{ "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": "", "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": "2955842-2008-01205", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20080811", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20080717", "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": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20110912", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1", "date_received": "20080811", "brand_name": "DA VINCI S 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": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A5.1P4", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Yes", "date_returned_to_manufacturer": "20080722", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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", "No Flow" ], "reporter_state_code": "WI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250812", "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": "20080811", "sequence_number_treatment": [ "DA VINCI S SURGICAL SYSTEM INSTRUMENTS", " ACCESSORIES", " CARDICA FLEX A ANASTOMOSIS SYSTEM" ], "sequence_number_outcome": [ "Life Threatening", " R" ], "patient_age": "53 YR", "patient_sex": "", "patient_weight": "161", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Laceration(s)", "Ventilator Dependent" ] } ], "distributor_city": "", "date_report": "20080811", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "2240665", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20080717", "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": "2381615", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THIS REPORT IS BEING FILED BASED AN ISI INVESTIGATION CONCLUDING 08/08/2008. (B)(4) WAS RECEIVED ON 08/01/2008 FROM THE (B)(6). IT WAS REPORTED THAT DURING DA VINCI S BILATERAL INTERNAL MAMMARY ARTERIES REVASCULARIZATION PROCEDURE, THE CUSTOMER EXPERIENCED A SYSTEM ERROR CODE #23. WITH THE ASSISTANCE OF AN ISI (B)(4), THE SITE POWERED DOWN THE SYSTEM TO CLEAR THE FAULT. THE SITE CONTINUED WITH THE PROCEDURE, HOWEVER, THE SYSTEM ERROR REOCCURRED. THE SITE DISABLED THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) TO CONTINUE THE CASE. THE SITE THEN ELECTED TO MANUALLY MANIPULATE THE CAMERA AND ENDOSCOPE FOR APPROXIMATELY 5 TO 6 HOURS WHEN A LOSS OF CARBON DIOXIDE INSUFFLATION OCCURRED RESULTING IN THE HEART PUSHING UP INTO THE ENDOSCOPE TWO TIMES CAUSING LACERATIONS TO THE PATIENT'S RIGHT VENTRICLE. THE PROCEDURE WAS CONVERTED TO A THORACOTOMY TO PERFORMED A NON ROBOTIC REPAIR OF THE DAMAGED VENTRICLE WITH SEVERAL STITCHES AND TO COMPLETE THE PLANNED PROCEDURE. AFTER THE 14 HOUR PROCEDURE, THE PATIENT COULD NOT BE EXTUBATED NECESSITATING A TRACHEOSTOMY. AS OF (B)(6), THE PATIENT REMAINED UNDER CARE AT (B)(6)." }, { "mdr_text_key": "9288534", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE INVESTIGATION CONDUCTED BY (B)(4) CONCLUDED THAT THE SYSTEM ERROR CODE #23 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH A CONFIGURED EMBEDDED STERILIZER SETUP JOINT (CFG, ESSJ) AND REMOTE ARM CONTROLLER (RAC). THE EMBEDDED STERILIZER FOR SETUP-JOINT IS THE PRINTED CIRCUIT ASSEMBLY (PCA) INSIDE A SYSTEM ARM THAT MONITORS THE POTENTIOMETER FOR EACH OF FOUR JOINTS AND THEIR ASSOCIATED BACKUP POTENTIOMETERS. THE RAC CONSISTS OF FIVE PRINTED CIRCUIT ASSEMBLY BOARDS WHICH OPERATE TOGETHER TO PROVIDE CONTROL OF THE SYSTEM ARMS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CFG, ESSJ AND RAC. SYSTEM ERROR CODE #23 IS REPORTED BY SOFTWARE TO DENOTE THAT THE HARDWARE WHEEL \"WDOG\" HAS TRIPPED ON ONE OF THE DIGITAL COMMUNICATION LINKS IN THE SYSTEM. THIS MEANS THAT THE SYSTEM CANNOT RELIABLY COMMUNICATE OVER THE DIGITAL LINK AND THEREFORE CANNOT CONTINUE NORMAL OPERATION. COMMUNICATION FAULTS OCCASIONALLY OCCUR DUE TO TYPICALLY EITHER FAULTY ELECTRONICS OR POOR CONNECTIONS IN THE COMMUNICATION LINK. THE ERROR 23 FAULT INDICATED BY THE SYSTEM IN THIS CASE POINTED TO A COMMUNICATION ERROR INVOLVING THE ECM'S RAC AND ESSJ MODULES. THE SYSTEM WAS REPAIRED AS THE (B)(4) BOTH REMOVED THE ELECTRONICS THAT COULD HAVE EXPERIENCED AN INTERMITTENT FAILURE AND RE-SECURED ALL OF THE CONNECTIONS INVOLVED. FIELD EXPERIENCE HAS SHOWN THAT THESE MEASURES ARE EFFECTIVE IN RESOLVING THIS TYPE OF SYSTEM COMMUNICATION ISSUE. AS OF (B)(6) 2007, THE SITE HAS CONTINUED TO USE THE SYSTEM AND HAS NOT REPORTED RECURRENCES OF THIS ISSUE." } ], "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": "" } ] }