{ "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": "2955842-2017-00113", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20170217", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20170118", "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": "FR", "manufacturer_contact_area_code": "", "date_added": "20170217", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "121353", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20170217", "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": "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": [ "Insufficient Device Problem Information", "Insufficient Device Problem Information" ], "reporter_state_code": "", "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": "20170217", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Injury", "Blood Loss", "Injury", "Blood Loss" ] } ], "distributor_city": "", "date_report": "20170127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "6339344", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20170127", "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": "67699936", "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 INTRA-OPERATIVE COMPLICATION(S) EXPERIENCED BY THE PATIENT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI HAS REVIEWED THE SITE'S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2017. APPROXIMATELY ONE HOUR AFTER THE SURGICAL PROCEDURE BEGAN, THE SYSTEM LOGS REVEAL THAT THE SURGICAL STAFF ENCOUNTERED ERROR CODES 22027 AND 26008. A SYSTEM ERROR CODE 22027 IS GENERATED WHEN THE SYSTEM HAS DETECTED THE USE OF THE MANUAL GRIP RELEASE WRENCH OR IRK WHILE THE INSTRUMENT JOINTS ARE IN A LOCKED STATE. A SYSTEM ERROR CODE 26008 IS GENERATED WHEN THE SYSTEM HAS DETECTED THAT THE USER IS POSSIBLY ATTEMPTING TO USE THE IRK WITHOUT HITTING THE EMERGENCY STOP (E-STOP) BUTTON. THE DA VINCI XI SYSTEM USER MANUAL STATES, WARNING: DO NOT PERFORM GRIP RELEASE ON A NON-FAULTED SYSTEM WITHOUT FIRST PRESSING THE EMERGENCY STOP BUTTON. FAILURE TO OBSERVE THIS WARNING MAY RESULT IN UNINTENDED INSTRUMENT MOTION OR DAMAGE TO THE GRIP RELEASE MECHANISM. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT SUSTAINED AN UNSPECIFIED INJURY AND EXPERIENCED BLEEDING THAT WAS CONTROLLED AFTER THE SURGEON USED A CADIERE FORCEPS INSTRUMENT TO CLAMP DOWN ON THE AFFECTED VESSEL. IN ADDITION, DUE TO THE UNSPECIFIED INJURY, THE SURGEON CONVERTED THE SURGICAL PROCEDURE TO OPEN SURGERY. AT THIS TIME THE ROOT CAUSE, SEVERITY, AND TYPE OF INJURY SUSTAINED BY THE PATIENT IS UNKNOWN." }, { "mdr_text_key": "67699937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS INITIALLY REPORTED THAT DURING A DA VINCI-ASSISTED BILIARY PANCREATIC DIVERSION PROCEDURE, THE PATIENT HAD AN ARTERIO-VENOUS LESION, A CADIERE FORCEPS INSTRUMENT WAS USED AS A CLAMP, AND THE SURGICAL PROCEDURE WAS CONVERTED TO OPEN SURGERY. IN ORDER TO REMOVE THE CADIERE FORCEPS INSTRUMENT, THE SURGICAL STAFF USED AN INSTRUMENT RELEASE KIT (IRK). ON (B)(6) 2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE SURGEON INDICATED THAT THE PATIENT SUSTAINED AN UNSPECIFIED INJURY AND HE USED THE CADIERE FORCEPS INSTRUMENT TO CONTROL BLEEDING FROM THE CAVERNOMA PORTAL VEIN. THE SURGEON DID NOT PROVIDE DETAILS REGARDING THE INJURY SUSTAINED BY THE PATIENT OR THE CAUSE OF THE BLEEDING FROM THE BLOOD VESSEL. DUE TO THE UNSPECIFIED INJURY, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI-ASSISTED SURGICAL PROCEDURE TO OPEN SURGERY. DURING THE CONVERSION TO OPEN SURGERY, THE SURGICAL STAFF WAS ABLE TO UNDOCK THREE OF FOUR ROBOTIC ARMS THAT WERE INSTALLED ON THE PATIENT SIDE CART (PSC). HOWEVER, THE SURGICAL STAFF HAD DIFFICULTY OPENING THE JAWS OF A CADIERE FORCEPS INSTRUMENT THAT WAS INSTALLED ON THE FOURTH ROBOTIC ARM. THE SURGICAL STAFF ENDED UP USING AN INSTRUMENT RELEASE KIT (IRK) TOOL TO REMOVE THE INSTRUMENT. THE SURGEON EXPLAINED THAT THE ISSUE WITH THE CADIERE FORCEPS INSTRUMENT WAS NOT THE CAUSE OF THE UNSPECIFIED INJURY SUSTAINED BY THE PATIENT. AS A RESULT OF THE REPORTED EVENT, THE SURGEON INDICATED THAT THE PATIENT RECEIVED AN ADDITIONAL THREE HOURS OF ANESTHESIA. NO POST-OPERATIVE COMPLICATIONS HAVE BEEN REPORTED AS OF THE DATE OF THIS REPORT." } ], "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": "" } ] }