{ "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": "2955842-2025-39846", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250930", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250901", "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_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "FR", "manufacturer_contact_area_code": "408", "date_added": "20250930", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250213", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2177111", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250930", "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": "400180-14", "catalog_number": "400180", "lot_number": "K12250213", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250924", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "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": [ "Detachment of Device or Device Component", "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251022", "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": "20250930", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "53 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Unspecified Tissue Injury", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20250901", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23181251", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250901", "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": "381344250", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY HAS BEEN RECEIVED A FOR FAILURE ANALYSIS EVALUATION. USING THE INSTALLATION TOOL, THE MCS TIP COVER ACCESSORY WAS PLACED ON A MCS INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM WITHOUT ANY ISSUE WITH THE MCS TIP COVER ACCESSORY. THE TIP COVER WAS TIGHTLY ATTACHED TO THE MCS INSTRUMENT AND COULD ONLY BE REMOVED WITH CONSIDERABLE EFFORT. NO PRODUCT ISSUE WAS IDENTIFIED." }, { "mdr_text_key": "381344251", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY THAT WAS INSTALLED ON AN MCS INSTRUMENT FELL OFF INSIDE THE PATIENT. THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE REPORTED. THE TIP COVER FELL INSIDE THE PATIENT DURING A DISSECTION, AND THE CAUSE OF ITS DETACHMENT IS UNKNOWN. IT HAD BEEN IN USE FOR 20 TO 30 MINUTES BEFORE THE INCIDENT, WITH NO ISSUES NOTICED IN THE SCISSORS' FUNCTIONALITY. THE TIP COVER APPEARED TO BE PROPERLY INSTALLED DURING THE PROCEDURE, WITH NO PART OF THE ORANGE SURFACE VISIBLE AFTER INSTALLATION, AND THE INSTALLATION TOOL WAS USED. NO ELECTROLUBE OR OTHER LUBRICANT WAS APPLIED TO THE MCS INSTRUMENT BEFORE INSTALLING THE TIP COVER, AND NO REDUCER WAS USED. THERE WAS NO COLLISION WITH OTHER INSTRUMENTS OR HARD MATERIALS DURING THE PROCEDURE. DURING REMOVAL OF THE MCS INSTRUMENT THROUGH THE CANNULA, NO RESISTANCE WAS FELT. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR ANY OTHER DAMAGE TO THE MCS INSTRUMENT AFTER THE INCIDENT. THE MCS TIP COVER ACCESSORY WAS RETRIEVED FOLLOWING A CONVERSION OF THE CASE TO A LAPAROTOMY. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO UNSPECIFIED OPERATIVE DIFFICULTIES AND AS A RESULT OF THE MCS TIP COVER ACCESSORY DETACHING FROM THE MCS INSTRUMENT. FUNCTIONAL TESTING OF THE MCS INSTRUMENT WAS PERFORMED WITHOUT ANOMALY. NO ADDITIONAL SURGICAL PROCEDURE WAS NECESSARY TO REMOVE THE MCS TIP COVER ACCESSORY. ADDITIONALLY, NO POSTOPERATIVE IMAGING TESTS, SUCH AS X-RAY OR ULTRASOUND, WERE PERFORMED TO CHECK FOR RETAINED FRAGMENTS. IT IS CURRENTLY UNKNOWN IF THE PATIENT HAS RETURNED TO THE HOSPITAL DUE TO POSTOPERATIVE COMPLICATIONS. THE MCS TIP COVER ACCESSORY HAS BEEN SET ASIDE AND HANDED OVER TO THE PHARMACY RESPONSIBLE FOR DEVICE VIGILANCE, AND IT WILL BE SENT TO INTUITIVE SURGICAL, INC. (ISI) FOR ANALYSIS." } ], "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": "" } ] }