{ "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": "2955842-2025-04225", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250305", "manufacturer_address_2": "", "pma_pmn_number": "K112263", "date_of_event": "20250206", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "408", "date_added": "20250305", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "901399", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250305", "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", "catalog_number": "400180", "lot_number": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/26/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250305", "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": "20250206", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21526611", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250206", "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": "365026396", "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 FELL OFF OF THE INSTRUMENT AND INTO THE PATIENT. THE MCS TIP COVER 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 MCS INSTRUMENT AND THE MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS NOTED. THE MCS TIP COVER ACCESSORY WAS RETRIEVED WITH A LAPAROSCOPIC GRASPER. IT IS UNKNOWN WHAT SURGICAL TASK WAS BEING PERFORMED WHEN THE MCS TIP COVER FELL INSIDE OF THE PATIENT. THE MCS INSTRUMENT WAS IN USE FOR APPROXIMATELY 30 MINUTES. THE SURGEON DID NOT NOTICE ANY ISSUES WITH FUNCTIONALITY OF THE INSTRUMENT DURING THE PROCEDURE. THE MCS TIP COVER INSTRUMENT DID NOT COLLIDE WITH ANY OTHER HARD MATERIAL OR INSTRUMENTS. IT DID APPEAR THAT THE MCS TIP COVER WAS INSTALLED PROPERLY DURING THE SURGICAL PROCEDURE. THERE WAS NO ORANGE SURFACE VISIBLE AFTER THE MCS TIP COVER WAS INSTALLED. THE COVER WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE CUSTOMER INSTALLED THE TIP COVER WITH THE INSTALLATION TOOL. NO ELECTROLUBE OR OTHER LUBRICANT WAS USED DURING INSTALLATION OF THE MCS TIP COVER. THERE WAS NO REDUCER USED. IT WAS NOT DIFFICULT TO REMOVE THE INSTRUMENT AND MCS TIP COVER ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON THE REMOVAL. THE SURGICAL STAFF DID NOT NOTICE ANY DAMAGE TO THE MCS TIP COVER ACCESSORY, INSTRUMENT, OR CANNULA AFTER THE EVENT OCCURRED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. THERE ARE NO PHOTOGRAPHIC IMAGES OR VIDEO RECORDING AVAILABLE FOR ISI REVIEW." }, { "mdr_text_key": "365026397", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY PRODUCT FOR FAILURE ANALYSIS EVALUATION. A MONOPOLAR CURVED SCISSORS INSTRUMENT WAS RETURNED WITH NO PRODUCT ISSUE IDENTIFIED. THE EVENT INVESTIGATION IS IN PROGRESS." }, { "mdr_text_key": "366693417", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAS BEEN RETURNED FOR FAILURE ANALYSIS EVALUATION. HOWEVER, THE MCS TIP COVER ACCESSORY WAS NOT RETURNED WITH THE INSTRUMENT. THE MCS INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM WITH AN IN-HOUSE MCS TIP COVER ACCESSORY TO TEST THE PERFORMANCE. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. A VISUAL INSPECTION FOUND NO DAMAGE ON THE DISTAL END THAT COULD HAVE CONTRIBUTE TO THE TIP COVER ACCESSORY TO FALL. NO PRODUCT ISSUE WAS IDENTIFIED." }, { "mdr_text_key": "366693418", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." } ], "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": "03/25/2025" } ] }