{ "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": "2955842-2025-28928", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250709", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250609", "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": "408", "date_added": "20250709", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241107", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "583268", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250709", "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": "K12241107", "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)K12241107", "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": "07/09/2025", "mfr_report_type": "Follow-Up", "manufacturer_contact_country": "US", "date_changed": "20250731", "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": "20250709", "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": "20250619", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22457881", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250619", "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": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "375079515", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "375079516", "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 TEARING AT THE MOUTH WHERE THE SCISSOR TIPS EXIT. THE TEARS WERE AXIALLY ALIGNED WITH THE TIP COVER AND MEASURED FROM 0.078\" TO 0.080\" IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS. THE MCS INSTRUMENT REQUIRES THE USE OF A TIP COVER TO PREVENT ENERGY FROM DISCHARGING ANYWHERE BUT AT THE INSTRUMENT¿S TIP. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS." }, { "mdr_text_key": "374471875", "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": "374471876", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED, LAPAROSCOPIC RENAL MALIGNANCY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS), WHICH HAD NO GAPS IN THE ACCESSORIES, WERE REMOVED. AFTER THE TROCAR WAS REMOVED, A PAIR WAS INSERTED THROUGH THE WOUND WHERE THE MCS TIP COVER ACCESSORY REMAINED IN THE CAMERA FIELD OF VIEW. THE MCS TIP COVER ACCESSORY 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: THE INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE NOT INSPECTED PRIOR TO USE, SO NO DAMAGE WAS NOTED. THE MCS TIP COVER WAS RETRIEVED AFTER REMOVING THE CANNULA. TO REMOVE THE FRAGMENT THE CUSTOMER INSERTED FORCEPS INTO THE WOUND. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED AT THE TIME OF THE MCS TIP COVER FALLING INTO THE PATIENT. IT IS UNKNOWN FOR HOW LONG THE INSTRUMENT AND THE ACCESSORY WERE IN USE; HOWEVER, THE SURGEON NOTICED RESISTANCE WHEN INSERTING THE MCS. IT IS UNKNOWN IF THE MCS INSTRUMENT COLLIDED WITH ANY OTHER INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER APPEARED TO BE INSTALLED FINE BEFORE THE ISSUE. NO ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER WAS INSTALLED. IT IS UNKNOWN IF THE MCS TIP COVER WAS INSTALLED BEYOND THE ORANGE SURFACE. IT IS UNKNOWN IF THE INSTALLATION TOOL WAS USED. IT IS UNKNOWN IF A REDUCER WAS USED. IT IS UNKNOWN IF THE INSTRUMENT'S WRIST WAS STRAIGHTENED UPON REMOVAL. THE STAFF NOTICED THE MCS TIP COVER ACCESSORY WAS DEFORMED AFTER REMOVING IT. THE APPEARANCE OF THE MCS WAS FINE AND THE CANNULA WAS TESTED WITH THE GAUGE PIN, AND NO ISSUES WERE NOTED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THE MCS TIP COVER ACCESSORY IS AVAILABLE FOR RETURN, HOWEVER, THE INSTRUMENT IS NOT. PHOTOGRAPHIC IMAGES OF THE DEVICE OR VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR REVIEW." } ], "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": "07/16/2025" } ] }