMER REPORTED FAILURE MODE COULD NOT BE REPRODUCED OR CONFIRMED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. BOTH BIPOLAR PORTS AND MONOPOLAR PORTS RECOGNIZED AND STOPPED THE INSTRUMENTS. THE UNIT ENERGIZED AND CAUTERIZED WELL WITH NO TROUBLE FOUND. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2016. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE, THE PATIENT ALLEGEDLY EXPERIENCED A BURN ON THE SIGMOID COLON THAT REQUIRED SUTURES. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE BURN IS UNKNOWN." }, { "mdr_text_key": "63980278", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED TOTAL BENIGN HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE ENERGY WAS ALLEGEDLY CUTTING TOO MUCH TISSUE. THE INITIAL REPORTER CLAIMED THAT BIPOLAR AND MONOPOLAR ENERGY WAS NOT STOPPING AND WAS BURNING THROUGH TOO MUCH TISSUE. ON (B)(6) 2016, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE'S OR ASSISTANT DIRECTOR AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE OR ASSISTANT DIRECTOR STATED THAT THE ENERGY TRAVELED DURING THE PROCEDURE, WHICH RESULTED IN A THERMAL BURN ON A FALLOPIAN TUBE AND THE SIGMOID COLON ADJACENT TO IT. IT WAS CONFIRMED THAT THERE WAS NO ARCING SEEN BY THE SURGEON OR THE BEDSIDE ASSISTANTS; HOWEVER, WHEN THE FALLOPIAN TUBE WAS MOVED THE SURGEON SAW EVIDENCE OF A BURN ON IT AND ON THE SIGMOID COLON. AT THIS TIME THE SURGEON INSPECTED THE SIGMOID COLON AND FOUND IT HAD A LEAK, THE SURGEON APPLIED SUTURES TO STOP THE LEAK. PHOTOGRAPHIC IMAGES OF THE PATIENT'S INJURY WERE REVIEWED BY THE HOSPITAL STAFF AND IT WAS REPORTED THAT THERE WAS A LARGE DISTANCE BETWEEN THE INJURED TISSUE AND THE INSTRUMENTS USED. THE SITE REPORTED THAT THE INSTRUMENTS ARE ALWAYS EXAMINED PRIOR TO USE, AND THERE WERE NO COLLISIONS OF INSTRUMENTS DURING THE PROCEDURE. THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) SETTINGS WERE NORMAL. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED ROBOTICALLY AND THE PATIENT WAS REPORTED TO BE RECOVERING WELL. ON 12/14/2016, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED AN ONSITE EVALUATION OF THE DA VINCI SYSTEM AND THE INSTRUMENTS USED IN THE SURGICAL PROCEDURE. THE FSE WAS NOT ABLE TO REPLICATE OR CONFIRM THE CUSTOMER REPORTED ISSUE, HOWEVER THE FSE REPLACED THE IESU PER THE CUSTOMER'S REQUEST. AS OF THE DATE OF THIS REPORT, NO SIMILAR SUBSEQUENT EVENTS HAVE BEEN REPORTED BY THE HOSPITAL. THE INITIAL REPORTER STATED THAT THEY BELIEVED THERE WAS NO MALFUNCTION OF THE CAUTERY INSTRUMENTS." }, { "mdr_text_key": "77655318", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MARYLAND BIPOLAR FORCEPS INSTRUMENT AND THE PERMANENT CAUTERY SPATULA INSTRUMENT INVOLVED WITH THIS EVENT AND HAVE BEEN EVALUATED. FAILURE ANALYSIS WAS UNABLE TO REPLICATE OR CONFIRM THE REPORTED COMPLAINT ON EITHER OF THE RETURNED INSTRUMENT. THERE WAS NO THERMAL DAMAGE FOUND ON EITHER OF THE INSTRUMENTS. BOTH INSTRUMENTS PASSED THE ELECTRICAL CONTINUITY TEST WITH NO TROUBLE FOUND. BASED ON AN EVALUATION OF THE MARYLAND BIPOLAR FORCEPS AND PERMANENT CAUTERY SPATULA INSTRUMENTS, THERE IS NO INDICATION THAT A MALFUNCTION OF THE INSTRUMENTS USED DURING THIS PROCEDURE OCCURRED." } ], "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": "06/13/2017" } ] }