{ "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": "2955842-2023-17157", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20230719", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20230627", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230719", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230124", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "39468", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230719", "brand_name": "DA VINCI SP", "generic_name": "VISION SYSTEM CART", "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": "380941-45", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230707", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874114742", "udi_public": "(01)00886874114742", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Optical Distortion", "Optical Distortion" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "07/19/2023;08/24/2023", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "", "date_changed": "20250819", "health_professional": "Y", "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": "20230719", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20230627", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17350367", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230627", "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": "336888158", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENDOSCOPE CONTROLLER (EC) WAS FURTHER INVESTIGATED AND THE CONNECTOR OF THE DUAL CAMERA INTERFACE BOARD BOARD IN THE EC WAS CONFIRMED DAMAGED." }, { "mdr_text_key": "336888159", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "336897234", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H10/H11 FOR FOLLOW-UP INFORMATION. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FOLLOW-UP: ON (B)(6) 2023, THE ROBOTIC COORDINATOR INFORMED AFTER TALKING WITH THE TEAM THAT ALTHOUGH THEY WERE PLANNING TO CONTINUE THE PROCEDURE ON XI THEY OPTED TO WAIT FOR THE SP CAMERA FROM THE STERILE PROCESSING DEPARTMENT. THE CASE WAS DELAYED BUT IT WAS FINISHED USING THE SP ROBOT. THE CAMERA WORKED THAT'S WHY THEY WERE ABLE TO GO ON WITH THE SAID PROCEDURE." }, { "mdr_text_key": "336897295", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE SINGLE-PORT FIREFLY CAMERA TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM BUT WAS NOT ABLE TO REPRODUCE THE REPORTED COMPLAINT. THE CAMERA WAS FOUND TO HAVE FAILED DURING INITIALIZATION BASED ON LOG REVIEW. THE LOG REVIEW CAPTURED THE FOLLOWING ERRORS: 48216 (CAMERA TEMPERATURE SENSING NOT RESPONDING), 48221 (DUAL CAMERA INTERFACE BOARD COMMUNICATION ERROR), 48225 (POWER FAILURE), 48229 (POWER WARNING), AND 48406 (WATCHDOG TIMEOUT IN ILLUMINATOR). THE CAMERA WAS PLACED ON THE IN-HOUSE SYSTEM AND SUCCESSFULLY PASSED THE QAP TEST (QUALITY ASSURANCE PROCEDURE). ADDITIONALLY, IT PASSED BOTH ENDOSCOPE DIAGNOSTICS TESTS (EDT). NO DAMAGE WAS FOUND." }, { "mdr_text_key": "319337845", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE WENT TO COLOR BARS AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. DURING INITIAL TROUBLESHOOTING, BOTH ENDOSCOPES WERE PROVIDED FOR TESTING. THE FIRST ENDOSCOPE SHOWED VISUAL ISSUES WITH FLICKERING LINES ACROSS THE SCREEN. THE SECOND ENDOSCOPE SHOWED SIMILAR ISSUES THOUGH NOT AS SEVERE. THE FSE REPLACED THE ENDOSCOPE CONTROLLER (EC) AND RETESTED THE ENDOSCOPES. THE FIRST ENDOSCOPE TESTED WITH SEVERE FLICKERING AND WAS FOUND TO BE NON-OPERATIONAL AT THAT POINT. THE SECOND ENDOSCOPE WAS ABLE TO CONNECT AND HAD NO FURTHER ISSUES. A THIRD ENDOSCOPE WAS BROUGHT IN FROM PROCESSING AND TESTED AND FOUND TO BE OPERATING AS NORMAL WITH THE NEW EC AS WELL. THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE EC WAS ANALYZED, AND FA WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM, AND IT FAILED DURING VIDEO TEST. THE IMAGE WAS FLICKERING AND TURN TO COLOR BARS. THE LIGHT ENGINE WAS THE CAUSE THE ISSUE AND WILL BE REPLACED TO CORRECT THE ISSUE. THE COMPLAINT REGARDING IMAGE ISSUES WAS CONFIRMED BY FA, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE." }, { "mdr_text_key": "319337846", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT THEIR IMAGE WENT TO COLOR BARS. PRIOR TO CALLING THE CUSTOMER STATED THEY HAD THIS ISSUE EARLIER AND CHANGED TO ANOTHER CAMERA, BUT THE ISSUE RETURNED. THE CUSTOMER STATED THEY DID NOT HAVE ANY MORE CAMERAS SNICE THE REMAINING CAMERAS WERE BEING REPROCESSED. THE TSE ASSISTED THE CUSTOMER THROUGH A HARD POWER OF THE VISION SIDE CART. THE SYSTEM POWERED ON WITHOUT ERROR. THE TSE THEN CUSTOMER INSTALLED THE CAMERA AGAIN, BUT THE CAMERA FAILED SELF-TEST. THE CUSTOMER ONLY HAD ONE CAMERA AVAILABLE. THE CUSTOMER HAS DECIDED TO MOVE AN XI SYSTEM INTO THE ROOM TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS CONVERTED FROM A SINGLE-PORT SYSTEM TO AN XI DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." } ], "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": "08/09/2023;09/15/2023" } ] }