{ "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": "2955842-2025-31856", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20250729", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250715", "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", "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": "20250729", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2820529", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20250729", "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": "No", "device_report_product_code": "GCJ", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250828", "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": "20250729", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "66 YR", "patient_sex": "Male", "patient_weight": "110 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250715", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "22643184", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250715", "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": "376171056", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A ROBOTIC HELLER MYOTOMY, A FRAGMENT DETACHED FROM THE CANNULA SEAL AND FELL INSIDE THE PATIENT. THERE WAS UNCERTAINTY ABOUT ITS ORIGIN, WHETHER IT WAS FROM THE PRODUCT ITSELF OR ALREADY PRESENT IN THE TROCAR DUE TO PACKAGING OR MANUFACTURING. THE FRAGMENT WAS RETRIEVED USING A MARYLAND INSTRUMENT VIA THE ASSIST PORT, BUT THERE WAS UNCERTAINTY ABOUT THE COMPLETENESS OF THE RETRIEVAL DUE TO THE SMALL SIZE OF THE FRAGMENTS, WHICH MEASURED APPROXIMATELY 2MM X < 1MM. NO ADDITIONAL SURGICAL PROCEDURES WERE NECESSARY TO REMOVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS LIKE X-RAYS OR ULTRASOUNDS WERE CONDUCTED TO VERIFY THE PRESENCE OF REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY, AND THERE HAS BEEN NO HOSPITAL RETURN DUE TO POST-SURGICAL COMPLICATIONS RELATED TO RETAINING FOREIGN OBJECTS." }, { "mdr_text_key": "376171057", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE UNIVERSAL SEAL IS UNAVAILABLE FOR RETURN TO ISI FOR EVALUATION. A REVIEW OF THE PROVIDED IMAGE SHOWS THE FRAGMENT COULD BE FROM A UNIVERSAL SEAL¿S DUCKBILL COMPONENT BASED ON THE COLOR AND SIZE OF THE FRAGMENT, BUT FOR FURTHER CONFIRMATION THE FRAGMENT WOULD NEED TO BE RETURNED FOR FURTHER TESTING AND INSPECTION. PATIENT DEMOGRAPHICS: BODY MASS INDEX (BMI): 33 KG/M2. HEIGHT: 71 INCHES." } ], "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": "" } ] }