{ "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": "2955842-2025-50506", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260112", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20251209", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "AS", "manufacturer_contact_area_code": "", "date_added": "20260113", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250828", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "110384", "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": "K13250828", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "10886874111045", "udi_public": "(01)10886874111045(10)K13250828", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260209", "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": "20260112", "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": "20260112", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24047573", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251217", "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": "390023633", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MCS TIP COVER ACCESSORY HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. CONCOMITANT PRODUCT(S): MCS INSTRUMENT (PART #470179)." }, { "mdr_text_key": "390023634", "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 MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS PLACED SECURELY ON THE MCS INSTRUMENT PRIOR TO USE. WHEN REMOVING THE INSTRUMENT, THE MCS TIP COVER ACCESSORY FELL OFF INSIDE THE PATIENT'S ABDOMEN. THE MCS TIP COVER ACCESSORY WAS REMOVED FROM PATIENT DURING THE SAME SURGICAL PROCEDURE AND A NEW TIP COVER WAS INSTALLED ON THE MCS INSTRUMENT. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: BOTH THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS OBSERVED AT THAT TIME. DURING THE PROCEDURE, THE MCS TIP COVER ACCESSORY WAS RETRIEVED USING THE ASSISTANT PORT AND A LAPAROSCOPIC TOOL. THE SURGEON WAS UNSURE OF WHAT CAUSED THE ACCESSORY TO SLIP OFF OR BREAK AND DID NOT OBSERVE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE TEAM WAS ALSO UNAWARE OF ANY COLLISIONS BETWEEN THE MCS INSTRUMENT AND OTHER INSTRUMENTS DURING THE PROCEDURE. THE MCS TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED AND NO PART OF THE ORANGE SURFACE WAS VISIBLE. THERE WAS NO DIFFICULTY IN REMOVING THE MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY, AND THE INSTRUMENT'S WRIST WAS STRAIGHTENED UPON REMOVAL. FOLLOWING THE EVENT, THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE MCS TIP COVER ACCESSORY, THE MCS INSTRUMENT, OR THE CANNULA. THE PROCEDURE WAS COMPLETED ROBOTICALLY." } ], "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": "" } ] }