{ "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": "2955842-2025-41267", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20251015", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250919", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "NURSE", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "UK", "manufacturer_contact_area_code": "408", "date_added": "20251015", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250116", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "48504", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251015", "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": "K16250116 0001", "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(10)K16250116", "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": "04/09/2026", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260504", "health_professional": "Y", "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": "20251015", "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": "20260430", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23303838", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250919", "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": "400003839", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "400003840", "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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS ANALYZED AND FOUND TO HAVE A TORN IN THE TRANSPARENT PART AT THE MOUTH WHERE THE SCISSOR TIPS EXIT, THE GREY PART DID NOT SHOW DAMAGE. AS RESULT OF THE TORN TIP COVER, THE FIT TEST FAILED. THE TEAR WAS NOT AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED 3.00MM IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. USING THE INSTALLATION TOOL, THE TIP COVER WAS PLACED ON A MCS INSTRUMENT. THE TIP COVER WAS TOO LOOSE ON THE SCISSORS AND COULD BE REMOVED WITH VERY LITTLE EFFORT. THE MCS INSTRUMENT REQUIRES THE USE OF A TIP COVER TO PREVENT ENERGY FROM DISCHARGING ANYWHERE BUT AT THE INSTRUMENT¿S TIP. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." }, { "mdr_text_key": "382624324", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "382624325", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY BECAME DETACHED FROM THE MCS INSTRUMENT. THE MCS TIP COVER ACCESSORY FELL INSIDE THE PATIENT BUT WAS RETRIEVED DURING THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED." } ], "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": "04/30/2026" } ] }