{ "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": "2955842-2025-01012", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250205", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250108", "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": "20250205", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240913", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1516512", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250205", "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": "U80240913", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20250115", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "10886874116408", "udi_public": "(01)10886874116408(10)U80240913", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "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": "20250205", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES." ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "36 YR", "patient_sex": "Female", "patient_weight": "127 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": "20250108", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21317870", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250108", "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": "362982064", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SEAL FOR FAILURE ANALYSIS EVALUATION. THE UNIVERSAL SEAL WAS ANALYZED AND FOUND TO HAVE TEARING AT THE DUCKBILL. THE TEARS WERE NOT AXIALLY ALIGNED WITH THE SEAL AND MEASURED FROM 0.170¿ TO 0.214¿ IN LENGTH. THERE WERE NO SIGNS OF THERMAL DAMAGE PRESENT AT THE END OF ANY TEARS." }, { "mdr_text_key": "362982065", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A PIECE OF NON-ORGANIC MATERIAL WAS FOUND INSIDE THE PATIENT. THE PIECE WAS REMOVED AND IDENTIFIED AS A FRAGMENT FROM A UNIVERSAL SEAL FOR A CANNULA. AFTER COMPLETION OF THE PROCEDURE, THE CUSTOMER VERIFIED THAT THE REMOVED FRAGMENT WAS FROM ONE OF THE UNIVERSAL SEALS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE UNIVERSAL SEAL WAS INSPECTED PRIOR TO USE AND NO ISSUES WERE NOTED. THE FOREIGN BODY WAS NOTICED WHILE TISSUE WAS BEING RETRACTED BY THE CUSTOMER. THE INSTRUMENTATION WORKED FINE DURING THE CASE. NO DEVICE COLLISIONS WERE NOTED DURING THE CASE. THE STAFF DID NOT NOTICE ANY DAMAGE TO THE CANNULA OR THE INSTRUMENT AFTER THE EVENT OCCURRED. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE FRAGMENT. NO POST-OPERATIVE TESTS LIKE AN X-RAY OR ULTRASOUND WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY REPORTED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO RETAINING A FOREIGN OBJECT. THE FRAGMENT WAS SENT FOR FAILURE ANALYSIS. THERE ARE NO IMAGES/VIDEO RECORDS 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": "" } ] }