{ "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": "2955842-2025-49718", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251229", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20251205", "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": "PM", "manufacturer_contact_area_code": "408", "date_added": "20251230", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250501", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "185342", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251229", "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": "K15250501", "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)K15250501", "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": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260220", "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": "20251229", "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": "20251229", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "23918422", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20251205", "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": "388780663", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "AN INTUITIVE SURGICAL, INC. (ISI) PRODUCT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. AN IMAGE WAS PROVIDED OF THE TIP COVER ACCESSORY PACKAGING." }, { "mdr_text_key": "388780664", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) WERE BEING EXCHANGED FOR A LARGE NEEDLE DRIVER WHEN THE MCS TIP COVER ACCESSORY DETACHED AND FELL INTO THE CAVITY. THE MCS WAS REMOVED WITHOUT THE ACCESSORY, WHICH WAS LATER RETRIEVED THROUGH THE LAPAROSCOPIC ASSISTANT PORT. THE INSTRUMENT AND TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE, AND NO DAMAGE WAS NOTED; HOWEVER, THE OPERATING ROOM (OR) STAFF REPORTED MORE RESISTANCE THAN USUAL DURING INSTALLATION. THE ACCESSORY DETACHED DURING INSTRUMENT REMOVAL, AND THE SURGEON BELIEVES THE CAUSE WAS A MALFUNCTION OF THE TIP COVER ACCESSORY. THE MCS INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY TWO HOURS, AND NO ISSUES WITH ITS FUNCTIONALITY OR COLLISIONS WITH OTHER INSTRUMENTS WERE REPORTED. THE TIP COVER ACCESSORY APPEARED TO BE PROPERLY INSTALLED, WITH NO ORANGE SURFACE VISIBLE, NO OVER-INSTALLATION BEYOND THE ORANGE SURFACE, AND THE INSTALLATION TOOL WAS USED. THE ACCESSORY WAS MOISTENED WITH ROOM-TEMPERATURE WATER PRIOR TO INSTALLATION, AND NO REDUCER WAS USED. THERE WERE NO DIFFICULTIES DURING INSTRUMENT REMOVAL, AND THE WRIST WAS STRAIGHTENED UPON REMOVAL. NO DAMAGE WAS OBSERVED ON THE ACCESSORY, INSTRUMENT, OR CANNULA AFTER THE EVENT. THE PROCEDURE WAS COMPLETED ROBOTICALLY. FURTHER INFORMATION WAS OBTAINED THAT INDICATED DURING THE PROCEDURE SETUP, INCREASED RESISTANCE WAS NOTED DURING INSTALLATION, WHICH WAS NOT EXPECTED AND WAS CONSISTENT WITH IMPROPER ALIGNMENT OR INSTALLATION TECHNIQUE. THIS CONDITION WAS COMMUNICATED TO THE SURGEON PRIOR TO USE. THE DECISION WAS MADE TO PROCEED WITH THE PROCEDURE USING THE ACCESSORY. THE ADDED FRICTION LIKELY PREVENTED THE TIP COVER ACCESSORY FROM SEATING CORRECTLY AND CONTRIBUTED TO THE ACCESSORY DISENGAGING DURING INSTRUMENT REMOVAL. OTHER TIP COVERS FROM THE SAME LOT WERE EVALUATED AND THEY ALL PERFORMED AS INTENDED." } ], "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": "" } ] }