{ "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": "2955842-2026-00498", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260112", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20251215", "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": "CA", "manufacturer_contact_area_code": "", "date_added": "20260112", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250313", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "100801", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260112", "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": "K19250313", "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)270331(10)K19250313", "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" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/13/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20260507", "health_professional": "Y", "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": "20260112", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "45 YR", "patient_sex": "Female", "patient_weight": "64 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260303", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24038533", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251216", "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": "389937929", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS." }, { "mdr_text_key": "389937930", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY SLIPPED OFF FROM THE MCS INSTRUMENT AND FELL INSIDE THE PATIENT WHILE PERFORMING THE COLPECTOMY. PRIOR TO USE, BOTH THE INSTRUMENT AND THE ACCESSORY WERE INSPECTED, AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. THE INSTALLATION TOOL WAS USED PROPERLY; NO PART OF THE ORANGE SURFACE WAS VISIBLE FOLLOWING INSTALLATION, AND THE ACCESSORY WAS NOT INSTALLED BEYOND THE INTENDED POSITION. THE CAUSE OF THE MCS TIP COVER ACCESSORY FALLING INSIDE THE PATIENT REMAINS UNDETERMINED. THE MCS INSTRUMENT WAS REMOVED, AND A THIRD-PARTY LAPAROSCOPIC GRASPER INSTRUMENT WAS USED TO RETRIEVE THE TIP COVER ACCESSORY. THE PELVIS WAS THOROUGHLY INSPECTED, TO CONFIRM THAT NOTHING REMAINED IN THE PATIENT. A NEW MCS TIP COVER ACCESSORY WAS INSTALLED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY. THE PATIENT DID NOT EXPERIENCE ANY POSTOPERATIVE COMPLICATIONS, AND THERE IS NO CONCERN ABOUT THIS EVENT CAUSING ANY LONG-TERM COMPLICATIONS." }, { "mdr_text_key": "394881251", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "394881252", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY FOR FAILURE ANALYSIS EVALUATION. THE MCS TIP COVER ACCESSORY WAS FOUND TO HAVE TEARING AT THE OPENING WHERE THE MCS INSTRUMENT TIPS EXIT. THE TEAR WAS AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED 0.118 INCHES IN LENGTH. THERE WAS NO EVIDENCE OF THERMAL DAMAGE, SUCH AS CHARRING OR MELTING, AT THE END OF ANY TEARS. A PIECE MEASURING BETWEEN 0.037 INCHES TO 0.045 INCHES WAS MISSING." } ], "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": "03/03/2026" } ] }