{ "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": "2955842-2025-45540", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251118", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250703", "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", "Foreign", "Distributor" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "IT", "manufacturer_contact_area_code": "408", "date_added": "20251118", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250916", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1088124", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251118", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Material Separation", "Material Separation" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251215", "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": "20251118", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20251118", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23580944", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251020", "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": "385378892", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS MCS (MCS) TIP COVER ACCESSORY CAME OFF THE INSTRUMENT AND FELL INTO A PATIENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS NOT INSPECTED PRIOR TO USE. THE MCS TIP COVER ACCESSORY WAS NOT RETRIEVED. THE SURGEON WAS MOVING THE MCS WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE PROCEDURE. THE MCS COLLIDED WITH ANOTHER INSTRUMENT DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE PROCEDURE, AND NO ORANGE SURFACE WAS VISIBLE WHEN INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED TO THE MCS PRIOR TO MCS TIP COVER ACCESSORY INSTALLATION. THERE WAS NO DIFFICULTY IN REMOVING THE MCS AND THE MCS TIP COVER ACCESSORY THROUGH THE CANNULA. THE INSTRUMENT WAS REMOVED WITH THE CANNULA, AND THE PORT INCISION WAS INCREASED IN ORDER TO REMOVE THEM. THE MCS WAS NOT STRAIGHTENED UPON REMOVAL, SINCE IT WAS BENT AND IT WAS NOT POSSIBLE TO STRAIGHTEN IT. THE MCS TIP COVER ACCESSORY IS NOT AVAILABLE FOR RETURN; HOWEVER, THE MCS IS AVAILABLE. AN IMAGE WAS PROVIDED FOR REVIEW." }, { "mdr_text_key": "385378893", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. REVIEW OF THE PROVIDED IMAGE WAS CONSISTENT WITH THE MCS BEING BENT. THE FAILURE MODE CANNOT BE CONFIRMED WITHOUT THE RETURNED DEVICE." } ], "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": "" } ] }