{ "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": "2955842-2023-18474", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230915", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20230821", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "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": "", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20230915", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20230525", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1039729", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230915", "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": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "400180-14", "catalog_number": "400180", "lot_number": "L81230525", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20230830", "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)L81230525", "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 Split, Cut or Torn", "Material Separation", "Material Split, Cut or Torn" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "", "date_changed": "20250821", "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": "20230915", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Foreign Body In Patient", "Foreign Body In Patient" ] } ], "distributor_city": "", "date_report": "20230823", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "17755007", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20230823", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "", "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": "323492318", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE WHEN THE SURGEON MOVED THE MONOPOLAR CURVED SCISSORS (MCS), THE MCS TIP COVER ACCESSORY FELL OFF OF THE SCISSORS. THE MCS TIP COVER WAS RETRIEVED AND REMOVED FROM INSIDE THE PATIENT. A NEW MCS TIP COVER WAS PLACED ON THE MCS INSTRUMENT, AND NO OTHER PROBLEMS WERE IDENTIFIED. THE PROCEDURE WAS COMPLETED.INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE MCS TIP COVER ACCESSORY WAS INSPECTED PRIOR TO USE, NO APPARENT DAMAGE WAS FOUND. THE BEDSIDE ASSISTANT USED A LAPAROSCOPIC GRASPER WHILE THE SURGEON USED HIS GRASPER TO HELP BRING IT WITHIN THE ASSISTANT'S REACH. DISSECTION WAS BEING PERFORMED WHEN THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT. NO FUNCTIONALITY ISSUES WERE FOUND. THE MCS INSTRUMENT DID NOT HAVE ANY COLLISIONS. A REDUCER WAS NOT USED. THERE WAS NO DIFFICULTY IN REMOVING THE MCS, OR THE TIP COVER. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. TINY HOLES WERE FOUND IN THE TIP COVER AFTER IT WAS REMOVED. THE INSTRUMENT WAS IN USE FOR APPROXIMATELY 30-45 MINUTES. ANOTHER TIP COVER WAS PLACED ON THE SCISSORS INSTRUMENT AND THE CASE WAS COMPLETED WITHOUT INCIDENT. THE NEW TIP COVER REPORTEDLY WENT ON VERY EASILY, ALMOST AS IF IT WAS LOOSE. THE ORIGINAL TIP COVER WAS INSTALLED CORRECTLY. THE ORANGE SURFACE WAS NOT VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. LUBRICANT WAS NOT USED DURING TIP COVER INSTALLATION. THE TIP COVER WAS RETURNED FOR FAILURE ANALYSIS. THE MCS INSTRUMENT WAS NOT AVAILABLE FOR RETURN. THERE WERE NO VIDEOS OR IMAGES AVAILABLE." }, { "mdr_text_key": "323492323", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FELL OFF OF THE INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MCS TIP COVER ACCESSORY WAS ANALYZED AND FOUND TO HAVE TEARING AT THE MOUTH. TEARS ALIGNED WITH THE TIP COVER AND MEASURED FROM 0.104¿ TO 0.010¿ IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE COMPLAINT REGARDING THE MCS TIP COVER WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED COMPLAINT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "408", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }