{ "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": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2023-15437", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230601", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20201119", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230601", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200701", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1030309", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230601", "brand_name": "DA VINCI XI", "generic_name": "SURGEON SIDE CONSOLE, RECONDITIONED", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "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": "380723-09", "catalog_number": "380723", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201208", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874115374", "udi_public": "(01)00886874115374", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Optical Discoloration", "Optical Discoloration" ], "reporter_state_code": "MI", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250724", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "4085", "patient": [ { "patient_sequence_number": "1", "date_received": "20230601", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20201202", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17039776", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20201202", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "316386764", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR SURGICAL PROCEDURE, THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC) WAS BLUE. PRIOR TO CALL CUSTOMER TRIED ANOTHER SCOPE, NO CHANGE. TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED PERFORMING A HARD POWER CYCLE OF THE VISION SIDE CART (VSC) AND RESEATING THE FIBER CABLES, NO CHANGE. TSE RECOMMENDED TRYING A THIRD SCOPE, NO CHANGE. TSE RECOMMENDED REMOVING SCOPE AND CHECK THE SSC RIGHT EYE, RIGHT EYE WAS STILL BLUE IN SSC. TSE RECOMMENDED HARD POWER CYCLING THE SSC, NO CHANGE. TSE RECOMMENDED ANOTHER HARD POWER CYCLE OF THE SSC AND RESEATING THE FIBER CABLE, NO CHANGE. TSE RECOMMENDED BRINGING IN ANOTHER DA VINCI SSC. THE SURGEON OPTED TO CONVERT TO OPEN AND NEEDS TO END THE CALL. CTA CALLED BACK TO INFORM THAT THEY WERE ABLE TO GET ANOTHER SURGEON CONSOLE IN THE OR AND COMPLETE THE CASE. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: SURGEON PLACED PORTS. DOCKED THE X SYSTEM. SURGEON SAT DOWN AND NOTICED THE RIGHT EYE WAS SHOWING BLUE SCREEN. VISION TOWER TROUBLESHOOTING SHOWED THAT WE WERE GOOD TO GO. NO ERROR CODES APPEARED. SCOPE WAS SWAPPED. SYSTEM WAS RESTARTED TWICE, ONCE REGULAR POWER DOWN AND ONCE WITH THE BREAKERS. PROBLEM STILL OCCURRED. I CALLED DVSTAT (NO ON-SITE FOR THE SYSTEM) WE RAN THROUGH SEVERAL RESTARTS AND RECONNECTED FIBER OPTIC CORDS TO DIFFERENT LOCATIONS, THEN WE RECONNECTED THE SMALL CORD ON THE BACK OF THE VIDEO PROCESSOR. PROBLEM PERSISTED SO I GRABBED A SECOND CONSOLE FROM UPSTAIRS AND WE CONTINUED WITH THE SURGERY MINIMALLY INVASIVE ON THE X. SYSTEMS FUNCTIONALITY WERE CHECKED A FEW DAYS PRIOR WHEN WE DID A DRY RUN. THE SYSTEM WAS INITIALLY POWER ON WITHOUT ERRORS. THE SURGEON WAS ABLE TO SEE THROUGH THE HIGH RESOLUTION STEREO VIEWER (HRSV) AND GO INTO FOLLOWING MODE ONLY AFTER WE SWAPPED THE SURGEON CONSOLE." }, { "mdr_text_key": "316386765", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE FOUND RIGHT EYE BLUE IN SURGEON SIDE CONSOLE (SSC) WITH NO VISION ERRORS IN LOGS. FSE REPLACED PERSONALITY MODULE SURGEON CONSOLE (PMSC), RIGHT MONITOR AND SSC HIGH RESOLUTION STEREO VIEWER (HRSV) HARNESS TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PMSC WAS RETURNED FOR FAILURE ANALYSIS BUT THE REPORTED FAILURE COULD NOT REPRODUCED. THE ISI TECHICIAN WAS UNABLE TO REPRODUCE THE FAILURE REPORT BY INSTALLING THIS BOARD INTO PCA SI TEST SYSTEM. THEN, VIDEO TEST WAS GOOD VIDEO ON BOTH EYES WITH NO ANOMALIES. ADDITIONAL TEST PERFORMED: RUNNING 10 MINUTES SINE CYCLE, 20 POWER CYCLE AND SITTING IDLE FOR 3 DAYS HOUR WITHOUT ANY ERRORS AND GOOD VIDEO ON BOTH EYE. ACCORDING TO CASE NOTE, THERE WERE MULTI PARTS HAD BEEN REPLACED TO FIX THIS PROBLEM. THE HRSV-MONITOR WAS ALSO RETURNED AND FAILURE ANALYSIS INVESTIGATIONS CONFIRMED/REPLICATED THE REPORTED FAILURE. IT HAD ELECTRICAL AND FIBEROPTIC DEFECTS- COMPONENT OR MODULE ISSUE. THE FAILURE ATTRIBUTES TO COMPONENT FAILURE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }