{ "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": "2955842-2026-21283", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260413", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20260310", "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": "", "date_added": "20260413", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250403", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "918724", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260413", "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": "K15250403 NA", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20260409", "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)K15250403", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Separation" ], "reporter_state_code": "", "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": "20260413", "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": "20260413", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24859356", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260323", "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": "398313089", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE REPORTED EVENT WITH THE TIP COVER ACCESSORY COULD NOT BE REPLICATED NOR CONFIRMED. USING THE INSTALLATION TOOL, THE TIP COVER WAS PLACED ON A MONOPOLAR CURVED SCISSOR INSTRUMENT. THE TIP COVER WAS TIGHTLY ATTACHED TO THE SCISSOR AND COULD ONLY BE REMOVED WITH CONSIDERABLE EFFORT. NO PRODUCT ISSUE WAS IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, CUSTOMER REPORTED ISSUES MAY BE DUE TO OTHER FACTORS UNRELATED TO THE PRODUCT." }, { "mdr_text_key": "398313090", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FORCEPS WERE PROPERLY FITTED, BUT WHEN THE SCISSORS WERE REMOVED FROM THE PORT, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY CAME OFF AND REMAINED INSIDE THE PORT. IT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: DURING THE SURGICAL EVENT, IT REMAINS UNKNOWN HOW THE MCS TIP COVER ACCESSORY WAS RETRIEVED, WHETHER THE MCS INSTRUMENT COLLIDED WITH OTHER INSTRUMENTS, IF ANY LUBRICANT WAS APPLIED BEFORE INSTALLATION, WHETHER THERE WAS DIFFICULTY IN REMOVAL, WHETHER THE INSTRUMENT WRIST WAS STRAIGHTENED PRIOR TO REMOVAL, OR IF ANY IMMEDIATE DAMAGE WAS OBSERVED ON THE ACCESSORY, INSTRUMENT, OR CANNULA. HOWEVER, IT WAS NOTED THAT THE TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO PART OF ITS ORANGE SURFACE VISIBLE AFTER INSTALLATION, WHICH IS CONSISTENT WITH RECOMMENDED PRACTICE FOR ENSURING ELECTRICAL INSULATION AND SAFETY. THE TIP COVER ACCESSORY HAS BEEN RETURNED TO INTUITIVE SURGICAL FOR FURTHER EVALUATION, THOUGH THE ACCOMPANYING MCS INSTRUMENT WAS NOT SENT BACK. NO FRAGMENT WAS NOTICED." } ], "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": "" } ] }