{ "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": "Injury", "report_number": "2955842-2015-00986", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20150710", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20150601", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20150713", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "449836", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20150710", "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 A7.0P3B", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20150612", "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 Inoperable", "Device Displays Incorrect Message" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250804", "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": "20150710", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "89 YR", "patient_sex": "", "patient_weight": "73", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20150610", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "4906365", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20150610", "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": "6836566", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT DURING A DA VINCI CYSTECTOMY WITH AN ILIO CONDUIT AND LYMPH NODE DISSECTION PROCEDURE, THE SURGICAL STAFF ENCOUNTERED A SYSTEM ERROR CODE 252. A SYSTEM ERROR CODE 252 IS A NON-RECOVERABLE FAULT. PRIOR TO CONTACTING A TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE, THE SURGICAL STAFF RE-STARTED THE DA VINCI SURGICAL SYSTEM. HOWEVER, THE SYSTEM ERROR CODE 252 REAPPEARED. AFTER RESEATING THE BLUE AND ORANGE FIBER CABLES ON THE DA VINCI SURGICAL SYSTEM AND UNPLUGGING THE SCOPE FROM THE VIDEO PROCESSOR (VP), THE SYSTEM POWERED ON WITH NO ISSUES. THE SURGICAL STAFF WAS THEN ABLE TO RE-DOCK THE ROBOT. AN UNSPECIFIED TIME LATER, THE SURGICAL STAFF CONTACTED THE TSE AGAIN AFTER THE SYSTEM ERROR CODE 252 REAPPEARED. AT THAT TIME, THE SURGEON HAD ALREADY MADE THE DECISION TO CONVERT THE DA VINCI CYSTECTOMY PROCEDURE TO OPEN SURGERY. THE TSE ADVISED THE SURGICAL STAFF TO GET A NEW SCOPE AS A PRECAUTION. ON (B)(4) 2015, AN ISI TECHNICAL FIELD SPECIALIST (TFS) PERFORMED A FIELD EVALUATION AT THE SITE. THE TFS RESOLVED THE REPORTED SYSTEM ERROR CODE ISSUE BY REPLACING THE CORE AND VP. THE TFS THEN TESTED THE DA VINCI SURGICAL SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ON (B)(4) 2015, INTUITIVE SURGICAL, INC. (ISI) CONTACTED A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE DA VINCI SURGICAL PROCEDURE HAD BEEN IN PROGRESS FOR ABOUT 45 MINUTES WHEN THE REPORTED EVENT OCCURRED. THE NURSE INDICATED THAT THE SURGICAL STAFF FIRST ENCOUNTERED AN UNSPECIFIED ERROR CODE INVOLVING A NON-ISI ELECTROSURGICAL UNIT (ESU) AND THE USE OF AN UNSPECIFIED BIPOLAR INSTRUMENT. THE NURSE THEN INDICATED THAT THE ROBOT SHUT DOWN WITH THE UNRECOVERABLE FAULT CODE. THE NURSE STATED THAT THERE WAS NO HARM TO THE PATIENT OTHER THAN HAVING THE DA VINCI SURGICAL PROCEDURE CONVERTED TO OPEN SURGERY. ON (B)(4) 2015, ISI CONTACTED THE SURGEON AND OBTAINED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE SURGEON INDICATED THAT POST-OPERATIVELY, THE PATIENT EXPERIENCED ATRIAL FIBRILLATION, WENT TO THE ICU, AND HAD A PROLONGED POST-OP COURSE." }, { "mdr_text_key": "14203884", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE POST-OPERATIVE COMPLICATION EXPERIENCED BY THE PATIENT. A FOLLOW-UP MDR WILL BE SUBMITTED POST-FAILURE ANALYSIS EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. 12 - THE CORE WAS RETURNED TO ISI AND EVALUATED DUE TO A SYSTEM ERROR CODE 252 WHICH MEANS THAT ONE OF THE MASTER SUPERVISORY CONTROLLER'S (MSC) INTERFACES TIMED OUT. THE CORE WAS INSTALLED ON AN IN-HOUSE TEST SYSTEM AND AFTER CONFIGURING IT TO THE SYSTEM IT CAME UP WITH NO ERRORS, THE 252 ERROR WAS NOT REPLICATED. THE VIDEO APPEARED GOOD ON BOTH EYES AND ON BOTH THE HIGH RESOLUTION STEREO VIEWER (HRSV) AND THE VISION SIDE CART (VSC) MONITOR. THIS PROBLEM CAN BE CAUSED BY AN ISI CORE CONTROLLER (ICC) BOARD WITH A TS101 CHIP (U106) WITH A DATE CODE OF 1313 OR 1314. THE ICC IN THIS CORE WAS CONFIRMED TO HAVE A 1313 DATE CODE. THE VP WAS ALSO RETURNED TO ISI AND EVALUATED. THIS VP WAS INSTALLED ON AN IN-HOUSE TEST SYSTEM AND CAME UP WITH NO ERRORS. THE VP WAS TESTED AND NO TROUBLE WAS FOUND. A REVIEW OF THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2015 REVEALED THAT MULTIPLE SYSTEM ERROR CODE 252 OCCURRED DURING THE SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT WAS TRANSFERRED TO THE ICU AND DEVELOPED ATRIAL FIBRILLATION AFTER UNDERGOING THE PLANNED DA VINCI SURGICAL PROCEDURE THAT WAS CONVERTED TO OPEN SURGERY. HOWEVER, THE CAUSE OF POST-OPERATIVE COMPLICATION IS UNKNOWN." } ], "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": "" } ] }