{ "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": "2955842-2025-33620", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250811", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250704", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "PHYSICIAN", "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": "JA", "manufacturer_contact_area_code": "408", "date_added": "20250811", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20250103", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "282656", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250811", "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": "U12250103", "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)U12250103", "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": "09/03/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251103", "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": "20250811", "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": "20250717", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22770209", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250729", "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": "384086051", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "384086052", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SEAL WAS ANALYZED AND FOUND TO HAVE TEARS ON THE BLACK RUBBER DUCKBILL. THERE WERE TWO TORN PIECES, ONE AT THE BOTTOM OF THE SEAL WHERE IT ATTACHES TO THE CANNULA AND ONE AT THE INSERTION OF THE SEAL UNDERNEATH THE CLEAR PLASTIC. THE TORN PIECES WERE RETURNED, AND THERE WERE NO MISSING FRAGMENTS FOUND." }, { "mdr_text_key": "377292566", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SEAL HAS NOT BEEN RETURNED. A REVIEW OF THE PROVIDED IMAGE SHOWED THE FRAGMENT COULD POTENTIALLY BE FROM A UNIVERSAL SEAL¿S SEPTUM BASED ON THE APPEARANCE OF THE MATERIAL." }, { "mdr_text_key": "377292567", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, A BLACK OBJECT WAS FOUND IN THE BODY CAVITY DURING PROCEDURE AND WAS RETRIEVED. THE OBJECT WAS EXAMINED, AND IT WAS CONFIRMED THAT THE VALVE INSIDE THE UNIVERSAL SEAL WAS MISSING. IT WAS CONFIRMED THAT A FRAGMENT FELL INSIDE THE PATIENT DURING INSTRUMENT MANIPULATION, POSSIBLY DUE TO GETTING CAUGHT WHEN INSERTED AND REMOVED. ALL FRAGMENTS WERE RETRIEVED USING A DA VINCI INSTRUMENT, AND CONFIRMATION WAS MADE BY COMPARING THE COLLECTED FRAGMENTS WITH THE BROKEN UNIVERSAL SEAL. NO ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED, AND NO POST-OPERATIVE TESTS WERE CONDUCTED TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, WITH A DELAY OF APPROXIMATELY THIRTY MINUTES DUE TO FRAGMENT COLLECTION AND CONFIRMATION WORK. A BACKUP UNIVERSAL SEAL WAS NOT USED, AS THE DAMAGE WAS CONFIRMED JUST BEFORE THE PROCEDURE ENDED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT." } ], "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": "09/15/2025" } ] }