{ "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": "2955842-2025-33351", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20250811", "manufacturer_address_2": "", "pma_pmn_number": "K181395", "date_of_event": "20250714", "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", "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "KS", "manufacturer_contact_area_code": "408", "date_added": "20250811", "manufacturer_contact_f_name": "IZABEL", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2412958", "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": "N/A", "other_id_number": "", "device_availability": "No", "device_report_product_code": "GCJ", "device_age_text": "DA", "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 Split, Cut or Torn", "Material Split, Cut or Torn" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/12/2025", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20251027", "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": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Insufficient Information", "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": "22770776", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20250717", "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": "382781607", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "382781608", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION: INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER WHO CONFIRMED THAT THE UNIVERSAL SEAL WAS INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING OUT OF THE ORDINARY WAS NOTED. DURING THE INSERTION OF THE INSTRUMENT, A BLACK FRAGMENT FELL INSIDE THE PATIENT, WHICH WAS OBSERVED ON THE SCREEN AND IMMEDIATELY REMOVED. THE SURGEON BELIEVED THE CAUSE OF THE FRAGMENT FALLING ISSUE WAS EITHER A DEFECTIVE PRODUCT OR IT BEING STABBED BY A ROBOTIC INSTRUMENT. THE ACCESSORY WAS IN USE FOR LESS THAN AN HOUR BEFORE THE ISSUE OCCURRED. NO ISSUES WITH THE FUNCTIONALITY OF THE INSTRUMENT WERE NOTICED DURING THE SURGICAL PROCEDURE, AND THERE WERE NO COLLISIONS WITH OTHER INSTRUMENTS OR HARD MATERIALS. THE FRAGMENT DID NOT FALL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION. THE SURGICAL STAFF DID NOT FEEL ANY RESISTANCE UPON REMOVAL OF THE INSTRUMENT THROUGH THE CANNULA. UPON FINAL REMOVAL, NO DAMAGE WAS NOTICED TO THE CANNULA OR OTHER INSTRUMENTS. THE FRAGMENTS WERE RETRIEVED USING A LAPAROSCOPIC INSTRUMENT, AND ALL PIECES WERE MATCHED TO CONFIRM RETRIEVAL. NO ADDITIONAL SURGICAL PROCEDURES WERE REQUIRED TO REMOVE THE FRAGMENT, AND NO POST-OPERATIVE TESTS WERE PERFORMED. THE PROCEDURE WAS COMPLETED ROBOTICALLY, WITH NO INJURY TO THE PATIENT. THE PATIENT DID NOT RETURN TO THE HOSPITAL FOR POST-SURGICAL COMPLICATIONS." }, { "mdr_text_key": "377297011", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, USING THE NEWLY RELEASED UNIVERSAL SEAL 5-12MM, THE MEMBRANE TORE, AND FRAGMENTS DETACHED. IT WAS UNCLEAR IF ANY FRAGMENTS FELL INSIDE THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT." }, { "mdr_text_key": "377297015", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE UNIVERSAL SEAL TO PERFORM FAILURE ANALYSIS. AN IMAGE WAS PROVIDED WHICH APPEARED TO SHOW A BLACK FRAGMENT BROKEN OFF FROM THE UNIVERSAL SEAL SEPTUM." } ], "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": "08/27/2025" } ] }