{ "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": "2955842-2017-00314", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20170519", "manufacturer_address_2": "", "pma_pmn_number": "K081137", "date_of_event": "20170424", "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": [ "HEALTH PROFESSIONAL" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20170519", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "358700", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170519", "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 A60P9B", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20170511", "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 Issue", "Device Displays Incorrect Message", "Device Issue", "Device Displays Incorrect Message" ], "reporter_state_code": "PA", "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": "20170519", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Injury" ] } ], "distributor_city": "", "date_report": "20170424", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6578152", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170424", "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": "75546680", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE RAC HAS BEEN RETURNED TO ISI FOR EVALUATION. HOWEVER, FAILURE ANALYSIS WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. THE RAC WAS INSTALLED ON AN IN-HOUSE SYSTEM AND TESTED. NO TROUBLE WAS FOUND WITH THE EVALUATION OF THE RAC. THE ROOT CAUSE OF THE PATIENT'S INTRA-OPERATIVE COMPLICATION IS UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. IN REGARDS TO NON-RECOVERABLE FAULTS, THE DA VINCI SI SURGICAL SYSTEM USER MANUAL STATES THE FOLLOWING: NON-RECOVERABLE FAULTS IF A FAULT IS NON-RECOVERABLE, THE SYSTEM MUST BE RESTARTED. THE FOLLOWING MESSAGE IS DISPLAYED: NON-RECOVERABLE FAULT: XXXX RESTART SYSTEM TO CONTINUE. RESTARTING THE SYSTEM DURING A PROCEDURE IF A NON-RECOVERABLE FAULT OCCURS DURING A PROCEDURE, YOU CAN RESTART THE SYSTEM WITHOUT HAVING TO REMOVE INSTRUMENTS AND ENDOSCOPE FROM THE PATIENT. FOLLOW THESE STEPS TO RESTART THE SYSTEM: POWER OFF THE SYSTEM: PRESS THE POWER BUTTON ON ANY SYSTEM COMPONENT. IT IS NOT NECESSARY TO REMOVE INSTRUMENTS OR ENDOSCOPE. THE SYSTEM TAKES SEVERAL SECONDS TO SHUT DOWN. WHEN COMPLETE, ALL SYSTEM POWER BUTTONS WILL BE LIT AMBER, INDICATING STANDBY MODE, AND READINESS FOR RESTART. RESTART THE SYSTEM: PRESS THE POWER BUTTON ON ANY SYSTEM COMPONENT. NOTE: DURING SYSTEM RESTART, VIDEO IS TEMPORARILY UNAVAILABLE AT THE SURGEON CONSOLE VIEWER AND TOUCHSCREEN MONITOR. NOTE: IF THE FAULT CANNOT BE CLEARED BY A SYSTEM RESTART, CALL INTUITIVE SURGICAL TECHNICAL SUPPORT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT ALLEGEDLY SUSTAINED AN UNSPECIFIED INJURY TO THE SIGMOID COLON. HOWEVER, AT THIS TIME, THE ROOT CAUSE AND SEVERITY OF THE BOWEL INJURY IS UNKNOWN. ALTHOUGH THE SURGICAL STAFF ENCOUNTERED A NON-RECOVERABLE SYSTEM FAULT, THE SYSTEM POWERED UP NORMALLY AFTER THE SYSTEM WAS POWERED CYCLED, AND THE SURGEON WAS ABLE TO PROCEED WITH THE SURGICAL PROCEDURE." }, { "mdr_text_key": "75546681", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SACROCOLPOPEXY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A NON-RECOVERABLE SYSTEM ERROR CODE 15. DURING THE REPORTED EVENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK) TO REMOVE THE PROGRASP FORCEPS INSTRUMENT. AFTER REMOVING ALL OF THE ROBOTIC INSTRUMENTS, THE SURGICAL STAFF POWER CYCLED THE DA VINCI SURGICAL SYSTEM. AFTER THE DA VINCI SURGICAL SYSTEM WAS REBOOTED, THE SYSTEM POWERED UP NORMALLY AND THE SURGEON WAS ABLE TO CONTINUE WITH THE SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT SUSTAINED UNSPECIFIED DAMAGE TO THE SIGMOID COLON DURING THE REPORTED EVENT. HOWEVER, THE ROOT CAUSE AND SEVERITY OF THE BOWEL INJURY ARE UNKNOWN. ON APRIL 25, 2017, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE REVIEWED THE SITE'S SYSTEM LOGS AND VERIFIED THAT A SYSTEM ERROR CODE 15 OCCURRED DURING THE SURGICAL PROCEDURE. HOWEVER, THE FSE WAS UNABLE TO REPRODUCE THE CUSTOMER REPORTED FAILURE MODE. THE FSE REPLACED REMOTE ARM CONTROLLER (RAC2) AS A PRECAUTION AND MOVED THE RAC2 TO THE RAC1 POSITION. THE FSE TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. THE RAC REFERS TO THE PRINTED CIRCUIT BOARD THAT RECEIVES SIGNALS FROM THE RAC CONTROL MODULE (RCM) WHICH PERFORMS ALL OF THE CONTROL, MONITORING, COMMUNICATIONS, AND UPPER-LEVEL SAFETY FUNCTIONS." } ], "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": "" } ] }