{ "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": "2955842-2025-01619", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20250219", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250117", "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": "20250220", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20240725", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2725140", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250219", "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": "K12240725", "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": "10886874116408", "udi_public": "(01)10886874116408(10)K12240725", "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": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "02/20/2025;04/04/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "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": "20250219", "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": "20250123", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "21417328", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250123", "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": "369221851", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ON 04-APR-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: INITIAL FAILURE ANALYSIS WAS PARTIALLY CONFIRMED, IN THAT THE DAMAGE TO THE SEAL WAS CONFIRMED. HOWEVER, THE DAMAGE WAS FOUND TO BE LOCATED ON THE SEAL'S SEPTUM. THE SEAL WAS DISASSEMBLED DURING ADVANCED FAILURE ANALYSIS TO BETTER EXAMINE THE SEPTUM. THE SEAL WAS FOUND TO HAVE A ROUND HOLE IN ITS SEPTUM AND THE FRAGMENT WAS RETURNED WITH THE SEAL. THE FRAGMENT WAS PLACED ON THE HOLE IN THE SEPTUM AND APPEARED TO FIT, INDICATING IT COULD BE THE FRAGMENT THAT WAS GENERATED WHEN THE HOLE WAS CREATED. THE FRAGMENT ITSELF APPEARED TO HAVE A SLIGHT INDENTATION SLIGHTLY OFF CENTER FROM THE MIDDLE OF THE FRAGMENT. THE HOLE WAS OBSERVED TO BE LARGER THAN THE EXPECTED OPENING OF THE SEPTUM LOCATED AT THE CENTER. ADDITIONALLY, THE OBSERVED HOLE WAS FOUND TO BE SLIGHTLY OFFSET FROM THE EXPECTED OPENING." }, { "mdr_text_key": "369221852", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "363963750", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE UNIVERSAL SEAL FOR FAILURE ANALYSIS EVALUATION. A REVIEW OF AN IMAGE, PROVIDED BY THE CUSTOMER, OF THE UNIVERSAL SEAL WAS PERFORMED. THE IMAGE APPEARS TO SHOW A UNIVERSAL SEAL WITH A FRAGMENT BELOW IT. THE FRAGMENT APPEARS TO POTENTIALLY BE FROM THE UNIVERSAL SEAL¿S SEPTUM SEAL." }, { "mdr_text_key": "363963751", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, A BLACK PIECE OF PLASTIC MEASURING ABOUT 5 MM IN SIZE FELL OFF THE UNIVERSAL SEAL. A BACKUP UNIVERSAL SEAL WAS USED TO CONTINUE THE PROCEDURE, WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE BLACK FRAGMENT WAS FOUND INSIDE OF THE PATIENT¿S ANATOMY BUT WAS RETRIEVED DURING THE SAME PROCEDURE." }, { "mdr_text_key": "365916492", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DEVICE EVALUATION: INTUITIVE SURGICAL, INC. RECEIVED THE UNIVERSAL SEAL ACCESSORY TO PERFORM FAILURE ANALYSIS. THE SEAL WAS FOUND TO HAVE A TEAR ON THE BLACK RUBBER DUCKBILL. THE TORN PIECE WAS SEPARATED BUT RETURNED WITH THE SEAL. THERE WERE NO MISSING PIECES. A SECOND SEAL WAS ALSO RETURNED WITH NO DAMAGE AND NO PRODUCT ISSUE FOUND." } ], "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": "03/14/2025;04/28/2025" } ] }