{ "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": "2955842-2024-23287", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20241223", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20241029", "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", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20241223", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20220208", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2626125", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241223", "brand_name": "DA VINCI", "generic_name": "ENDOSCOPE PLUS", "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": "470057-08", "catalog_number": "470057", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Visual Prompts will not Clear", "Visual Prompts will not Clear" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/21/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250808", "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": "20241223", "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", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20241127", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21001483", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20241127", "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": "359837179", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE ENDOSCOPE WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THEREFORE, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED." }, { "mdr_text_key": "359837180", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER RESECTION PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 KEPT FAULTING OUT. AN OPERATING ROOM (OR) STAFF MEMBER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE AFTER THEY HAD ALREADY CONVERTED THE CASE TO TRADITIONAL LAPAROSCOPIC SURGERY DUE TO THE SURGEON'S FRUSTRATIONS CAUSED BY THE FAULTS. THE TSE REVIEWED THE LOGS AND FOUND THE ENDOSCOPE KEPT GIVING AN ERROR. WHEN THE EVENT OCCURRED, THE CUSTOMER ELECTED NOT TO TRY AND USE ANOTHER ENDOSCOPE THAT THEY HAD IN THE ROOM. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER INDICATED THAT THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. ACCORDING TO THE INITIAL REPORTER, USM 2 WAS FUNCTIONAL AND THERE WAS NO ISSUE AFTER THE PROCEDURE. THE ENDOSCOPE WAS BEING RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "371583949", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE INSTRUMENT WAS ANALYZED, AND THE COMPLAINT WAS NOT CONFIRMED BY FAILURE ANALYSIS. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH ATTACHED ENDOSCOPE ADAPTER (AEA) DELRING DEGRADATION AND COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH BROKEN BOUSING. THE ENDOSCOPE WAS TESTED AND PLACED ON A CAMERA ATTENUATION TESTER OR EQUIVALENT TO MEASURE TRANSMITTANCE BUT FAILED FUNCTIONAL TESTING. THE ENDOSCOPE FAILED TRANSMITTANCE DUE TO THE MEASURED OUTPUT POWER NOT MEETING SPECIFICATION LIMITS. FURTHER FAILURE ANALYSIS INVESTIGATION WAS PERFORMED. THE ENDOSCOPE WAS DISASSEMBLED, AND THE CAMERA MODULE WAS VISUALLY INSPECTED AND PLACED ON AN INTERNAL TESTER AND FAILED. THE CAMERA MODULE FAILED NO IMAGE TEST." }, { "mdr_text_key": "371583950", "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": "06/03/2025" } ] }