{ "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": "2955842-2025-38976", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20250929", "manufacturer_address_2": "", "pma_pmn_number": "K191736", "date_of_event": "20250829", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250929", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230823", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2308125", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250929", "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", "date_returned_to_manufacturer": "20250919", "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": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "10/13/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260209", "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": "20250929", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20251105", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23175894", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250902", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "381290447", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ENDOSCOPE PLUS INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE." }, { "mdr_text_key": "381290448", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, AN ENDOSCOPE PLUS STOPPED WORKING AND A FRAGMENT FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED ROBOTICALLY." }, { "mdr_text_key": "387777349", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "387777350", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H3, H6, AND H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE 30 DEGREE ENDOSCOPE PLUS TO PERFORM FAILURE ANALYSIS. THE ENDOSCOPE WAS TESTED AND PLACED ON AN IN-HOUSE SYSTEM OR EQUIVALENT FOR FUNCTIONAL TESTING. THE ENDOSCOPE FAILED TO PROVIDE A VIDEO DUE TO AN ELECTRICAL OR COMMUNICATION FAILURE. THE ENDOSCOPE REPORTEDLY PROVIDED COLOR BARS IN EITHER THE RIGHT EYE OR BOTH EYES. THE ENDOSCOPE CAMERA INSTRUMENT ADAPTER WAS VISUALLY INSPECTED, AND MECHANICAL DAMAGE WAS FOUND IN THE IDLER GEAR BEARING. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. THE CABLE INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. THE ENDOSCOPE CABLE INTEGRATED CONNECTOR WAS VISUALLY INSPECTED AND FOUND WITH MECHANICAL DAMAGE. THE CABLE INTEGRATED CONNECTOR PADDLEBOARD EXHIBITED MECHANICAL DAMAGES SUCH AS SCRATCH MARKS, INDENTATIONS OR BROKEN OR MISSING PIECES LOCATED AT CABLE PROXIMAL END. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED IN THE MIDDLE 1/3 OF THE ENDOSCOPE CABLE. THE ENDOSCOPE HOUSING SHELL EXHIBITED LASER MARKING THAT WAS FADING AND/OR REMOVED. CONTAMINATION WAS ALSO FOUND AT THE DISTAL TIP OF THE ENDOSCOPE. THE ENDOSCOPE WAS TESTED AND PLACED ON A DIAGNOSTIC TESTER OR EQUIVALENT BUT FAILED FUNCTIONAL TESTING DUE TO AN ELECTRICAL FAILURE. THE DIAGNOSTIC TESTER RESULT EXHIBITED A VOLTAGE ISSUE DUE TO EXPECTED RANGE NOT BEING MET. THE ENDOSCOPE WAS PLACED ON AN IN-HOUSE DIAGNOSTIC TESTER OR EQUIVALENT AND FOUND WITH LOCAL BUTTON CONTROLS NOT WORKING PROPERLY. THE ENDOSCOPE WAS TESTED AND PLACE ON AN IN-HOUSE SYSTEM FOR CABLE TESTING AND FAILED DUE TO WAHOO PADDLE BOARD (WPB) DEFECT." } ], "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": "11/05/2025" } ] }