{ "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": "2955842-2025-29555", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250714", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250312", "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", "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": "20250714", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20231027", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "215239", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250714", "brand_name": "DA VINCI", "generic_name": "SEAL", "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": "470500-13", "catalog_number": "470500", "lot_number": "N/A", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "GCJ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Laparoscope, General & Plastic Surgery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Material Fragmentation", "Material Fragmentation" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/12/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251104", "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": "20250714", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "78 YR", "patient_sex": "Female", "patient_weight": "62 KG", "patient_ethnicity": "Non Hispanic", "patient_race": "White", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250618", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22501344", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250618", "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": "374904814", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SEAL HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF IMAGES PROVIDED BY THE CUSTOMER WAS PERFORMED. THE IMAGES PROVIDED SHOWED TWO UNIVERSAL SEALS WITH TORN DUCKBILL COMPONENTS. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT #2955842-2025-29554 FOR MDR SUBMISSION INVOLVING A SIMILAR BUT DIFFERENT EVENT INVOLVING ANOTHER UNIVERSAL SEAL AND A FRAGMENT FALLING INSIDE THE PATIENT THAT WAS ALSO RETRIEVED. ADDITIONAL PATIENT INFORMATION: BODY MASS INDEX (BMI): 22.93 HEIGHT AND UNIT (CM/INCHES): 5¿5¿ CISGENDER." }, { "mdr_text_key": "374904818", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, A PORTION OF THE BLACK RUBBER OF A UNIVERSAL SEAL BROKE OFF AND FELL INSIDE THE PATIENT. A BLACK FOREIGN BODY PARTICLE WAS FOUND IN PATIENT'S PELVIS. THE BLACK PARTICLE WAS REMOVED AND THE PATIENT'S PELVIS WAS RE-EXAMINED TO ENSURE ALL FOREIGN BODIES WERE REMOVED FROM PATIENT. NO OTHER FRAGMENTS WERE FOUND INSIDE THE PATIENT. ONCE PARTICLE WAS OUTSIDE OF PATIENT. THE FRAGMENT WAS EXAMINED BY A TEAM MEMBER AND IT WAS CONFIRMED THAT THE PARTICLE CAME OFF OF A UNIVERSAL SEAL." }, { "mdr_text_key": "384265734", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE DA VINCI PRODUCTS TO PERFORM FAILURE ANALYSIS. UNIVERSAL SEAL #1 WAS FOUND TO HAVE A PIECE OF THE BLACK RUBBER DUCKBILL TORN. THE TORN PIECE WAS MISSING AND NOT RETURNED WITH THE SEAL. UNIVERSAL SEAL #2 WAS ANALYZED, AND THE FINDINGS DID NOT REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT. THERE WAS NO PHYSICAL DAMAGE FOUND TO THE SEAL. THE DUCKBILL WAS FULLY INTACT WITH NO TORN/MISSING PIECES. NO PRODUCT ISSUE WAS IDENTIFIED." }, { "mdr_text_key": "384265735", "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": "09/11/2025" } ] }