{ "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": "2955842-2017-00724", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20171101", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20171003", "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": [ "FOREIGN", "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "NL", "manufacturer_contact_area_code": "", "date_added": "20171101", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "773234", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20171101", "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", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20171016", "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 Displays Incorrect Message", "Device Operates Differently Than Expected", "Device Displays Incorrect Message", "Device Operates Differently Than Expected" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250814", "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": "20171101", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Nerve Damage", "Nerve Damage" ] } ], "distributor_city": "", "date_report": "20171017", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6994413", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20171017", "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": "90805454", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE ICB UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE UNIT WAS INSTALLED INTO A TEST SYSTEM WITH AN IN-HOUSE VESSEL SEALER INSTRUMENT AND THE INSTRUMENT PASSED 10 TIMES WITH BIPOLAR AND MONOPOLAR INSTRUMENTS. THE POWER SUPPLY WILL BE REPLACED AS PRECAUTION. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. THE ROBOTIC PORTION OF THE SURGICAL PROCEDURE LASTED APPROXIMATELY 23 MINUTES. DURING THIS TIME, A SYSTEM ERROR CODE 32053 OCCURRED THREE TIMES. A SYSTEM ERROR CODE 32053 IS GENERATED WHEN THE SYSTEM CANNOT COMMUNICATE WITH ONE OF THE ICB NODES. THIS FAULT INDICATES THAT THE SYSTEM DID NOT RECEIVE EVEN A SINGLE HEARTBEAT RESPONSE AT SYSTEM STARTUP. VESSEL SEALING INSTRUMENTS MAY NOT BE SUPPORTED. THIS COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. FURTHERMORE, DUE TO THE REPORTED ISSUE, THE SURGEON CONVERTED THE DA VINCI-ASSISTED PROCEDURE TO LAPAROSCOPIC. HOWEVER, THE SURGEON WAS UNABLE TO SEE AND SUBSEQUENTLY CONVERTED THE LAPAROSCOPIC PROCEDURE TO OPEN SURGERY. DURING CONVERSION TO OPEN SURGERY, NERVE DAMAGE WAS IDENTIFIED. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT." }, { "mdr_text_key": "90805455", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED LOWER ANTERIOR RESECTION PROCEDURE, THE CUSTOMER EXPERIENCED A REPEATED 32053 ERROR. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE ERROR AT SYSTEM START-UP. THE TSE ADVISED THE CUSTOMER TO CHECK IF THE POWER CORD WAS PROPERLY SEATED AND IT WAS. IT WAS ALSO CONFIRMED THAT THE POWER CORD WAS PROPERLY CONNECTED TO THE POWER STRIP AND THAT THE POWER SWITCH WAS ON. THE CUSTOMER POWER CYCLED THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. THE INSTRUMENT CONTROL BOX (ICB) WOULD NOT POWER ON AND THE POWER LED WAS NOTED TO BE OFF. THE TSE ADVISED THE CUSTOMER TO HAVE THEIR BIOMED CHECK THE FUSES AND VOLTAGE PRESSURE AT THE POWER CORD. IT WAS REPORTED THAT THE CUSTOMER WOULD PROCEED WITH THE CASE WITHOUT USE OF THE VESSEL SEALER INSTRUMENT. ISI MADE MULTIPLE FOLLOW UP ATTEMPTS AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT WAS ADMINISTERED AN HOUR AND A HALF OF ADDITIONAL ANESTHESIA DUE TO THE TROUBLESHOOTING PERFORMED. THE SURGEON THEN DECIDED TO CONVERT THE PROCEDURE TO A TRADITIONAL LAPAROSCOPIC PROCEDURE DUE TO THE REPORTED ISSUE. HOWEVER, THE SURGEON WAS UNABLE TO SEE WITH THE LAPAROSCOPIC CAMERA AND WAS DIFFICULT TO PERFORM LAPAROSCOPICALLY AND DECIDED TO CONVERT THE LAPAROSCOPIC PROCEDURE TO AN OPEN SURGERICAL PROCEDURE. DUE TO THE CONVERSION, SOME OF THE PATIENT'S PELVIC NERVES WERE DAMAGED. THE SURGEON INFORMED THE PATIENT ABOUT THE DAMAGE." } ], "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": "" } ] }