{ "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": "2955842-2024-19862", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240925", "manufacturer_address_2": "", "pma_pmn_number": "K182371", "date_of_event": "20240828", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "GM", "manufacturer_contact_area_code": "408", "date_added": "20240925", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240418", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1198761", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240925", "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": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "380941-50", "catalog_number": "N/A", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240912", "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": [ "Erratic or Intermittent Display", "Erratic or Intermittent Display" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/23/2024", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20240925", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Prefer Not To Disclose", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240828", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "20299962", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20240828", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "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": "352586481", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENDOSCOPE CONTROLLER (EC), REPLACED BY THE FIELD SERVICE ENGINEER (FSE), WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED. THIS UNIT WAS INSTALLED INTO THE TEST SYSTEM AND WENT THROUGH VIDEO TEST, 10 POWER CYCLES & SITTING IDLE FOR 1 HOUR WITH NO ISSUES. THE SYSTEM CAME UP WITH NO ERRORS AND HAD GOOD VIDEO ON BOTH EYES. THE EC WORKED AS NORMAL. THE SYSTEM LOGS FOR THIS PROCEDURE HAVE BEEN REVIEWED AND SEVERAL ERRORS ASSOCIATED WITH LOSS OF VIDEO SIGNAL CAN BE SEEN. THE ERRORS ARE CONSISTENT WITH INTERFERENCE CAUSED BY THE MONOPOLAR CABLE BEING TOO CLOSE TO THE ENDOSCOPE CABLE. THIS SITE HAS BEEN INFORMED THAT THEY NEED TO ROUTE THE TWO CABLES SEPARATELY TO AVOID INTERFERENCE." }, { "mdr_text_key": "352586482", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PROSTATECTOMY, THE NURSE CALLED THE TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THE IMAGE FROM THE ENDOSCOPE WAS FLICKERING ON THE VISION SIDE CART (VSC) AND THE SURGEON SIDE CONSOLE (SSC) AND THAT THIS IS THE THIRD ENDOSCOPE WITH THIS ISSUE. THE TSE ADVISED TO CLEAN THE ENDOSCOPE CONTROLLER (EC) AND CAMERA CONNECTOR WITH ETHANOL AFTER PROCEDURE, BUT THE NURSE INSISTED ON CLEAN THE EQUIPMENT WHILE PROCEDURE WAS ONGOING. AFTER THE CLEANING THE IMAGE WAS BETTER BUT STARTED TO FLICKER AGAIN AFTER A FEW SECONDS. UNRELATED TO THE IMAGE ISSUE, THERE WAS UNCONTROLLABLE BLEEDING AND THE SURGEON DECIDED TO CONVERT TO OPEN SURGERY TO ACHIEVE HEMOSTASIS. NO ADDITIONAL CLEANING OF EC AND CAMERA WAS PERFORMED. IT WAS LATER CLARIFIED IN FOLLOW UP WITH THE CLINICAL SALES REPRESENTATIVE (CSR), THAT THE PROCEDURE WAS CONVERTED BECAUSE THERE WAS NO RELIABLE ENDOSCOPE AVAILABLE, AND THE ISSUE COULDN¿T BE RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INTRAOPERATIVE COMPLICATION OR UNCONTROLLABLE BLEEDING AND THAT THIS WAS PURELY A TECHNICAL PROBLEM." }, { "mdr_text_key": "357003277", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION: ONE OF THE ENDOSCOPES USED IN THE PROCEDURE WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) WAS COMPLETED. FA CONFIRMED THE CUSTOMER REPORTED COMPLAINT ¿FLICKERING/INTERRUPTED PICTURE.¿ THE CAMERA WAS INSTALLED ON IN-HOUSE SYSTEM AND PASSED INITIALIZATION AND CALIBRATION TEST, HOWEVER, FAILED A FOCUS TEST. THOUGH THE INSTRUMENT PASSED, DURING EDT (ENDOSCOPE DIAGNOSTIC TEST), GRAINY IMAGES OCCURRED WHEN ARTICULATING THE WRIST. THE ENDOSCOPE ALSO PASSED AN AIR LEAK TEST. ADDITIONAL OBSERVATIONS RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE CAMERA WAS RETESTED A SECOND TIME AND FAILED TIP ARTICULATION. REVIEW OF THE LOGS SHOW A CAMERA TEMPERATURE SENSOR FAILURE, CAMERA COMMUNICATION ERROR, CAMERA POWER FAILURE, CAMERA POWER WARNING, LOSS OF IMAGE BOTH EYES (LOST SURGEON VIDEO), LOST SURGEON LEFT VIDEO, LOST SURGEON¿S RIGHT VIDEO, & VIDEO FROZEN. ADDITIONAL OBSERVATIONS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE CAMERA BUTTON PACK WAS FOUND TO HAVE MECHANICAL INDENTATION. THE BUTTON INVERT AND ILLUMINATION BUTTON HAD MECHANICAL INDENTATIONS ON THE BUTTON¿S EDGES." }, { "mdr_text_key": "357003278", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/14/2024" } ] }