{ "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": "2955842-2025-15924", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250418", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250324", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250418", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240411", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2255207", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250418", "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": "L81240411", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(17)260430(10)L81240411", "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": "05/08/2020", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250418", "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", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250325", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21864403", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250325", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "370750334", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "370750335", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 08-MAY-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE TIP COVER ACCESSORY WAS EVALUATED BY FAILURE ANALYSIS AND FOUND TO HAVE GOUGES ON THE OUTER SURFACE OF THE TIP COVER. THE GOUGES WERE NOT AXIALLY ALIGNED. THERE WAS NO MATERIAL FOUND MISSING. THE ACCESSORY APPEARED LOOSELY PLACED IN THE MCS BUT DID NOT COME OFF NATURALLY WHEN PLACED IN THE IN-HOUSE SYSTEM." }, { "mdr_text_key": "368424448", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AFTER THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT. IT WAS REATTACHED BUT WAS LOOSE. THERE WAS NO DISCOMFORT THE FIRST TIME IT WAS PUT ON. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE NOTED. THE SURGICAL TASK BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT WAS DISSECTION. THE SURGEON WAS UNAWARE OF WHY THE MCS TIP COVER CAME OFF BUT THOUGHT IT WAS DANGEROUS. THE INSTRUMENT WAS IN USE FOR ABOUT AN HOUR. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FULL FUNCTIONALITY OF THE INSTRUMENT. IT IS POSSIBLE THAT THE INSTRUMENT COLLIDED WITH ANOTHER INSTRUMENT. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE. NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS INSTALLED BEYOND THE ORANGE SURFACE. THE CUSTOMER USED AN INSTALLATION TOOL. NO ELECTROLUBE WAS APPLIED TO THE MCS INSTRUMENT PRIOR TO THE TIP COVER ACCESSORY INSTALLATION. NO REDUCER WAS USED; THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT MCS TIP COVER ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. NO DAMAGE WAS FOUND ON THE MCS TIP COVER ACCESSORY OR THE INSTRUMENT, BUT WHILE REPLACING THE TIP COVER ACCESSORY IT WAS NOTED IT CAME LOOSE. A NEW TIP COVER ACCESSORY COULD BE FITTED WITHOUT ANY PROBLEMS AND DID NOT COME OFF. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE MCS TIP COVER ACCESSORY WAS AVAILABLE FOR RETURN TO ISI. THE INSTRUMENT IS ALSO AVAILABLE FOR RETURN TO ISI. THERE WERE NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR A VIDEO RECORDING OF THE PROCEDURE AVAILABLE." }, { "mdr_text_key": "368424449", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE." } ], "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": "05/21/2025" } ] }