{ "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": "2955842-2025-33097", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250808", "manufacturer_address_2": "", "pma_pmn_number": "K171426", "date_of_event": "20250716", "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": "CH", "manufacturer_contact_area_code": "", "date_added": "20250808", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20211012", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "50179", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250808", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE", "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": "470027-64", "catalog_number": "470027", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Erratic or Intermittent Display", "Erratic or Intermittent Display" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/17/2025;05/14/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "Y", "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": "20250808", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions", "Unspecified Tissue Injury", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260603", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22758808", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250717", "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": "377266846", "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 EVENT. BASED ON THE FIELD EVALUATION, THE FSE WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED ISSUE. NO PRODUCTS WERE REPLACED OR ADJUSTED BY THE FSE. NO DEVICE HAS BEEN RETURNED FOR FAILURE ANALYSIS EVALUATION. ." }, { "mdr_text_key": "377266847", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE NURSE INDICATED THAT THE IMAGE WAS FLICKERING. THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) FOR ASSISTANCE. THE TSE GUIDED THE CUSTOMER WITH RESEATING THE ENDOSCOPE. THE CUSTOMER STATED THAT HE HAD TRIED THAT BUT THE ISSUE REMAINED. THE TSE THEN GUIDED THE CUSTOMER WITH REPLACING THE ENDOSCOPE. THE CUSTOMER REPLIED THAT THERE WERE LOTS OF PROCEDURES TODAY AND HE WAS NOT ABLE TO TRY A BACKUP ENDOSCOPE. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY." }, { "mdr_text_key": "403361399", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED: G3, G6, H2, H11, ANNEX E, ANNEX F, ANNEX G, ANNEX D. AN ADDITIONAL FAILURE ANALYSIS WAS PERFORMED ON THE ENDOSCOPE. THE FOCUS OF ENDOSCOPE WAS TESTED ON A SYSTEM OR EQUIVALENT AND FOUND TO FAIL THE FOCUS TEST. THE ENDOSCOPE WAS FOUND WITH FLICKERING/ROLLING IMAGE. ADDITIONALLY, THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE ENDOSCOPE WAS PLUGGED ON IN-HOUSE SYSTEM OR EQUIVALENT AND PROVIDED COLOR BARS IN BOTH EYES. THE ENDOSCOPE WAS FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER WAS REMOVED FROM ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH AEA SHAFT BEARING CONTRIBUTING TO FRICTION. THE ENDOSCOPE WAS TESTED AND PLACED ON IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE IN-HOUSE SYSTEM OR EQUIVALENT FAILED TO COMMUNICATE WITH THE ENDOSCOPE, RESULTING IN AN ERROR MESSAGE CHECK ENDOSCOPE CABLE CONNECTION/ENDOSCOPE SELF - TEST FAILED. A REVIEW OF THE PROVIDED VIDEO WAS PERFORMED. THE VIDEO SHOWS A FLICKERING IMAGE, CAUSING A SHORT DISRUPTION. ADDITIONAL INFORMATION: THE PROCEDURE WAS COMPLETED ROBOTICALLY AND WAS NOT CONVERTED TO OPEN SURGERY, AS INITIALLY REPORTED." }, { "mdr_text_key": "403361400", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "386403395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "386403396", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE ENDOSCOPE WAS RECEIVED AND FAILURE ANALYSIS. THE ENDOSCOPE WAS TESTED AND PLACED ON AN IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING AND FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE IN-HOUSE SYSTEM OR EQUIVALENT FAILED TO COMMUNICATE WITH THE ENDOSCOPE, RESULTING IN AN ERROR MESSAGE INDICATING THE SELF-TEST FAILED. THE ENDOSCOPE PROVIDED COLOR BARS IN BOTH EYES. THE ENDOSCOPE WAS EVALUATED AND FOUND WITH A CAMERA INSTRUMENT ADAPTER DEFECT. THE ENDOSCOPE WAS PLACED THROUGH FRICTION TEST USING A SCREENING AIDE TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. THE CAMERA INSTRUMENT ADAPTER WAS REMOVED FROM THE ENDOSCOPE HOUSING AND EVALUATED AND FOUND WITH A SHAFT BEARING ISSUE CONTRIBUTING TO FRICTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/12/2025;06/03/2026" } ] }