{ "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": "2955842-2025-01726", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250225", "manufacturer_address_2": "", "pma_pmn_number": "K131861", "date_of_event": "20241211", "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": "20250225", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20200305", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1992586", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250225", "brand_name": "DA VINCI", "generic_name": "CANNULA, STANDARD, REUSABLE", "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": "470002-08", "catalog_number": "470002", "lot_number": "VE200701", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250124", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "00886874112137", "udi_public": "(01)00886874112137(10)VE200701", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "WV", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20250225", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "71 YR", "patient_sex": "Female", "patient_weight": "80 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20250128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21461411", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250128", "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": "364380936", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CANNULA TO PERFORM FAILURE ANALYSIS. THE CANNULA WAS ANALYZED AND FOUND TO HAVE SCRATCH MARK DAMAGE AT THE DISTAL END OF THE CANNULA. THE SCRATCH MARKS WERE LOCATED INSIDE OF THE DARK GREY INK STRIP AT THE BOTTOM OF THE CANNULA. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ISI ALSO RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE SCRATCHES ON THE MAIN TUBE. THE INSTRUMENT WAS FOUND TO HAVE VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVED ON THE MAIN TUBE. THE INSTRUMENT WAS RETURNED WITH THE CORD CUT SO THE INSTRUMENT WAS NOT ABLE TO BE TESTED FOR SEALING/CUTTING FUNCTIONALITY. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED RECOGNITION AND ENGAGEMENT TESTS AND MOVED INTUITIVELY THROUGH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. A SEPARATE MEDWATCH REPORT (MDR) WITH MFR REPORT #2955842-2024-24002 WAS SUBMITTED FOR THE VESSEL SEALER EXTEND (VSE) INSTRUMENT METAL SHAVINGS THAT HAD COME OFF INSIDE THE PATIENT AND X-RAY THAT WAS PERFORMED." }, { "mdr_text_key": "364380937", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA REPAIR PROCEDURE, THE COATING/METAL SHAVINGS ON SHAFT OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT SCRAPED OFF AND FELL INSIDE THE PATIENT'S ABDOMEN. THE INTUITIVE SURGICAL, INC. (ISI) CUSTOMER SALES REPRESENTATIVE (CSR) THAT WAS PRESENT DURING THE PROCEDURE STATED THAT THE SURGEON WAS ABLE TO REMOVE MOST OF THE METAL SHAVINGS. IT IS UNKNOWN IF ALL THE SHAVINGS WERE RETRIEVED. A POST OPERATIVE X-RAY WAS PERFORMED BUT THE RESULTS OF THE X-RAY ARE UNKNOWN. THE SURGEON REPORTED THAT THE PATIENT HAS NOT RETURNED WITH ANY POST-OPERATIVE COMPLICATIONS." } ], "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": "" } ] }