{ "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": "2955842-2026-16034", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260314", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260217", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "501", "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": "", "date_added": "20260314", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20251002", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "660984", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260314", "brand_name": "DA VINCI", "generic_name": "TIP COVER ACCESSORY", "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": "400180-16", "catalog_number": "400180", "lot_number": "K14251002", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260309", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)K14251002", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "", "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": "20260314", "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": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260314", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24600376", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260217", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "395597151", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "FAILURE ANALYSIS FOUND THE PRIMARY FINDING OF CANNOT VERIFY EXTERNAL EVENT TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE TIP COVER WAS PLACED ON AN IN-HOUSE GOLDEN MCS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH A FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE TIP COVER REMAINED TIGHTLY IN PLACE AND DID NOT FALL OFF. THE TIP COVER FITS COMPLETELY ON THE MCS, COVERING THE ORANGE TUBE EXTENSION. THERE WAS NO BULGE AT THE PROXIMAL END OF THE FIT. NO PRODUCT ISSUE WAS IDENTIFIED. ISSUES RELATED TO INSTRUMENT ERRORS OR COMPLICATIONS USING THE INSTRUMENT REPORTED BY THE USER WITH NO UNDERLYING PRODUCT ISSUE MAY BE RELATED TO CUSTOMER-INDUCED PROBLEMS, INCLUDING MISUSE OF THE PRODUCT AND RECOGNITION ISSUES." }, { "mdr_text_key": "395597152", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ROBOTIC HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY DETACHED FROM AN MCS INSTRUMENT AND FELL INSIDE THE PATIENT. THE CUSTOMER CONFIRMED THAT THE MCS TIP COVER ACCESSORY WAS NOT LOOSE AT THE TIME OF INSTALLATION. THE DETACHED MCS TIP COVER ACCESSORY WAS RETRIEVED USING A GRASPER, AND IT WAS CONFIRMED THAT NO RESIDUAL MATERIAL REMAINED IN THE PATIENT. THE CUSTOMER FURTHER REPORTED THAT THE MCS TIP COVER ACCESSORY HAD BEEN PROPERLY INSTALLED, WITH NO ORANGE SURFACE VISIBLE, AND THAT NO UNUSUAL COLLISIONS OR RESISTANCE WERE ENCOUNTERED DURING USE. FOLLOWING THE EVENT, NO DAMAGE WAS OBSERVED ON THE INSTRUMENT, ACCESSORY, OR CANNULA." } ], "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": "" } ] }