{ "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": "2955842-2013-00829", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20130314", "manufacturer_address_2": "", "pma_pmn_number": "K063220", "date_of_event": "20130118", "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", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "", "date_added": "20130315", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "106910", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20130314", "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": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "IS2000 A51P8", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20130125", "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" ], "reporter_state_code": "OH", "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": "20130314", "sequence_number_treatment": [ "DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Code Available" ] } ], "distributor_city": "", "date_report": "20130212", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "3005314", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20130212", "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": "3377836", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI S PROSTATECTOMY PROCEDURE, DURING STARTUP OF THE DA VINCI S SYSTEM, THE CUSTOMER EXPERIENCED A PROBLEM WITH ERROR CODE 45341. THE SITE CONTACTED ISI FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOG BY THE TSE FOUND THAT THE SYSTEM ERROR CODE 45341 WAS RELATED TO THE VIDEO PROCESS ASSEMBLY ON THE DA VINCI S ROBOT SYSTEM. THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED SURGICAL PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM OR INJURY WAS INITIALLY REPORTED." }, { "mdr_text_key": "10543047", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE FIELD SERVICE ENGINEER VISITED THE SITE TO INSPECT THE DA VINCI ROBOT SYSTEM. HE REPLACED THE BLUE VISION CABLE, AND THE CAMERA HEAD. THE CAMERA HEAD PRODUCES THREE DIMENSIONAL IMAGES TO THE DA VINCI STANDARD VISION SYSTEM THROUGH RIGHT AND LEFT OPTICAL PATHS. THE IMAGES ARE THEN ACQUIRED THROUGH SEPARATE OPTICAL CHANNELS OF THE ENDOSCOPE AND ARE DIRECTED TO THE CAMERA HEAD AND PROCESSED INDEPENDENTLY. THE CAMERA CABLE CONNECTS THE CAMERA TO THE SYSTEM'S VISION CART, WHICH THEN TRANSMITS THE IMAGE TO THE SURGEON'S CONSOLE. THE SYSTEM ERROR CODE 45341 APPEARS WHEN THE DA VINCI S SAFETY SYSTEM DETERMINES THERE IS A LOSS OF SYNCHRONIZATION BETWEEN THE LEFT AND RIGHT VIDEO STREAMS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUT DA VINCI IN A RECOVERABLE SAFE STATE. THE CAMERA CABLE WAS INSPECTED BY THE FIELD SERVICE ENGINEER; HE WAS ABLE TO REPLICATE THE REPORTED FAILURE MODE AND OBSERVED THAT THERE WAS AN INTERNAL SHORT. THE SYSTEM WAS REPAIRED BY REPLACING THE DEFECTIVE CAMERA CABLE. FIELD SERVICE ENGINEER TESTED THE SYSTEM AND FOUND IT TO BE WORKING TO MANUFACTURER'S SPECIFICATIONS WITH NO DEFECT OR MALFUNCTION. THE CAMERA HEAD WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED PROBLEM, HOWEVER, THE CAMERA SHOWED EVIDENCE OF A MECHANICAL SHOCK. THE CAMERA WAS UPGRADED AS A PRECAUTION. FSE REVIEWED THE INTERNAL SYSTEM ERROR LOGS, AND HE ALSO IDENTIFIED ERROR CODE 23020 ASSOCIATED WITH THE PATIENT SIDE MANIPULATOR (PSM). SYSTEM ERROR CODE 23020 APPEARS WHEN THE DA VINCI SAFETY SYSTEM DETERMINES ONE OF THE SWITCHES IN A SPECIFIC MANIPULATOR IS SHOWING INCONSISTENT SIGNALS ON TWO SWITCH LEADS. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEM PUT DA VINCI IN A RECOVERABLE SAFE STATE. THE PSM WAS REPLACED AND RETURNED TO INTUITIVE SURGICAL FOR FURTHER INSPECTION. THE PATIENT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. THE PSM WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED PROBLEM; HOWEVER, THE CANNULA SWITCH, FLAT FLEX CABLE WERE REPLACED AS A PRECAUTION. THE CANNULA JUNCTION BOARD WAS ALSO UPGRADED. ON (B)(6) 2012 THE DA VINCI ROBOT COORDINATOR PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. SHE INDICATED THAT THE PLANNED SURGICAL PROCEDURE WAS CONVERTED TO OPEN DUE TO THE VISION ISSUE. SHE ALSO INDICATED THAT THE PATIENT REQUIRED 3 UNITS OF BLOOD; HOWEVER, SHE DIDN'T KNOW THE REASON. SHE INDICATED THAT THE PATIENT WAS RECOVERING WELL FROM THE OPEN PROCEDURE. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL." } ], "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": "" } ] }